PMPRB Annual Report 2016

PMPRB PATENTED DRUG PRODUCTS FOR HUMAN USE REPORTED TO THE PMPRB IN 2016∗ JANUARY 1 – DECEMBER 31, 2016

Abbott Laboratories Limited

DIN Brand Name Chemical Name ATC Dosage Comments Status

02165503 PREVACID - lansoprazole A02BC Oral Solid Does Not 15 MG/CAPSULE /Modified Trigger release capsules

02165511 PREVACID - lansoprazole A02BC Oral Solid Within 30 MG/CAPSULE /Modified Guidelines release capsules

02249464 PREVACID FASTAB - lansoprazole A02BC Oral Solid Within 15 MG/TAB /Tablet Guidelines

02249472 PREVACID FASTAB - lansoprazole A02BC Oral Solid Does Not 30 MG/TAB /Tablet Trigger

∗ Does not include drug products introduced or patented in December 2016. Patented Drug Products for Human Use Reported to the PMPRB in 2016 1

PMPRB Annual Report 2016

Abbvie

DIN Brand Name Chemical Name ATC Dosage Comments Status

02436027 HOLKIRA PAK ombitasvir/paritaprevir/ J05AX Oral Solid Within 12.5/75/50/250 ritonavir/dasabuvir /Tablet Guidelines

02258595 HUMIRA - adalimumab L04AA Parenteral Within 40 MG/SYRINGE /Solution Guidelines

02458357 HUMIRA - adalimumab L04AA Parenteral Introduced Under 40 MG/PEN /Solution Review

02458349 HUMIRA - adalimumab L04AA Parenteral Introduced Under 40 MG/SYRINGE /Solution Review

02312301 KALETRA 100/25 lopinavir / ritonavir J05AE Oral Solid Within /Tablet Guidelines

02285533 KALETRA 200/50 lopinavir / ritonavir J05AE Oral Solid Within /Tablet Guidelines

02243644 KALETRA 80/20 lopinavir / ritonavir J05AE Oral Liquid Within /Solution Guidelines

00884502 LUPRON DEPOT - leuprolide acetate L02AE Parenteral Within 3.75 MG/VIAL /Modified Guidelines release injections

00836273 LUPRON DEPOT - leuprolide acetate L02AE Parenteral Within 7.5 MG/VIAL /Modified Guidelines release injections

02239834 LUPRON DEPOT - leuprolide acetate L02AE Parenteral Within 11.25 MG/VIAL /Modified Guidelines release injections

Patented Drug Products for Human Use Reported to the PMPRB in 2016 2

PMPRB Annual Report 2016

02230248 LUPRON DEPOT - leuprolide acetate L02AE Parenteral Within 22.5 MG/VIAL /Modified Guidelines release injections

02239833 LUPRON DEPOT - leuprolide acetate L02AE Parenteral Within 30 MG/VIAL /Modified Guidelines release injections

02229145 NORVIR - ritonavir J05AE Oral Liquid Within 80 MG/MILLILITER /Solution Guidelines

02357593 NORVIR - ritonavir J05AE Oral Solid Within 100 MG/TAB /Tablet Guidelines

02172763 SEVORANE sevoflurane N01AB Pulmonary Within /Solution Guidelines

02245889 SYNAGIS - palivizumab J06BB Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02245890 SYNAGIS - palivizumab J06BB Parenteral Within 100 MG/VIAL /Powder for Guidelines solution

02438372 SYNAGIS - palivizumab J06BB Parenteral Introduced Under 50 MG/VIAL /Solution Review

02438364 SYNAGIS - palivizumab J06BB Parenteral Introduced Under 100 MG/VIAL /Solution Review

02447711 TECHNIVIE ombitasvir/paritaprevir/ritona J05AX Oral Solid Within 12.5/75/50 vir /Tablet Guidelines

02458039 VENCLEXTA - venetoclax L01XX Oral Solid Introduced Under 10 MG/TAB /Tablet Review

Patented Drug Products for Human Use Reported to the PMPRB in 2016 3

PMPRB Annual Report 2016

02458047 VENCLEXTA - venetoclax L01XX Oral Solid Introduced Under 50 MG/TAB /Tablet Review

02458055 VENCLEXTA - venetoclax L01XX Oral Solid Introduced Under 100 MG/TAB /Tablet Review

02458063 VENCLEXTA venetoclax L01XX Oral Solid Introduced Under 10/50/100 /Tablet Review

02266202 ZEMPLAR - paricalcitol A11CC Parenteral Expired Within 5 MCG/MILLILITER /Solution Guidelines

Acerus Pharmaceuticals SRL

DIN Brand Name Chemical Name ATC Dosage Comments Status

02450550 NATESTO - testosterone G03BA Nasal Introduced Does Not 5.5 MG/ACTUATION /Other Trigger

Actelion Pharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02397447 CARIPUL - epoprostenol sodium B01AC Parenteral Within 0.5 MG/VIAL /Powder for Guidelines solution

02397455 CARIPUL - epoprostenol sodium B01AC Parenteral Within 1.5 MG/VIAL /Powder for Guidelines solution

02415690 OPSUMIT - macitentan C02KX Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02337630 TOCTINO - alitretinoin D11AX Oral Solid Within 10 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 4

PMPRB Annual Report 2016

02337649 TOCTINO - alitretinoin D11AX Oral Solid Within 30 MG/CAPSULE /Capsule Guidelines

02244981 TRACLEER - bosentan (bosentan C02KX Oral Solid Within 62.5 MG/TAB monohydrate) /Tablet Guidelines

02244982 TRACLEER - bosentan (bosentan C02KX Oral Solid Within 125 MG/TAB monohydrate) /Tablet Guidelines

02451158 UPTRAVI - selexipag B01AC Oral Solid Introduced Subj. 200 MCG/TAB /Tablet Investigation

02451166 UPTRAVI - selexipag B01AC Oral Solid Introduced Does Not 400 MCG/TAB /Tablet Trigger

02451174 UPTRAVI - selexipag B01AC Oral Solid Introduced Within 600 MCG/TAB /Tablet Guidelines

02451182 UPTRAVI - selexipag B01AC Oral Solid Introduced Subj. 800 MCG/TAB /Tablet Investigation

02451190 UPTRAVI - selexipag B01AC Oral Solid Introduced Does Not 1000 MCG/TAB /Tablet Trigger

02451204 UPTRAVI - selexipag B01AC Oral Solid Introduced Within 1200 MCG/TAB /Tablet Guidelines

02451212 UPTRAVI - selexipag B01AC Oral Solid Introduced Does Not 1400 MCG/TAB /Tablet Trigger

02451220 UPTRAVI - selexipag B01AC Oral Solid Introduced Subj. 1600 MCG/TAB /Tablet Investigation

02250519 ZAVESCA - miglustat A16AX Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 5

PMPRB Annual Report 2016

Aegerion Pharmaceuticals (Canada) Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02420376 JUXTAPID - lomitapide C10AX Oral Solid Expired Within 10 MG/CAPSULE /Capsule Guidelines

02420384 JUXTAPID - lomitapide C10AX Oral Solid Expired Within 20 MG/CAPSULE /Capsule Guidelines

Alcon Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02331624 AZARGA 1/0.5 brinzolamide/timolol maleate S01ED Ophthalmic Subj. /Suspension Investigation

02238873 AZOPT - brinzolamide S01EC Ophthalmic Within 10 MG/MILLILITER /Suspension Guidelines

02252716 CIPRODEX - ciprofloxacin hydrochloride / S02CA Otic Within 4 MG/MILLILITER dexamethasone /Suspension Guidelines

02278251 DUOTRAV PQ - travoprost/timolol maleate S01ED Ophthalmic Subj. 5.04 MG/MILLILITER /Liquid Investigation

02411393 ILEVRO - nepafenac S01BC Ophthalmic Within 3 MG/MILLILITER /Suspension Guidelines

02410818 JETREA - ocriplasmin S01XA Ophthalmic Within 2.5 MG/MILLILITER /Other Guidelines

02308983 NEVANAC - nepafenac S01BC Ophthalmic Does Not 1 MG/MILLILITER /Suspension Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 6

PMPRB Annual Report 2016

02362171 PATADAY - olopatadine hydrochloride S01GX Ophthalmic Does Not 2 MG/MILLILITER /Liquid Trigger

02233143 PATANOL - olopatadine hydrochloride S01GX Ophthalmic Within 1 MG/MILLILITER /Liquid Guidelines

02435411 SIMBRINZA brinzolamide/brimonidine S01EC Ophthalmic Does Not tartrate /Suspension Trigger

02318008 TRAVATAN Z - travoprost S01EE Ophthalmic Does Not 0.04 MG/MILLILITER /Liquid Trigger

02368676 TRIESENCE - triamcinolone acetonide S01BA Ophthalmic Does Not 40 MG/MILLILITER /Other Trigger

02163691 VEXOL - rimexolone S01BA Ophthalmic Does Not 10 MG/MILLILITER /Suspension Trigger

02252260 VIGAMOX - moxifloxacin hydrochloride S01AX Ophthalmic Does Not 5 MG/MILLILITER /Liquid Trigger

Alexion Pharmaceuticals Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02322285 SOLIRIS - eculizumab L04AA Parenteral Notice of 10 MG/MILLILITER /Solution Hearing

02444615 STRENSIQ - asfotase alfa A16AB Parenteral Introduced Under Review 18 MG/VIAL /Solution

02444658 STRENSIQ - asfotase alfa A16AB Parenteral Introduced Under Review 80 MG/VIAL /Solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 7

PMPRB Annual Report 2016

Allergan Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02242518 ACTONEL - risedronate M05BA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02239146 ACTONEL - risedronate M05BA Oral Solid Within 30 MG/TAB /Tablet Guidelines

02246896 ACTONEL - risedronate M05BA Oral Solid Within 35 MG/TAB /Tablet Guidelines

02316838 ACTONEL - risedronate M05BA Oral Solid Subj. 150 MG/TAB /Tablet Investigation

02370417 ACTONEL DR - risedronate M05BA Oral Solid Subj. 35 MG/TAB /Modified Investigation release tablets

01968300 ACULAR - ketorolac tromethamine S01BC Ophthalmic Within 5 MG/MILLILITER /Liquid Guidelines

02248722 ACULAR LS - ketorolac tromethamine S01BC Ophthalmic Does Not 4 MG/MILLILITER /Liquid Trigger

02369362 ACUVAIL - ketorolac tromethamine S01BC Ophthalmic Within 4.5 MG/MILLILITER /Drops Guidelines

02236876 ALPHAGAN - brimonidine tartrate S01EA Ophthalmic Within 2 MG/MILLILITER /Drops Guidelines

02248151 ALPHAGAN P - brimonidine tartrate S01EA Ophthalmic Within 1.5 MG/MILLILITER /Liquid Guidelines

02239653 ANDRODERM - testosterone G03BA Topical Expired Subj. 12.2 MG/PATCH /Patches Investigation

Patented Drug Products for Human Use Reported to the PMPRB in 2016 8

PMPRB Annual Report 2016

02245972 ANDRODERM - testosterone G03BA Topical Subj. 24.3 MG/PATCH /Patches Investigation

01997580 ASACOL 400 - 5-aminosalicyclic acid A07EC Oral Solid Does Not 400 MG/TAB (mesalamine) /Modified Trigger release tablets

02267217 ASACOL 800 - 5-aminosalicyclic acid A07EC Oral Solid Within 800 MG/TAB (mesalamine) /Modified Guidelines release tablets

02443910 BELKYRA - deoxycholic acid D11AX Parenteral Introduced Does Not 10 MG/MILLILITER /Solution Trigger

01981501 BOTOX - onabotulinumtoxina M03AX Parenteral Within 100 UNIT/VIAL /Powder for Guidelines solution

02243721 BOTOX COSMETIC - onabotulinumtoxina M03AX Parenteral Within 100 UNIT/VIAL /Powder for Guidelines solution

02248347 COMBIGAN 2/5 brimonidine tartrate/timolol S01ED Ophthalmic Within maleate /Drops Guidelines

02417162 CONSTELLA - linaclotide A06AX Oral Solid Does Not 145 MCG/CAPSULE /Capsule Trigger

02417170 CONSTELLA - linaclotide A06AX Oral Solid Within 290 MCG/CAPSULE /Capsule Guidelines

02436329 ELLA - 30 MG/TAB ulipristal acetate G03XB Oral Solid Within /Tablet Guidelines

02440970 FETZIMA - levomilnacipran N06AX Oral Solid Within 20 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 9

PMPRB Annual Report 2016

02440989 FETZIMA - levomilnacipran N06AX Oral Solid Within 40 MG/CAPSULE /Capsule Guidelines

02440997 FETZIMA - levomilnacipran N06AX Oral Solid Introduced Within 80 MG/CAPSULE /Capsule Guidelines

02441004 FETZIMA - levomilnacipran N06AX Oral Solid Introduced Within 120 MG/CAPSULE /Capsule Guidelines

02408163 FIBRISTAL - ulipristal acetate G03XB Oral Solid VCU 5 MG/TAB /Tablet

02366150 GELNIQUE - oxybutynin chloride G04BD Topical /Gel Subj. 100 MG/GRAM Investigation

02350939 LATISSE - bimatoprost S01EE Topical Within 0.3 MG/MILLILITER /Liquid Guidelines

02417456 LOLO 1/0.1 norethindrone acetate/ ethinyl G03AA Oral Solid Within estradiol/ ethinyl estradiol /Tablet Guidelines

02324997 LUMIGAN - bimatoprost S01EE Ophthalmic Within 0.1 MG/MILLILITER /Liquid Guidelines

02254735 OXYTROL - oxybutynin G04BD Topical Expired Does Not 36 MG/PATCH /Patches Trigger

02363445 OZURDEX - dexamethasone S01BA Ophthalmic Within 0.7 MG/IMPLANT /Modified Guidelines release ocular devices

02361663 RAPAFLO - silodosin G04CA Oral Solid Within 4 MG/CAPSULE /Capsule Guidelines

02361671 RAPAFLO - silodosin G04CA Oral Solid Within 8 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 10

PMPRB Annual Report 2016

02355655 RESTASIS - cyclosporine S01XA Ophthalmic Does Not 0.2 MG/VIAL /Liquid Trigger

02296659 SEASONALE levonorgestrel/ ethinyl G03AA Oral Solid Within 0.15/0.03 estradiol /Tablet Guidelines

02346176 SEASONIQUE levonorgestrel/ ethinyl G03AA Oral Solid Within 0.15/0.03-0.01 estradiol /Tablet Guidelines

02243894 TAZORAC - tazarotene D05AX Topical Within 0.5 MG/GRAM /Cream Guidelines

02243895 TAZORAC - tazarotene D05AX Topical Within 1 MG/GRAM /Cream Guidelines

02230784 TAZORAC - tazarotene D05AX Topical /Gel Does Not 0.5 MG/GRAM Trigger

02230785 TAZORAC - tazarotene D05AX Topical /Gel Within 1 MG/GRAM Guidelines

TEFLARO - ceftaroline fosamil J01DI Parenteral Does Not 600 MG/VIAL /Powder for Trigger solution

02240000 TRELSTAR - triptorelin pamoate J01DI Parenteral Under Reivew 3.75 MG/VIAL /Powder for solution

02243856 TRELSTAR - triptorelin pamoate J01DI Parenteral Under Reivew 11.25 MG/VIAL /Powder for solution

02412322 TRELSTAR - triptorelin pamoate L02AE Parenteral Within 22.5 MG/VIAL /Powder for Guidelines solution

02257270 ZYMAR - gatifloxacin S01AX Ophthalmic Does Not 3 MG/MILLILITER /Liquid Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 11

PMPRB Annual Report 2016

Amgen Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02450283 BLINCYTO - blinatumomab L01XC Parenteral Introduced Within 38.5 MCG/VIAL /Powder for Guidelines solution

02242903 ENBREL - etanercept L04AA Parenteral Within 25 MG/VIAL /Solution Guidelines

02274728 ENBREL - etanercept L04AA Parenteral Within 50 MG/MILLILITER /Solution Guidelines

02451034 KYPROLIS - carfilzomib L01XX Parenteral Introduced Does Not 60 MG/VIAL /Powder for Trigger solution

02249790 NEULASTA - pegfilgrastim L03AA Parenteral Within 10 MG/MILLILITER /Solution Guidelines

02420104 NEUPOGEN - filgrastim L03AA Parenteral Introduced Within 0.6 MG/MILLILITER /Solution Guidelines

02420112 NEUPOGEN - filgrastim L03AA Parenteral Introduced Within 0.6 MG/MILLILITER /Solution Guidelines

01968017 NEUPOGEN - filgrastim L03AA Parenteral Within 0.3 MG/MILLILITER /Solution Guidelines

02343541 PROLIA - denosumab M05BX Parenteral Within 60 MG/SYRINGE /Solution Guidelines

02446057 REPATHA - evolocumab C10AX Parenteral Subj. 140 MG/SYRINGE /Solution Investigation

02257130 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Within 30 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 12

PMPRB Annual Report 2016

02257149 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Within 60 MG/TAB /Tablet Guidelines

02257157 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Within 90 MG/TAB /Tablet Guidelines

02308487 VECTIBIX - panitumumab L01XC Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02368153 XGEVA - denosumab M05BX Parenteral Within 120 MG/VIAL /Solution Guidelines

Aspri Pharma Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02087286 ALKERAN - melphalan hydrochloride L01AA Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02245531 ARIXTRA - fondaparinux sodium B01AX Parenteral Within 2.5 MG/SYRINGE /Solution Guidelines

02258056 ARIXTRA - fondaparinux sodium B01AX Parenteral Does Not 7.5 MG/MILLILITER /Solution Trigger

02441853 PANTOPRAZOLE pantoprazole magnesium A02BC Oral Solid Within MAGNESIUM - /Tablet Guidelines 40 MG/TAB

Patented Drug Products for Human Use Reported to the PMPRB in 2016 13

PMPRB Annual Report 2016

Astellas Pharma Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02296462 ADVAGRAF - tacrolimus L04AD Oral Solid Within 0.5 MG/CAPSULE /Modified Guidelines release capsules

02296470 ADVAGRAF - tacrolimus L04AD Oral Solid Within 1 MG/CAPSULE /Modified Guidelines release capsules

02331667 ADVAGRAF - tacrolimus L04AD Oral Solid Within 3 MG/CAPSULE /Modified Guidelines release capsules

02296489 ADVAGRAF - tacrolimus L04AD Oral Solid Within 5 MG/CAPSULE /Modified Guidelines release capsules

02294222 MYCAMINE - micafungin sodium J02AX Parenteral Subj. 50 MG/VIAL /Powder for Investigation solution

02311054 MYCAMINE - micafungin sodium J02AX Parenteral Within 100 MG/VIAL /Powder for Guidelines solution

02402874 MYRBETRIQ - mirabegron G04BD Oral Solid Within 25 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 14

PMPRB Annual Report 2016

02402882 MYRBETRIQ - mirabegron G04BD Oral Solid Within 50 MG/TAB /Modified Guidelines release tablets

02407329 XTANDI - enzalutamide L02BB Oral Solid Within 40 MG/CAPSULE /Capsule Guidelines

Astrazeneca Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02236606 ACCOLATE - zafirlukast R03DC Oral Solid Expired Within 20 MG/TAB /Tablet Guidelines

02224135 ARIMIDEX - anastrozole L02BG Oral Solid Within 1 MG/TAB /Tablet Guidelines

00786616 BRICANYL terbutaline sulfate R03AC Pulmonary Within TURBUHALER - /Metered Guidelines 0.5 MG/DOSE dose preparations

02455005 BRILINTA - ticagrelor B01AC Oral Solid Introduced Within 60 MG/TAB /Tablet Guidelines

02368544 BRILINTA - ticagrelor B01AC Oral Solid Within 90 MG/TAB /Tablet Guidelines

02448610 BYDUREON - exenatide A10BX Parenteral Introduced Within 2 MG/DOSE /Modified Guidelines release injections

02361809 BYETTA - exenatide A10BX Parenteral Does Not 5 MCG/DOSE /Solution Trigger

02361817 BYETTA - exenatide A10BX Parenteral Within 10 MCG/DOSE /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 15

PMPRB Annual Report 2016

02265540 CRESTOR - rosuvastatin calcium C10AA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02247162 CRESTOR - rosuvastatin calcium C10AA Oral Solid Within 10 MG/TAB /Tablet Guidelines

02247163 CRESTOR - rosuvastatin calcium C10AA Oral Solid Within 20 MG/TAB /Tablet Guidelines

02247164 CRESTOR - rosuvastatin calcium C10AA Oral Solid Within 40 MG/TAB /Tablet Guidelines

02439530 DUAKLIR GENUAIR aclidinium bromide / R03AL Pulmonary Within 400/12 formoterol fumarate /Powder Guidelines dihydrate

02248624 FASLODEX - fulvestrant L02BA Parenteral Within 250 MG/SYRINGE /Solution Guidelines

02426544 FLUMIST influenza vaccine (live, J07BB Nasal /Spray Within QUADRIVALENT - attenuated) Guidelines 0.2 UNIT/DOSE

02435462 FORXIGA - dapagliflozin propanediol A10BX Oral Solid Within 5 MG/TAB monohydrate /Tablet Guidelines

02435470 FORXIGA - dapagliflozin propanediol A10BX Oral Solid Within 10 MG/TAB monohydrate /Tablet Guidelines

02248676 IRESSA - gefitinib L01XX Oral Solid Expired Within 250 MG/TAB /Tablet Guidelines

02389185 KOMBOGLYZE saxagliptin/metformin A10BD Oral Solid Within 1000/2.5 /Tablet Guidelines

02389169 KOMBOGLYZE saxagliptin/metformin A10BD Oral Solid Within 500/2.5 /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 16

PMPRB Annual Report 2016

02389177 KOMBOGLYZE saxagliptin/metformin A10BD Oral Solid Within 850/2.5 /Tablet Guidelines

00846503 LOSEC - omeprazole A02BC Oral Solid Within 20 MG/CAPSULE /Capsule Guidelines

02230737 LOSEC - omeprazole magnesium A02BC Oral Solid Does Not 10 MG/TAB /Modified Trigger release tablets

02190915 LOSEC - omeprazole magnesium A02BC Oral Solid Within 20 MG/TAB /Modified Guidelines release tablets

02454408 LYNPARZA - olaparib L01XX Oral Solid Introduced Subj. 50 MG/CAPSULE /Capsule Investigation

02442167 MOVANTIK - naloxegol oxalate A06AH Oral Solid Within 12.5 MG/TAB /Tablet Guidelines

02442175 MOVANTIK - naloxegol oxalate A06AH Oral Solid Within 25 MG/TAB /Tablet Guidelines

02300524 NEXIUM - esomeprazole A02BC Oral Solid Within 10 MG/POUCH /Effervescent Guidelines granules

02244521 NEXIUM - esomeprazole A02BC Oral Solid Within 20 MG/TAB /Modified Guidelines release tablets

02244522 NEXIUM - esomeprazole A02BC Oral Solid Within 40 MG/TAB /Modified Guidelines release tablets

02375842 ONGLYZA - saxagliptin A10BH Oral Solid Within 2.5 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 17

PMPRB Annual Report 2016

02333554 ONGLYZA - saxagliptin A10BH Oral Solid Within 5 MG/TAB /Tablet Guidelines

02237225 OXEZE TURBUHALER - formoterol fumarate R03AC Pulmonary Within 0.006 MG/DOSE /Powder Guidelines

02237224 OXEZE TURBUHALER - formoterol fumarate R03AC Pulmonary Within 0.012 MG/DOSE /Powder Guidelines

02057778 PLENDIL - felodipine C08CA Oral Solid Expired Within 2.5 MG/TAB /Modified Guidelines release tablets

00851779 PLENDIL - felodipine C08CA Oral Solid Expired Within 5 MG/TAB /Modified Guidelines release tablets

00851787 PLENDIL - felodipine C08CA Oral Solid Expired Does Not 10 MG/TAB /Modified Trigger release tablets

02229099 PULMICORT budesonide R03BA Pulmonary Within NEBUAMP - /Other Guidelines 0.125 MG/MILLILITER

01978918 PULMICORT budesonide R03BA Pulmonary Within NEBUAMP - /Other Guidelines 0.25 MG/MILLILITER

01978926 PULMICORT budesonide R03BA Pulmonary Within NEBUAMP - /Other Guidelines 0.5 MG/MILLILITER

00852074 PULMICORT budesonide R03BA Pulmonary Within TURBUHALER - /Powder Guidelines 0.1 MG/DOSE

Patented Drug Products for Human Use Reported to the PMPRB in 2016 18

PMPRB Annual Report 2016

00851752 PULMICORT budesonide R03BA Pulmonary Within TURBUHALER - /Powder Guidelines 0.2 MG/DOSE

00851760 PULMICORT budesonide R03BA Pulmonary Within TURBUHALER - /Powder Guidelines 0.4 MG/DOSE

02035324 RHINOCORT budesonide R01AD Nasal Within TURBUHALER - /Powder Guidelines 0.1 MG/DOSE

02236951 SEROQUEL - quetiapine fumarate N05AH Oral Solid Within 25 MG/TAB /Tablet Guidelines

02236952 SEROQUEL - quetiapine fumarate N05AH Oral Solid Does Not 100 MG/TAB /Tablet Trigger

02236953 SEROQUEL - quetiapine fumarate N05AH Oral Solid Does Not 200 MG/TAB /Tablet Trigger

02244107 SEROQUEL - quetiapine fumarate N05AH Oral Solid Subj. 300 MG/TAB /Tablet Investigation

02300184 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Does Not 50 MG/TAB /Modified Trigger release tablets

02321513 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Does Not 150 MG/TAB /Modified Trigger release tablets

02300192 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Within 200 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 19

PMPRB Annual Report 2016

02300206 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Within 300 MG/TAB /Modified Guidelines release tablets

02300214 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Subj. 400 MG/TAB /Modified Investigation release tablets

02245385 SYMBICORT budesonide/formoterol R03AK Pulmonary Within 100/6 TURBUHALER fumarate /Powder Guidelines

02245386 SYMBICORT budesonide/formoterol R03AK Pulmonary Within 200/6 TURBUHALER fumarate /Powder Guidelines

02456214 TAGRISSO - osimertinib L01XE Oral Solid Introduced Within 40 MG/TAB /Tablet Guidelines

02456222 TAGRISSO - osimertinib L01XE Oral Solid Introduced Within 80 MG/TAB /Tablet Guidelines

02409720 TUDORZA GENUAIR - aclidinium bromide R03BB Pulmonary Within 400 MCG/DOSE /Powder Guidelines

02361701 VIMOVO 20/375 naproxen / esomeprazole M01AE Oral Solid Within magnesium trihydrate /Modified Guidelines release tablets

02361728 VIMOVO 20/500 naproxen / esomeprazole M01AE Oral Solid Within magnesium trihydrate /Modified Guidelines release tablets

02449943 XIGDUO 5/1000 dapagliflozin/ metformin A10BD Oral Solid Introduced Subj. hydrochloride /Tablet Investigation

02449935 XIGDUO 5/850 dapagliflozin/ metformin A10BD Oral Solid Introduced Subj. hydrochloride /Tablet Investigation

Patented Drug Products for Human Use Reported to the PMPRB in 2016 20

PMPRB Annual Report 2016

02248992 ZOMIG - zolmitriptan N02CC Nasal /Spray Expired Within 2.5 MG/DOSE Guidelines

02248993 ZOMIG - zolmitriptan N02CC Nasal /Spray Expired Within 5 MG/DOSE Guidelines

02238660 ZOMIG - zolmitriptan N02CC Oral Solid Expired Within 2.5 MG/TAB /Tablet Guidelines

02243045 ZOMIG RAPIMELT - zolmitriptan N02CC Oral Solid Expired Within 2.5 MG/TAB /Tablet Guidelines

Baxalta Canada Corporation

DIN Brand Name Chemical Name ATC Dosage Comments Status

02284154 ADVATE 1000 (WITH antihemophilic factor B02BD Parenteral Subj. 5ML DILUENT) (recombinant), /Powder for Investigation plasma/albumin free method solution (rahf-pfm)

02284162 ADVATE 1500 (WITH antihemophilic factor B02BD Parenteral Subj. 5ML DILUENT) (recombinant), /Powder for Investigation plasma/albumin free method solution (rahf-pfm)

02313111 ADVATE 2000 (WITH antihemophilic factor B02BD Parenteral Subj. 5ML DILUENT) (recombinant), /Powder for Investigation plasma/albumin free method solution (rahf-pfm)

02365944 ADVATE 250 (WITH antihemophilic factor B02BD Parenteral Does Not 2ML DILUENT) (recombinant), /Powder for Trigger plasma/albumin free method solution (rahf-pfm)

Patented Drug Products for Human Use Reported to the PMPRB in 2016 21

PMPRB Annual Report 2016

02337193 ADVATE 3000 (WITH antihemophilic factor B02BD Parenteral Subj. 5ML DILUENT) (recombinant), /Powder for Investigation plasma/albumin free method solution (rahf-pfm)

02365952 ADVATE 500 (WITH antihemophilic factor B02BD Parenteral Subj. 2ML DILUENT) (recombinant), /Powder for Investigation plasma/albumin free method solution (rahf-pfm)

02206021 IMMUNINE VH factor ix concentrate B02BD Parenteral Subj. /Powder for Investigation solution

ONCASPAR - l-asparaginase L01XX Parenteral VCU 750 UNIT/MILLILITER /Solution

Baxter Corporation

DIN Brand Name Chemical Name ATC Dosage Comments Status

02326167 ARTISS VHSD - fibrin sealant B02BC Topical Does Not 4 UNIT/MILLILITER /Powder Trigger

02188880 BREVIBLOC - esmolol hydrochloride C07AB Parenteral Within 10 MG/MILLILITER /Solution Guidelines

02309238 BREVIBLOC - esmolol hydrochloride C07AB Parenteral Does Not 10 MG/MILLILITER /Solution Trigger

02326132 TISSEEL VHSD - fibrin sealant B02BC Topical Does Not 500 UNIT/MILLILITER /Powder Trigger

02326175 TISSEEL VHSD fibrin sealant B02BC Topical Within (FROZEN) - /Powder Guidelines 500 UNIT/MILLILITER

Patented Drug Products for Human Use Reported to the PMPRB in 2016 22

PMPRB Annual Report 2016

Bayer Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02412764 ADEMPAS - riociguat C02KX Oral Solid Does Not 0.5 MG/TAB /Tablet Trigger

02412772 ADEMPAS - riociguat C02KX Oral Solid Within 1 MG/TAB /Tablet Guidelines

02412799 ADEMPAS - riociguat C02KX Oral Solid Within 1.5 MG/TAB /Tablet Guidelines

02412802 ADEMPAS - riociguat C02KX Oral Solid Within 2 MG/TAB /Tablet Guidelines

02412810 ADEMPAS - riociguat C02KX Oral Solid Within 2.5 MG/TAB /Tablet Guidelines

02268825 ANGELIQ 1/1 drospirenone/estradiol 17ß G03FA Oral Solid Within /Tablet Guidelines

02242965 AVELOX - moxifloxacin hydrochloride J01MA Oral Solid Expired Within 400 MG/TAB /Tablet Guidelines

02246414 AVELOX - moxifloxacin hydrochloride J01MA Parenteral Expired Within 1.6 MG/MILLILITER /Solution Guidelines

02169649 BETASERON - interferon beta-1b L03AB Parenteral Expired Within 0.3 MG/VIAL /Powder for Guidelines solution

02247916 CIPRO XL - ciprofloxacin hydrochloride J01MA Oral Solid Within 500 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 23

PMPRB Annual Report 2016

02251787 CIPRO XL - ciprofloxacin hydrochloride J01MA Oral Solid Within 1000 MG/TAB /Modified Guidelines release tablets

02415992 EYLEA - aflibercept S01LA Pulmonary Within 40 MG/MILLILITER /Solution Guidelines

02270811 FINACEA - azelaic acid D10AX Topical /Gel Within 150 MG/GRAM Guidelines

02241089 GADOVIST gadobutrol V08CA Parenteral Within 1,0 - 604.72 MG/ /Solution Guidelines MILLILITER

02190885 GLUCOBAY - acarbose A10BF Oral Solid Within 50 MG/TAB /Tablet Guidelines

02190893 GLUCOBAY - acarbose A10BF Oral Solid Within 100 MG/TAB /Tablet Guidelines

02408295 JAYDESS - levonorgestrel G02BA Vaginal Within 13 MG/UNIT /Insert Guidelines

02342731 KOGENATE FS antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02302217 KOGENATE FS antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02291533 KOGENATE FS antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02291525 KOGENATE FS antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 24

PMPRB Annual Report 2016

02291517 KOGENATE FS antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02254492 KOGENATE FS BIOSET antihemophilic factor B02BD Parenteral Within 1000 (recombinant) /Powder for Guidelines solution

02254476 KOGENATE FS BIOSET antihemophilic factor B02BD Parenteral Within 250 (recombinant) /Powder for Guidelines solution

02451441 KOVALTRY antihemophilic factor B02BD Parenteral Introduced Under Review (recombinant) /Powder for solution

02451468 KOVALTRY antihemophilic factor B02BD Parenteral Introduced Under Review (recombinant) /Powder for solution

02451476 KOVALTRY antihemophilic factor B02BD Parenteral Introduced Under Review (recombinant) /Powder for solution

02451484 KOVALTRY antihemophilic factor B02BD Parenteral Introduced Under Review (recombinant) /Powder for solution

02451492 KOVALTRY antihemophilic factor B02BD Parenteral Introduced Under Review (recombinant) /Powder for solution

02250462 LEVITRA - 5 MG/TAB vardenafil hydrochloride G04BE Oral Solid Does Not /Tablet Trigger

02250470 LEVITRA - 10 MG/TAB vardenafil hydrochloride G04BE Oral Solid Within /Tablet Guidelines

02250489 LEVITRA - 20 MG/TAB vardenafil hydrochloride G04BE Oral Solid Within /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 25

PMPRB Annual Report 2016

02284227 NEXAVAR - sofarenib L01XE Oral Solid Within 200 MG/TAB /Tablet Guidelines

02266121 SATIVEX - delta-9-tetrahydrocannabinol/ N02BG Dental - Within 52 MG/MILLILITER cannabidiol Sublingual Guidelines Buccal /Sprays - Buccal

02372436 STAXYN - vardenafil hydrochloride G04BE Oral Solid Within 10 MG/TAB /Tablet Guidelines

02403390 STIVARGA - regorafenib L01XE Oral Solid Subj. 40 MG/TAB /Tablet Investigation

02316986 XARELTO - rivaroxaban B01AX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02378604 XARELTO - rivaroxaban B01AX Oral Solid Within 15 MG/TAB /Tablet Guidelines

02378612 XARELTO - rivaroxaban B01AX Oral Solid Within 20 MG/TAB /Tablet Guidelines

02441535 XARELTO 15/20 rivaroxaban B01AX Oral Solid Within /Tablet Guidelines

See XOFIGO - 1000 radium ra 223 dichloride V10XX Parenteral Within Note 3 KILOBECQUEREL/ /Solution Guidelines MILLILITER

02261723 YASMIN 21 3/0.03 drospirenone/ethinyl estradiol G03AA Oral Solid Within /Tablet Guidelines

02261731 YASMIN 28 3/0.03 drospirenone/ethinyl estradiol G03AA Oral Solid Within /Tablet Guidelines

02321157 YAZ 28 3/0.02 drospirenone/ ethinyl estradiol G03AA Oral Solid Within /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 26

PMPRB Annual Report 2016

02387433 YAZ PLUS drospirenone/ethinyl G03AA Oral Solid Within estradiol/levomefolate calcium /Tablet Guidelines

BGP Pharma ULC

DIN Brand Name Chemical Name ATC Dosage Comments Status

02249499 ANDROGEL 1% - testosterone G03BA Topical /Gel Within 1.25 G/DOSE Guidelines

02245345 ANDROGEL 1% - testosterone G03BA Topical /Gel Within 2.5 G/POUCH Guidelines

02245346 ANDROGEL 1% - testosterone G03BA Topical /Gel Within 5 G/POUCH Guidelines

02146908 BIAXIN - clarithromycin J01FA Oral Liquid Within 25 MG/MILLILITER /Powder for Guidelines suspension

02244641 BIAXIN - clarithromycin J01FA Oral Liquid Within 50 MG/MILLILITER /Powder for Guidelines suspension

01984853 BIAXIN - clarithromycin J01FA Oral Solid Does Not 250 MG/TAB /Tablet Trigger

02126710 BIAXIN - clarithromycin J01FA Oral Solid Within 500 MG/TAB /Tablet Guidelines

02244756 BIAXIN XL - clarithromycin J01FA Oral Solid Within 500 MG/TAB /Modified Guidelines release tablets

02200104 CREON pancreatin A09AA Oral Solid Under Review MINIMICROSPHERES /Capsule 10 - 10000 UNIT/ CAPSULE

Patented Drug Products for Human Use Reported to the PMPRB in 2016 27

PMPRB Annual Report 2016

01985205 CREON pancreatin A09AA Oral Solid Under Review MINIMICROSPHERES /Capsule 25 - 25000 UNIT/ CAPSULE

02415194 CREON pancreatin A09AA Oral Solid Does Not MINIMICROSPHERES /Capsule Trigger 6 - 6000 UNIT/ CAPSULE

01950592 DICETEL - pinaverium bromide A03AX Oral Solid Within 50 MG/TAB /Tablet Guidelines

02230684 DICETEL - pinaverium bromide A03AX Oral Solid Subj. 100 MG/TAB /Tablet Investigation

02269562 INFLUVAC - influenza vaccine inactivated J07BB Parenteral Within 15 MCG/SYRINGE /Suspensio Guidelines ns or Emulsions

02231457 MAVIK - trandolapril C09AA Oral Solid Does Not 0.5 MG/CAPSULE /Capsule Trigger

02231459 MAVIK - trandolapril C09AA Oral Solid Within 1 MG/CAPSULE /Capsule Guidelines

02231460 MAVIK - trandolapril C09AA Oral Solid Within 2 MG/CAPSULE /Capsule Guidelines

02239267 MAVIK - trandolapril C09AA Oral Solid Subj. 4 MG/CAPSULE /Capsule Investigation

02240946 TARKA 2/240 trandolapril/verapamil C09BB Oral Solid Does Not hydrochloride /Modified Trigger release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 28

PMPRB Annual Report 2016

02238097 TARKA 4/240 trandolapril/verapamil C09BB Oral Solid Does Not hydrochloride /Modified Trigger release tablets

02240432 TEVETEN - eprosartan mesylate C09CA Oral Solid Within 400 MG/TAB /Tablet Guidelines

02243942 TEVETEN - eprosartan mesylate C09CA Oral Solid Subj. 600 MG/TAB /Tablet Investigation

02253631 TEVETEN PLUS eprosatan mesylate/ C09DA Oral Solid Subj. 600/12.5 hydrochlorothiazide /Tablet Investigation

Biogen Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02422913 ALPROLIX - coagulation factor ix B02BD Parenteral Introduced Under Review 500 IU/VIAL (recombinant), fc fusion /Powder for protein solution

02422921 ALPROLIX - coagulation factor ix B02BD Parenteral Introduced Under Review 1000 IU/VIAL (recombinant), fc fusion /Powder for protein solution

02422948 ALPROLIX - coagulation factor ix B02BD Parenteral Introduced Under Review 2000 IU/VIAL (recombinant), fc fusion /Powder for protein solution

02422956 ALPROLIX - coagulation factor ix B02BD Parenteral Introduced Under Review 3000 IU/VIAL (recombinant), fc fusion /Powder for protein solution

02269201 AVONEX PS - interferon beta-1a L03AB Parenteral Does Not 30 MCG/SYRINGE /Solution Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 29

PMPRB Annual Report 2016

02430290 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 250 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430304 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 500 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430312 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 750 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430320 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 1000 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430339 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 1500 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430347 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 2000 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02430355 ELOCTATE - antihemophilic factor B02BD Parenteral Introduced Under Review 3000 IU/VIAL (recombinant bdd), fc fusion /Powder for protein solution

02379910 FAMPYRA - fampridine N07XX Oral Solid Does Not 10 MG/TAB /Modified Trigger release tablets

02444402 PLEGRIDY peginterferon beta-1a L03AB Parenteral Subj. /Solution Investigation

02444399 PLEGRIDY - peginterferon beta-1a L03AB Parenteral Within 125 MCG/SYRINGE /Solution Guidelines

02404508 TECFIDERA - dimethyl fumarate N07XX Oral Solid Subj. 120 MG/CAPSULE /Capsule Investigation

Patented Drug Products for Human Use Reported to the PMPRB in 2016 30

PMPRB Annual Report 2016

02420201 TECFIDERA - dimethyl fumarate N07XX Oral Solid Subj. 240 MG/CAPSULE /Capsule Investigation

02286386 TYSABRI - natalizumab L04AA Parenteral Does Not 20 MG/MILLILITER /Powder for Trigger solution

Biomarin Pharmaceutical Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02350580 KUVAN - sapropterin dihydrochloride A16AX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02412683 NAGLAZYME - galsulfase A16AB Parenteral Within 1 MG/MILLILITER /Solution Guidelines

Biosyent Pharma Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02436639 CYSVIEW - hexaminolevulinate V04CX Parenteral Subj. 100 MG/VIAL hydrochloride /Powder for Investigation solution

Boehringer Ingelheim (Canada) Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02273322 APTIVUS - tipranavir J05AE Oral Solid Within 250 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 31

PMPRB Annual Report 2016

02419106 COMBIVENT ipratropium bromide / R03AL Pulmonary Within RESPIMAT 20/100 salbutamol /Solution Guidelines

02415666 GIOTRIF - afatinib L01XE Oral Solid Within 20 MG/TAB /Tablet Guidelines

02415674 GIOTRIF - afatinib L01XE Oral Solid Within 30 MG/TAB /Tablet Guidelines

02415682 GIOTRIF - afatinib L01XE Oral Solid Within 40 MG/TAB /Tablet Guidelines

02441888 INSPIOLTO tiotropium bromide R03BB Pulmonary Within RESPIMAT 2.5/2.5 monohydrate/olodaterol /Solution Guidelines hydrochloride

02443937 JARDIANCE - empagliflozin A10BX Oral Solid Subj. 10 MG/TAB /Tablet Investigation

02443945 JARDIANCE - empagliflozin A10BX Oral Solid Subj. 25 MG/TAB /Tablet Investigation

02403277 JENTADUETO linagliptin/metforim A10BD Oral Solid Within 2.5/1000 /Tablet Guidelines

02403250 JENTADUETO linagliptin/metforim A10BD Oral Solid Within 2.5/500 /Tablet Guidelines

02403269 JENTADUETO linagliptin/metforim A10BD Oral Solid Within 2.5/850 /Tablet Guidelines

02240769 MICARDIS - telmisartan C09CA Oral Solid Within 40 MG/TAB /Tablet Guidelines

02240770 MICARDIS - telmisartan C09CA Oral Solid Within 80 MG/TAB /Tablet Guidelines

02244344 MICARDIS PLUS telmisartan / C09DA Oral Solid Within 80/12.5 hydrochlorothiazide /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 32

PMPRB Annual Report 2016

02318709 MICARDIS PLUS telmisartan / C09DA Oral Solid Within 80/25 hydrochlorothiazide /Tablet Guidelines

02297256 MIRAPEX - pramipexole dihydrochloride N04BC Oral Solid Within 0.125 MG/TAB /Tablet Guidelines

02237145 MIRAPEX - pramipexole dihydrochloride N04BC Oral Solid Within 0.25 MG/TAB /Tablet Guidelines

02241594 MIRAPEX - pramipexole dihydrochloride N04BC Oral Solid Within 0.5 MG/TAB /Tablet Guidelines

02237146 MIRAPEX - pramipexole dihydrochloride N04BC Oral Solid Within 1 MG/TAB /Tablet Guidelines

02237147 MIRAPEX - pramipexole dihydrochloride N04BC Oral Solid Does Not 1.5 MG/TAB /Tablet Trigger

02443066 OFEV - nintedanib L01XE Oral Solid Subj. 100 MG/CAPSULE /Capsule Investigation

02443074 OFEV - nintedanib L01XE Oral Solid Subj. 150 MG/CAPSULE /Capsule Investigation

02312433 PRADAXA - dabigatran etexilate B01AE Oral Solid Within 75 MG/CAPSULE /Capsule Guidelines

02312441 PRADAXA - dabigatran etexilate B01AE Oral Solid Within 110 MG/CAPSULE /Capsule Guidelines

02358808 PRADAXA - dabigatran etexilate B01AE Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

02246793 SPIRIVA - tiotropium bromide R03BB Pulmonary Within 18 MCG/CAPSULE /Powder Guidelines

02435381 SPIRIVA RESPIMAT - tiotropium bromide R03BB Pulmonary Subj. 2.5 MCG/ monohydrate /Solution Investigation ACTUATION

Patented Drug Products for Human Use Reported to the PMPRB in 2016 33

PMPRB Annual Report 2016

02456621 SYNJARDY empagliflozin/metformin A10BD Oral Solid Introduced Under 12.5/1000 hydrochloride /Tablet Review

02456605 SYNJARDY 12.5/500 empagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02456613 SYNJARDY 12.5/850 empagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02456591 SYNJARDY 5/1000 empagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02456575 SYNJARDY 5/500 empagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02456583 SYNJARDY 5/850 empagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02370921 TRAJENTA - linagliptin A10BH Oral Solid Within 5 MG/TAB /Tablet Guidelines

02371030 TWYNSTA 40/10 telmisartan/amlodipine C09DB Oral Solid Within besylate /Tablet Guidelines

02371022 TWYNSTA 40/5 telmisartan/amlodipine C09DB Oral Solid Within besylate /Tablet Guidelines

02371057 TWYNSTA 80/10 telmisartan/amlodipine C09DB Oral Solid Within besylate /Tablet Guidelines

02371049 TWYNSTA 80/5 telmisartan/amlodipine C09DB Oral Solid Within besylate /Tablet Guidelines

02367289 VIRAMUNE XR - nevirapine J05AG Oral Solid Within 400 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 34

PMPRB Annual Report 2016

Bracco Diagnostics Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02248302 MULTIHANCE - gadobenate dimeglumine V08CA Parenteral Within 529 MG/MILLILITER /Solution Guidelines

02229056 PROHANCE - gadoteridol V08CA Parenteral Within 279.3 MG/MILLILITER /Solution Guidelines

Bristol-Myers Squibb Canada Co.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02322374 ABILIFY - aripiprazole N05AX Oral Solid Within 2 MG/TAB /Tablet Guidelines

02322382 ABILIFY - aripiprazole N05AX Oral Solid Within 5 MG/TAB /Tablet Guidelines

02322390 ABILIFY - aripiprazole N05AX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02322404 ABILIFY - aripiprazole N05AX Oral Solid Within 15 MG/TAB /Tablet Guidelines

02322412 ABILIFY - aripiprazole N05AX Oral Solid Within 20 MG/TAB /Tablet Guidelines

02322455 ABILIFY - aripiprazole N05AX Oral Solid Within 30 MG/TAB /Tablet Guidelines

02282224 BARACLUDE - entecavir J05AF Oral Solid Within 0.5 MG/TAB /Tablet Guidelines

02444747 DAKLINZA - daclatasvir J05AX Oral Solid Within 30 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 35

PMPRB Annual Report 2016

02444755 DAKLINZA - daclatasvir J05AX Oral Solid Within 60 MG/TAB /Tablet Guidelines

02377233 ELIQUIS - apixaban B01AF Oral Solid Within 2.5 MG/TAB /Tablet Guidelines

02397714 ELIQUIS - apixaban B01AF Oral Solid Within 5 MG/TAB /Tablet Guidelines

02446731 EVOTAZ - atazanavir sulphate/ cobicistat J05AR Oral Solid Introduced Within 450 MG/TAB /Tablet Guidelines

02282097 ORENCIA - abatacept L04AA Parenteral Within 250 MG/VIAL /Powder for Guidelines solution

02402475 ORENCIA - abatacept L04AA Parenteral Within 125 MG/SYRINGE /Solution Guidelines

02248610 REYATAZ - atazanavir sulfate J05AE Oral Solid Does Not 150 MG/CAPSULE /Capsule Trigger

02248611 REYATAZ - atazanavir sulfate J05AE Oral Solid Does Not 200 MG/CAPSULE /Capsule Trigger

02294176 REYATAZ - atazanavir sulfate J05AE Oral Solid Within 300 MG/CAPSULE /Capsule Guidelines

02293129 SPRYCEL - dasatinib L01XE Oral Solid Within 20 MG/TAB /Tablet Guidelines

02293137 SPRYCEL - dasatinib L01XE Oral Solid Does Not 50 MG/TAB /Tablet Trigger

02293145 SPRYCEL - dasatinib L01XE Oral Solid Does Not 70 MG/TAB /Tablet Trigger

02360810 SPRYCEL - dasatinib L01XE Oral Solid Does Not 80 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 36

PMPRB Annual Report 2016

02320193 SPRYCEL - dasatinib L01XE Oral Solid Within 100 MG/TAB /Tablet Guidelines

02360829 SPRYCEL - dasatinib L01XE Oral Solid Does Not 140 MG/TAB /Tablet Trigger

02452294 SUNVEPRA - asunaprevir J05AE Oral Solid Introduced Under 100 MG/CAPSULE /Capsule Review

02239886 SUSTIVA - efavirenz J05AG Oral Solid Does Not 50 MG/CAPSULE /Capsule Trigger

02239888 SUSTIVA - efavirenz J05AG Oral Solid Within 200 MG/CAPSULE /Capsule Guidelines

02246045 SUSTIVA - efavirenz J05AG Oral Solid Within 600 MG/TAB /Tablet Guidelines

02379384 YERVOY - ipilimumab L01XC Parenteral Within 5 MG/MILLILITER /Solution Guidelines

Celgene Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02281066 ABRAXANE - nanoparticle albumin-bound L01CD Parenteral Within 100 MG/VIAL paclitaxel /Suspensio Guidelines ns or Emulsions

02419580 POMALYST - pomalidomide L04AX Oral Solid Within 1 MG/CAPSULE /Capsule Guidelines

02419599 POMALYST - pomalidomide L04AX Oral Solid Within 2 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 37

PMPRB Annual Report 2016

02419602 POMALYST - pomalidomide L04AX Oral Solid Within 3 MG/CAPSULE /Capsule Guidelines

02419610 POMALYST - pomalidomide L04AX Oral Solid Within 4 MG/CAPSULE /Capsule Guidelines

02304899 REVLIMID - lenalidomide L04AX Oral Solid Subj. 5 MG/CAPSULE /Capsule Investigation

02304902 REVLIMID - 10 lenalidomide L04AX Oral Solid Subj. MG/CAPSULE /Capsule Investigation

02317699 REVLIMID - 15 lenalidomide L04AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02440601 REVLIMID - 20 lenalidomide L04AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02317710 REVLIMID - 25 lenalidomide L04AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02355191 THALOMID - thalidomide L04AX Oral Solid VCU 50 MG/CAPSULE /Capsule

02355205 THALOMID - thalidomide L04AX Oral Solid VCU 100 MG/CAPSULE /Capsule

02355221 THALOMID - thalidomide L04AX Oral Solid VCU 200 MG/CAPSULE /Capsule

Cipher Pharmaceuticals Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02449773 BETEFLAM - betamethasone valerate D07AC Topical Introduced Subj. 2.25 MG/PATCH /Patches Investigation

Patented Drug Products for Human Use Reported to the PMPRB in 2016 38

PMPRB Annual Report 2016

Correvio (UK) Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02240706 AGGRASTAT - tirofiban hydrochloride B01AC Parenteral Expired Subj. 0.05 MG/MILLILITER /Solution Investigation

CSL Behring Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02418738 CORIFACT - factor xiii concentrate, human B02BD Parenteral Under Review 250 IU/MILLILITER /Powder for solution

02418746 CORIFACT - factor xiii concentrate, human B02BD Parenteral Under Review 1250 IU/MILLILITER /Powder for solution

FIBROGAMMIN factor xiii (human) B02BD Parenteral Subj. 250/1250 /Powder for Investigation solution

02370352 HIZENTRA - subcutaneous immune globulin J06BA Parenteral Subj. 200 MG/MILLILITER (human) /Solution Investigation

02304619 PRIVIGEN - immune globulin intravenous J06BA Parenteral Subj. 100 MG/MILLILITER (human) /Solution Investigation

Duchesnay Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

00609129 DICLECTIN 10/10 doxylamine R06AA Oral Solid Within succinate/pyridoxine /Modified Guidelines hydrochloride release

Patented Drug Products for Human Use Reported to the PMPRB in 2016 39

PMPRB Annual Report 2016

tablets

02451573 PREGVIT multivitamin-minerals B03AE Oral Solid Introduced Under /Tablet Review

02246067 PREGVIT multivitamins-minerals B03AE Oral Solid Within /Tablet Guidelines

02451581 PREGVIT FOLIC 5 multivitamins-minerals B03AE Oral Solid Introduced Under /Tablet Review

02276194 PREGVIT FOLIC 5 multivitamins-minerals B03AE Oral Solid Does Not /Tablet Trigger

Eisai Limited

DIN Brand Name Chemical Name ATC Dosage Comments Status

02381729 ALOXI - palonosetron hydrochloride A04AA Oral Solid Within 0.5 MG/CAPSULE /Capsule Guidelines

02381710 ALOXI - palonosetron hydrochloride A04AA Parenteral Within 0.05 MG/MILLILITER /Solution Guidelines

02369613 BANZEL - rufinamide N03AF Oral Solid Within 100 MG/TAB /Tablet Guidelines

02369621 BANZEL - rufinamide N03AF Oral Solid Within 200 MG/TAB /Tablet Guidelines

02369648 BANZEL - rufinamide N03AF Oral Solid Within 400 MG/TAB /Tablet Guidelines

02404516 FYCOMPA - perampanel N03AX Oral Solid Within 2 MG/TAB /Tablet Guidelines

02404524 FYCOMPA - perampanel N03AX Oral Solid Within

Patented Drug Products for Human Use Reported to the PMPRB in 2016 40

PMPRB Annual Report 2016

4 MG/TAB /Tablet Guidelines

02404532 FYCOMPA - perampanel N03AX Oral Solid Within 6 MG/TAB /Tablet Guidelines

02404540 FYCOMPA - perampanel N03AX Oral Solid Within 8 MG/TAB /Tablet Guidelines

02404559 FYCOMPA - perampanel N03AX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02404567 FYCOMPA - perampanel N03AX Oral Solid Within 12 MG/TAB /Tablet Guidelines

02377438 HALAVEN - eribulin mesylate L01XX Parenteral Within 1 MG/MILLILITER /Solution Guidelines

02450321 LENVIMA - lenvatinib L01XE Oral Solid Introduced Under 10 MG/DAY /Capsule Review

02450305 LENVIMA 10/10 lenvatinib mesylate L01XE Oral Solid Introduced Within /Capsule Guidelines

02450291 LENVIMA 10/10/4 lenvatinib mesylate L01XE Oral Solid Introduced Within /Capsule Guidelines

02450313 LENVIMA 10/4 lenvatinib mesylate L01XE Oral Solid Introduced Within /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 41

PMPRB Annual Report 2016

Eli Lilly Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02338327 ADCIRCA - tadalafil C02KX Oral Solid Subj. 20 MG/TAB /Tablet Investigation

02306433 ALIMTA - pemetrexed sodium L01BA Parenteral Within 100 MG/VIAL /Powder for Guidelines solution

02253437 ALIMTA - pemetrexed sodium L01BA Parenteral Within 500 MG/VIAL /Powder for Guidelines solution

02382369 AXIRON - testosterone topical G03BA Topical Within 30 MG/DOSE solution, 2% /Liquid Guidelines

02296888 CIALIS - 2.5 MG/TAB tadalafil G04BE Oral Solid VCU /Tablet

02296896 CIALIS - 5 MG/TAB tadalafil G04BE Oral Solid VCU /Tablet

02248088 CIALIS - 10 MG/TAB tadalafil G04BE Oral Solid VCU /Tablet

02248089 CIALIS - 20 MG/TAB tadalafil G04BE Oral Solid VCU /Tablet

02301482 CYMBALTA - duloxetine hydrochloride N06AX Oral Solid Within 30 MG/CAPSULE /Modified Guidelines release capsules

02301490 CYMBALTA - duloxetine hydrochloride N06AX Oral Solid Within 60 MG/CAPSULE /Modified Guidelines release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 42

PMPRB Annual Report 2016

02443805 CYRAMZA - ramucirumab L01XC Parenteral Subj. 10 MG/MILLILITER /Solution Investigation

02349124 EFFIENT - 10 MG/TAB prasugrel hydrochloride B01AC Oral Solid Subj. /Tablet Investigation

02271249 ERBITUX - cetuximab L01XC Parenteral Expired Does Not 100 MG/VIAL /Solution Trigger

02254689 FORTEO - teriparatide (rdna origin) H05AA Parenteral Does Not 600 MCG/CARTRIDGE /Solution Trigger

02229704 HUMALOG - insulin lispro A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02229705 HUMALOG - insulin lispro A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02403412 HUMALOG KWIKPEN insulin lispro A10AB Parenteral Within - 100 UNIT/ /Solution Guidelines MILLILITER

02439611 HUMALOG KWIKPEN insulin lispro A10AB Parenteral Within - 200 UNIT/ /Solution Guidelines MILLILITER

02403420 HUMALOG MIX 25 insulin lispro A10AB Parenteral Within KWIKPEN - 100 UNIT/ /Solution Guidelines MILLILITER

02240294 HUMALOG MIX 25/75 insulin (lispro/lispro A10AB Parenteral Does Not protamine) /Solution Trigger

02403439 HUMALOG MIX 50 insulin lispro A10AB Parenteral Does Not KWIKPEN - 100 UNIT/ /Solution Trigger MILLILITER

02240297 HUMALOG MIX 50/50 insulin (lispro/lispro A10AB Parenteral Within protamine) /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 43

PMPRB Annual Report 2016

02018985 PROZAC - fluoxetine hydrochloride N06AB Oral Solid Within 10 MG/CAPSULE /Capsule Guidelines

00636622 PROZAC - fluoxetine hydrochloride N06AB Oral Solid Within 20 MG/CAPSULE /Capsule Guidelines

02216973 REOPRO - abciximab B01AC Parenteral Does Not 2 MG/MILLILITER /Solution Trigger

02262800 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 10 MG/CAPSULE /Capsule Guidelines

02262819 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 18 MG/CAPSULE /Capsule Guidelines

02262827 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 25 MG/CAPSULE /Capsule Guidelines

02262835 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 40 MG/CAPSULE /Capsule Guidelines

02262843 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 60 MG/CAPSULE /Capsule Guidelines

02279347 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 80 MG/CAPSULE /Capsule Guidelines

02279355 STRATTERA - atomoxetine hydrochloride N06BA Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

02455102 TALTZ - ixekizumab L04AC Parenteral Introduced Under Review 80 MG/MILLILITER /Solution

02455110 TALTZ - ixekizumab L04AC Parenteral Introduced Under Review 80 MG/MILLILITER /Solution

02448599 TRULICITY - dulaglutide A10BX Parenteral Introduced Within 0.75 MG/PEN /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 44

PMPRB Annual Report 2016

02448602 TRULICITY - dulaglutide A10BX Parenteral Within 1.5 MG/PEN /Solution Guidelines

02229250 ZYPREXA - olanzapine N05AH Oral Solid Within 2.5 MG/TAB /Tablet Guidelines

02229269 ZYPREXA - olanzapine N05AH Oral Solid Within 5 MG/TAB /Tablet Guidelines

02229277 ZYPREXA - olanzapine N05AH Oral Solid Within 7.5 MG/TAB /Tablet Guidelines

02229285 ZYPREXA - olanzapine N05AH Oral Solid Within 10 MG/TAB /Tablet Guidelines

02238850 ZYPREXA - olanzapine N05AH Oral Solid Within 15 MG/TAB /Tablet Guidelines

02238851 ZYPREXA - olanzapine N05AH Oral Solid Within 20 MG/TAB /Tablet Guidelines

02247099 ZYPREXA olanzapine N05AH Parenteral Within INTRAMUSCULAR - /Powder for Guidelines 10 MG/VIAL solution

02243086 ZYPREXA ZYDIS - olanzapine N05AH Oral Solid Within 5 MG/TAB /Tablet Guidelines

02243087 ZYPREXA ZYDIS - olanzapine N05AH Oral Solid Within 10 MG/TAB /Tablet Guidelines

02243088 ZYPREXA ZYDIS - olanzapine N05AH Oral Solid Within 15 MG/TAB /Tablet Guidelines

02243089 ZYPREXA ZYDIS - olanzapine N05AH Oral Solid Within 20 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 45

PMPRB Annual Report 2016

EMD Serono Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02247766 CETROTIDE - cetrorelix H01CC Parenteral Within 0.25 MG/VIAL /Powder Guidelines for solution

02248157 GONAL-F - follitropin alpha G03GA Parenteral Within 75 UNIT/VIAL /Powder Guidelines for solution

02248156 GONAL-F - follitropin alpha G03GA Parenteral Within 75 UNIT/VIAL /Powder Guidelines for solution

02248154 GONAL-F - follitropin alpha G03GA Parenteral Within 75 UNIT/VIAL /Powder Guidelines for solution

02270404 GONAL-F PEN - follitropin alpha G03GA Parenteral Within 300 UNIT/PEN /Solution Guidelines

02270390 GONAL-F PEN - follitropin alpha G03GA Parenteral Within 450 UNIT/PEN /Solution Guidelines

02270382 GONAL-F PEN - follitropin alpha G03GA Parenteral Within 900 UNIT/PEN /Solution Guidelines

02269066 LUVERIS - lutropin alpha G03GA Parenteral Does Not 75 UNIT/VIAL /Powder Trigger for solution

02445301 PERGOVERIS follitropin alfa/lutropin alfa G03GA Oral Liquid VCU 150/75 - 225 /Powder UNIT/KIT for solution

02350122 SAIZEN LIQUID - somatropin H01AC Parenteral Within 6 MG/CARTRIDGE /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 46

PMPRB Annual Report 2016

02350130 SAIZEN LIQUID - somatropin H01AC Parenteral Within 12 MG/CARTRIDGE /Solution Guidelines

02350149 SAIZEN LIQUID - somatropin H01AC Parenteral Within 20 MG/CARTRIDGE /Solution Guidelines

Ferring Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02455889 CORTIMENT - budesonide A07EA Oral Solid Introduced Under 9 MG/TAB /Tablet Review

00824305 DDAVP - desmopressin acetate H01BA Oral Solid Within 0.1 MG/TAB /Tablet Guidelines

00824143 DDAVP - desmopressin acetate H01BA Oral Solid Within 0.2 MG/TAB /Tablet Guidelines

02284995 DDAVP MELT - desmopressin acetate H01BA Oral Solid Within 60 MCG/TAB /Tablet Guidelines

02285002 DDAVP MELT - desmopressin acetate H01BA Oral Solid Within 120 MCG/TAB /Tablet Guidelines

02285010 DDAVP MELT - desmopressin acetate H01BA Oral Solid Within 240 MCG/TAB /Tablet Guidelines

02334992 ENDOMETRIN - progesterone G03DA Vaginal Within 100 MG/TAB /Tablet Guidelines

02337029 FIRMAGON - degarelix acetate L02BX Parenteral Does Not 80 MG/VIAL /Powder for Trigger solution

02337037 FIRMAGON - degarelix acetate L02BX Parenteral Does Not 120 MG/VIAL /Powder for Trigger solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 47

PMPRB Annual Report 2016

02246500 MINIRIN - desmopressin acetate H01BA Oral Solid Does Not 0.1 MG/TAB /Tablet Trigger

02431076 NOCDURNA - desmopressin acetate H01BA Dental - Does Not 50 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02397927 NOCDURNA - desmopressin acetate H01BA Oral Solid Does Not 25 MCG/TAB /Tablet Trigger

02399466 PENTASA - mesalamine A07EC Oral Solid Within 1 GM/TAB /Tablet Guidelines

02099683 PENTASA - mesalamine A07EC Oral Solid Subj. 500 MG/TAB /Tablet Investigation

Fournier Pharma Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02269074 LIPIDIL EZ - fenofibrate C10AB Oral Solid Within 48 MG/TAB /Tablet Guidelines

02269082 LIPIDIL EZ - fenofibrate C10AB Oral Solid Within 145 MG/TAB /Tablet Guidelines

02146959 LIPIDIL MICRO - fenofibrate C10AB Oral Solid Does Not 200 MG/CAPSULE /Capsule Trigger

02241602 LIPIDIL SUPRA - fenofibrate C10AB Oral Solid Within 160 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 48

PMPRB Annual Report 2016

Galderma Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02375885 APPRILON - doxycycline monohydrate J01AA Oral Solid Does Not 40 MG/CAPSULE /Modified Trigger release capsules

02274000 DIFFERIN XP - adapalene D10AD Topical /Gel Expired Does Not 3 MG/GRAM Trigger

02297809 METROGEL - metronidazole topical gel D06BX Topical /Gel Expired Within 10 MG/GRAM galderma std, 1% Guidelines

02323273 METVIX - methyl aminolevulinate L01XD Topical Within 168 MG/GRAM hydrochloride /Cream Guidelines

02421208 ONRELTEA - brimonidine, 0.33% S01EA Topical /Gel Subj. 5 MG/GRAM Investigation

02398028 PLIAGLIS 70/70 lidocaine 7% / tetracaine 7% N01BB Topical Subj. /Cream Investigation

02440342 ROSIVER - ivermectin D11AX Topical Within 10 MG/GRAM /Cream Guidelines

02365871 TACTUPUMP 1/25 adapalene 0.1%/benzoyl D10AD Topical /Gel Does Not peroxide 2.5% Trigger

02446235 TACTUPUMP adapalene 0.3%/benzoyl D10AD Topical /Gel Introduced Under FORTE - peroxide 2.5% Review 70 G/PUMP

Patented Drug Products for Human Use Reported to the PMPRB in 2016 49

PMPRB Annual Report 2016

GENMED, A Division Of Pfizer Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02280132 GD-AMLODIPINE - amlodipine besylate C08CA Oral Solid See Note 1 5 MG/TAB /Tablet in 2016 Annual Report

02280140 GD-AMLODIPINE - amlodipine besylate C08CA Oral Solid See Note 1 10 MG/TAB /Tablet in 2016 Annual Report

02362791 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 10/10 atrovastatin calcium /Tablet in 2016 Annual Report

02362805 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 10/20 atrovastatin calcium /Tablet in 2016 Annual Report

02362813 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 10/40 atrovastatin calcium /Tablet in 2016 Annual Report

02362821 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 10/80 atrovastatin calcium /Tablet in 2016 Annual Report

02362759 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 5/10 atorvastatin calcium /Tablet in 2016 Annual Report

Patented Drug Products for Human Use Reported to the PMPRB in 2016 50

PMPRB Annual Report 2016

02362767 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 5/20 atrovastatin calcium /Tablet in 2016 Annual Report

02362775 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 5/40 atrovastatin calcium /Tablet in 2016 Annual Report

02362783 GD-AMLODIPINE/ amlodipine besylate/ C10BX Oral Solid See Note 1 ATORVASTATIN 5/80 atrovastatin calcium /Tablet in 2016 Annual Report

02288346 GD-ATORVASTATIN - atorvastatin calcium C10AA Oral Solid See Note 1 10 MG/TAB /Tablet in 2016 Annual Report

02288354 GD-ATORVASTATIN - atorvastatin calcium C10AA Oral Solid See Note 1 20 MG/TAB /Tablet in 2016 Annual Report

02288362 GD-ATORVASTATIN - atorvastatin calcium C10AA Oral Solid See Note 1 40 MG/TAB /Tablet in 2016 Annual Report

02288370 GD-ATORVASTATIN - atorvastatin calcium C10AA Oral Solid See Note 1 80 MG/TAB /Tablet in 2016 Annual Report

02274566 GD-AZITHROMYCIN - azithromycin J01FA Oral Liquid See Note 1 20 MG/MILLILITER /Powder in 2016 for Annual suspension Report

Patented Drug Products for Human Use Reported to the PMPRB in 2016 51

PMPRB Annual Report 2016

02274574 GD-AZITHROMYCIN - azithromycin J01FA Oral Liquid See Note 1 40 MG/MILLILITER /Powder in 2016 for Annual suspension Report

02274531 GD-AZITHROMYCIN - azithromycin J01FA Oral Solid See Note 1 250 MG/TAB /Tablet in 2016 Annual Report

02291975 GD-CELECOXIB - celecoxib L01XX Oral Solid See Note 1 100 MG/CAPSULE /Capsule in 2016 Annual Report

02291983 GD-CELECOXIB - celecoxib L01XX Oral Solid See Note 1 200 MG/CAPSULE /Capsule in 2016 Annual Report

02285819 GD-GABAPENTIN - gabapentin N03AX Oral Solid See Note 1 100 MG/CAPSULE /Capsule in 2016 Annual Report

02285827 GD-GABAPENTIN - gabapentin N03AX Oral Solid See Note 1 300 MG/CAPSULE /Capsule in 2016 Annual Report

02285835 GD-GABAPENTIN - gabapentin N03AX Oral Solid See Note 1 400 MG/CAPSULE /Capsule in 2016 Annual Report

02285843 GD-GABAPENTIN - gabapentin N03AX Oral Solid See Note 1 600 MG/TAB /Tablet in 2016 Annual Report

Patented Drug Products for Human Use Reported to the PMPRB in 2016 52

PMPRB Annual Report 2016

02285851 GD-GABAPENTIN - gabapentin N03AX Oral Solid See Note 1 800 MG/TAB /Tablet in 2016 Annual Report

02290987 GD-QUINAPRIL - quinapril hydrochloride C09AA Oral Solid See Note 1 5 MG/TAB /Tablet in 2016 Annual Report

02290995 GD-QUINAPRIL - quinapril hydrochloride C09AA Oral Solid See Note 1 10 MG/TAB /Tablet in 2016 Annual Report

02291002 GD-QUINAPRIL - quinapril hydrochloride C09AA Oral Solid See Note 1 20 MG/TAB /Tablet in 2016 Annual Report

02291010 GD-QUINAPRIL - quinapril hydrochloride C09AA Oral Solid See Note 1 40 MG/TAB /Tablet in 2016 Annual Report

02291991 GD-SILDENAFIL - sildenafil citrate G04BE Oral Solid See Note 1 25 MG/TAB /Tablet in 2016 Annual Report

02292009 GD-SILDENAFIL - sildenafil citrate G04BE Oral Solid See Note 1 50 MG/TAB /Tablet in 2016 Annual Report

02292017 GD-SILDENAFIL - sildenafil citrate G04BE Oral Solid See Note 1 100 MG/TAB /Tablet in 2016 Annual Report

Patented Drug Products for Human Use Reported to the PMPRB in 2016 53

PMPRB Annual Report 2016

02360020 GD-VENLAFAXINE XR - venlafaxine N06AA Oral Solid See Note 1 37.5 MG/CAPSULE hydrochloride /Modified in 2016 release Annual capsules Report

02360039 GD-VENLAFAXINE XR - venlafaxine N06AA Oral Solid See Note 1 75 MG/CAPSULE hydrochloride /Modified in 2016 release Annual capsules Report

02360047 GD-VENLAFAXINE XR - venlafaxine N06AA Oral Solid See Note 1 150 MG/CAPSULE hydrochloride /Modified in 2016 release Annual capsules Report

Gilead Sciences Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02300699 ATRIPLA efavirenz / emtricitabine / J05AR Oral Solid Within 600/200/300 tenofovir disoproxil fumarate /Tablet Guidelines

02329840 CAYSTON - aztreonam J01DF Pulmonary Subj. 75 MG/VIAL /Powder Investigation

02374129 COMPLERA emtricitabine/tenofovir J05AR Oral Solid Within 200/300/25 df/rilpivirine hcl /Tablet Guidelines

02454416 DESCOVY 200/10 emtricitabine/tenofovir J05AR Oral Solid Introduced Under Review alafenamide /Tablet

02454424 DESCOVY 200/25 emtricitabine/tenofovir J05AR Oral Solid Introduced Under Review alafenamide /Tablet

02456370 EPCLUSA 400/100 sofosbuvir/velpatasvir J05AX Oral Solid Introduced Within /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 54

PMPRB Annual Report 2016

02449498 GENVOYA elvitegravir/cobicistat/emtricit J05AR Oral Solid Introduced Subj. 200/150/150/10 abine/tenofovir alafenamide /Tablet Investigation

02432226 HARVONI 90/400 ledipasvir/sofosbuvir J05AX Oral Solid Within /Tablet Guidelines

02247823 HEPSERA - adefovir dipivoxil J05AF Oral Solid Within 10 MG/TAB /Tablet Guidelines

02418355 SOVALDI - sofosbuvir J05AX Oral Solid Within 400 MG/TAB /Tablet Guidelines

02397137 STRIBILD elvitegravir/cobicistat/ J05AR Oral Solid Within 150/150/200/300 emtricitabine/tenofovir /Tablet Guidelines disproxil fumarate

02274906 TRUVADA 200/300 emtricitabine/tenofovir J05AR Oral Solid Subj. disoproxil fumarate /Tablet Investigation

02247128 VIREAD - tenofovir disoproxil fumarate J05AF Oral Solid Within 300 MG/TAB /Tablet Guidelines

02438798 ZYDELIG - idelalisib L01XX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02438801 ZYDELIG - idelalisib L01XX Oral Solid Within 150 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 55

PMPRB Annual Report 2016

Glaxosmithkline Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02245126 ADVAIR 25/125 salmeterol R03AK Pulmonary Within xinafoate/fluticasone /Metered Guidelines propionate dose preparations

02245127 ADVAIR 25/250 salmeterol R03AK Pulmonary Within xinafoate/fluticasone /Metered Guidelines propionate dose preparations

02240835 ADVAIR 50/100 salmeterol R03AK Pulmonary Within DISKUS xinafoate/fluticasone /Powder Guidelines propionate

02240836 ADVAIR 50/250 salmeterol R03AK Pulmonary Within DISKUS xinafoate/fluticasone /Powder Guidelines propionate

02240837 ADVAIR 50/500 salmeterol R03AK Pulmonary Within DISKUS xinafoate/fluticasone /Powder Guidelines propionate

02418401 ANORO ELLIPTA umeclidinium R03AL Pulmonary Within 62.5/25 bromide/vilanterol /Powder Guidelines

02446561 ARNUITY ELLIPTA - fluticasone furoate R01AD Pulmonary Introduced Within 100 MCG/DOSE /Powder Guidelines

02446588 ARNUITY ELLIPTA - fluticasone furoate R01AD Pulmonary Introduced Within 200 MCG/DOSE /Powder Guidelines

02298589 AVAMYS - fluticasone furoate R01AD Nasal /Spray Within 27.5 MCG/DOSE Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 56

PMPRB Annual Report 2016

02248440 AVANDAMET 2/1000 rosiglitazone A10BD Oral Solid Within maleate/metformin /Tablet Guidelines hydrochloride

02247086 AVANDAMET 2/500 rosiglitazone A10BD Oral Solid Does Not maleate/metformin /Tablet Trigger hydrochloride

02248441 AVANDAMET 4/1000 rosiglitazone A10BD Oral Solid Within maleate/metformin /Tablet Guidelines hydrochloride

02247087 AVANDAMET 4/500 rosiglitazone A10BD Oral Solid Within maleate/metformin /Tablet Guidelines hydrochloride

02241112 AVANDIA - 2 MG/TAB rosiglitazone maleate A10BG Oral Solid Within /Tablet Guidelines

02241113 AVANDIA - 4 MG/TAB rosiglitazone maleate A10BG Oral Solid Within /Tablet Guidelines

02241114 AVANDIA - rosiglitazone maleate A10BG Oral Solid Within 8 MG/TAB /Tablet Guidelines

02370050 BENLYSTA - belimumab L04AA Parenteral Does Not 120 MG/VIAL /Powder for Trigger solution

02370069 BENLYSTA - belimumab L04AA Parenteral Does Not 400 MG/VIAL /Powder for Trigger solution

02417030 BEXSERO multicomponent J07AH Parenteral Subj. meningococcal b vaccine /Suspensions Investigation or Emulsions

02247600 BOOSTRIX combined diphtheria, J07AX Parenteral Subj. tetanus, acellular pertussis /Suspensions Investigation (adsorbed) vaccine for or Emulsions booster vaccination

Patented Drug Products for Human Use Reported to the PMPRB in 2016 57

PMPRB Annual Report 2016

02312557 BOOSTRIX POLIO combined diphtheria, J07CA Parenteral VCU tetanus, acellular pertussis /Suspensions (adsorbed) and inactivated or Emulsions poliomyelitis

02408872 BREO ELLIPTA 100/25 fluticasone furoate/ R03AK Pulmonary Within vilanterol /Powder Guidelines

02444186 BREO ELLIPTA 200/25 fluticasone furoate/vilanterol R03AK Pulmonary Within /Powder Guidelines

02212307 CEFTIN - cefuroxime axetil J01DC Oral Liquid Within 25 MG/MILLILITER /Powder for Guidelines suspension

02212277 CEFTIN - cefuroxime axetil J01DC Oral Solid VCU 250 MG/TAB /Tablet

02212285 CEFTIN - cefuroxime axetil J01DC Oral Solid VCU 500 MG/TAB /Tablet

02342227 CERVARIX human papillomavirus J07BM Parenteral Does Not vaccine types 16 and 18 /Suspensions Trigger (recombinant, as04 or Emulsions adjuvanted)

01916882 CLAVULIN 25/6.25 amoxicillin:clavulanic acid J01CR Oral Liquid Does Not /Suspension Trigger

02238831 CLAVULIN 40/5.7 amoxicillin:clavulanic acid J01CR Oral Liquid Does Not /Suspension Trigger

01916874 CLAVULIN 50/12.5 amoxicillin:clavulanic acid J01CR Oral Liquid Subj. /Suspension Investigation

01916858 CLAVULIN 500/125 amoxicillin:clavulanic acid J01CR Oral Solid Within /Tablet Guidelines

02238830 CLAVULIN 80/11.4 amoxicillin:clavulanic acid J01CR Oral Liquid Within /Suspension Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 58

PMPRB Annual Report 2016

02238829 CLAVULIN 875/125 amoxicillin:clavulanic acid J01CR Oral Solid Does Not /Tablet Trigger

02243050 CLINDETS - clindamycin phosphate D10AF Topical VCU 0.01 MG/MILLILITER /Other

02382822 CLINDOXYL clindamycin/ benzoyl D10AF Topical /Gel Subj. ADV GEL 10/30 peroxide Investigation

02243158 CLINDOXYL clindamycin/ benzoyl D10AF Topical /Gel Within GEL 10/50 peroxide Guidelines

00068608 COACTIFED - triprolidine hcl – R05DA Oral Solid VCU 20 MG/TAB pseudoephedrine hcl – /Tablet codeine phosphate

00068594 COACTIFED SYRUP - triprolidine hcl – R05DA Oral Liquid VCU 10 MG/DOSE pseudoephedrine hcl – /Solution codeine phosphate

02192284 CYCLOCORT CREAM - amcinonide D07AC Topical VCU 1 MG/GRAM /Cream

02192276 CYCLOCORT LOTION - amcinonide D07AC Topical VCU 0.001 MG/MILLILITER /Liquid

02192268 CYCLOCORT amcinonide D07AC Topical VCU OINTMENT - /Ointment 1 MG/GRAM

00192597 EMO CORT CREAM - hydrocortisone A01AC Topical VCU 10 MG/GRAM /Cream

00595799 EMO CORT CREAM - hydrocortisone A01AC Topical VCU 25 MG/GRAM /Cream

00192600 EMO CORT LOTION - hydrocortisone A01AC Topical VCU 0.01 MG/MILLILITER /Liquid

Patented Drug Products for Human Use Reported to the PMPRB in 2016 59

PMPRB Annual Report 2016

00595802 EMO CORT LOTION - hydrocortisone A01AC Topical VCU 0.025 MG/MILLILITER /Liquid

01919431 ENGERIX-B hepatitis b vaccine (rdna) J07BC Parenteral Subj. /Suspensions Investigation or Emulsions

02296454 ENGERIX-B PEDIATRIC hepatitis b vaccine J07BC Parenteral Subj. (recombinant) /Suspensions Investigation or Emulsions

02213672 FLONASE - fluticasone propionate R01AD Nasal /Spray VCU 50 MCG/DOSE

02237245 FLOVENT DISKUS - fluticasone propionate R03BA Pulmonary Within 0.1 MG/DOSE /Powder Guidelines

02237246 FLOVENT DISKUS - fluticasone propionate R03BA Pulmonary Within 0.25 MG/DOSE /Powder Guidelines

02237247 FLOVENT DISKUS - fluticasone propionate R03BA Pulmonary Within 0.5 MG/DOSE /Powder Guidelines

02244291 FLOVENT HFA - fluticasone propionate R03BA Pulmonary Within 0.05 MG/DOSE /Metered Guidelines dose preparations

02244292 FLOVENT HFA - fluticasone propionate R03BA Pulmonary Within 0.125 MG/DOSE /Metered Guidelines dose preparations

02244293 FLOVENT HFA - fluticasone propionate R03BA Pulmonary Within 0.25 MG/DOSE /Metered Guidelines dose preparations

02420783 FLULAVAL TETRA - quadrivalent influenza J07BB Parenteral Within 15 UNIT/DOSE vaccine (inactivated, split- /Suspensions Guidelines virion) or Emulsions

Patented Drug Products for Human Use Reported to the PMPRB in 2016 60

PMPRB Annual Report 2016

02420686 FLUVIRAL influenza virus vaccine J07BB Parenteral VCU trivalent, inactivated split- /Suspensions virion or Emulsions

02187078 HAVRIX 1440 - hepatitis a vaccine, J07BC Parenteral Subj. 1440 UNIT/ inactivated /Suspensions Investigation MILLILITER or Emulsions

02231056 HAVRIX 720 JUNIOR - hepatitis a vaccine, J07BC Parenteral Subj. 1440 UNIT/ inactivated /Suspensions Investigation MILLILITER or Emulsions

02239194 HEPTOVIR - lamivudine J05AF Oral Liquid Does Not 5 MG/MILLILITER /Solution Trigger

02239193 HEPTOVIR - lamivudine J05AF Oral Solid Within 100 MG/TAB /Tablet Guidelines

02239200 HIBERIX haemophilus influenzae type J07AG Parenteral VCU b (hib) conjugate /Powder for vaccine(tetanus protein – solution conjugate)

02230418 IMITREX - sumatriptan hemisulphate N02CC Nasal /Spray Does Not 5 MG/DOSE Trigger

02230420 IMITREX - sumatriptan hemisulphate N02CC Nasal /Spray Within 20 MG/DOSE Guidelines

02212188 IMITREX - sumatriptan succinate N02CC Parenteral Within 12 MG/MILLILITER /Solution Guidelines

02212153 IMITREX DF - sumatriptan succinate N02CC Oral Solid Within 50 MG/TAB /Tablet Guidelines

02212161 IMITREX DF - sumatriptan succinate N02CC Oral Solid Within 100 MG/TAB /Tablet Guidelines

02423596 INCRUSE ELLIPTA - umeclidinium bromide R03BB Pulmonary Within 62.5 MCG/DOSE /Powder Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 61

PMPRB Annual Report 2016

02253852 INFANRIX HEXA combined diphtheria and J07CA Parenteral Subj. tetanus toxoids, acellular /Suspensions Investigation pertussis, hepatitis b or Emulsions (recombinant),

02257122 INFANRIX IPV/HIB combined diphtheria, J07CA Parenteral Within tetanus, acellular pertussis, /Suspensions Guidelines inactivated poliomyelitis, or Emulsions haemophilus

02241284 INFANRIX-IPV diphtheria, tetanus, acellular J07CA Parenteral VCU pertussis and inactivated /Suspensions poliomyelitis vaccine or Emulsions

02366924 LUXIQ - betamethasone valerate D07AC Topical Does Not 1.2 MG/GRAM /Aerosol Trigger

02440709 MENJUGATE LIQUID Meningococcal Group C J07AH Parenteral Introduced Under Review Conjugate Vaccine /Suspensions or Emulsions

02347393 MENVEO - diphteria J07AH Parenteral Within 72 MCG/DOSE toxoid/meningococcal /Powder for Guidelines oligosach. conj. vaccine solution

00587826 NERISONE CREAM - diflucortolone valerate D07AC Topical VCU 1 MG/GRAM /Cream

00587818 NERISONE OILY diflucortolone valerate D07AC Topical VCU CREAM - /Cream 1 MG/GRAM

00587834 NERISONE diflucortolone valerate D07AC Topical VCU OINTMENT - /Ointment 1 MG/GRAM

02344408 OLUX-E - clobetasol propionate D07AD Topical Within 0.5 MG/GRAM /Aerosol Guidelines

00527661 PANOXYL 10 BAR - benzoyl peroxide D10AE Topical VCU 100 MG/GRAM /Other

Patented Drug Products for Human Use Reported to the PMPRB in 2016 62

PMPRB Annual Report 2016

00263699 PANOXYL 10 GEL - benzoyl peroxide D10AE Topical /Gel VCU 100 MG/GRAM

00373036 PANOXYL 20 GEL - benzoyl peroxide D10AE Topical /Gel VCU 200 MG/GRAM

02027887 PAXIL - 10 MG/TAB paroxetine hydrochloride N06AB Oral Solid Expired Within /Tablet Guidelines

01940481 PAXIL - 20 MG/TAB paroxetine hydrochloride N06AB Oral Solid Expired Within /Tablet Guidelines

01940473 PAXIL - 30 MG/TAB paroxetine hydrochloride N06AB Oral Solid Expired Within /Tablet Guidelines

02248503 PAXIL CR - paroxetine hydrochloride N06AB Oral Solid Expired Within 12.5 MG/TAB /Modified Guidelines release tablets

02248504 PAXIL CR - paroxetine hydrochloride N06AB Oral Solid Expired Does Not 25 MG/TAB /Modified Trigger release tablets

00804541 PREVEX B - betamethasone valerate D07AC Topical VCU 1 MG/GRAM /Cream

00804533 PREVEX HC - hydrocortisone D07AC Topical VCU 10 MG/GRAM /Cream

02239208 PRIORIX combined measles, mumps J07BD Parenteral Within and rubella vaccine, live, /Powder for Guidelines attenuated solution

02297884 PRIORIX - TETRA combined measles, mumps, J07BD Parenteral Within rubella and varicella vaccine, /Powder for Guidelines live, attenuated solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 63

PMPRB Annual Report 2016

02232565 REQUIP - ropinirole hydrochloride N04BC Oral Solid VCU 0.25 MG/TAB /Tablet

02232567 REQUIP - ropinirole hydrochloride N04BC Oral Solid VCU 1 MG/TAB /Tablet

02232568 REQUIP - ropinirole hydrochloride N04BC Oral Solid VCU 2 MG/TAB /Tablet

02232569 REQUIP - ropinirole hydrochloride N04BC Oral Solid VCU 5 MG/TAB /Tablet

02008688 RETISOL-A - tretinoin, octinoxate D10AD Topical VCU 0.1 MG/GRAM /avobenzone /Cream

02008718 RETISOL-A - tretinoin, octinoxate D10AD Topical VCU 0.5 MG/GRAM /avobenzone /Cream

02008726 RETISOL-A FORTE - tretinoin, octinoxate D10AD Topical VCU 1 MG/GRAM /avobenzone /Cream

02300591 ROTARIX human rotavirus, live, J07BH Oral Liquid Subj. attenuated, oral vaccine /Powder for Investigation suspension

02214261 SEREVENT DISKHALER salmeterol xinafoate R03AC Pulmonary Does Not - 0.05 MG/DOSE /Powder Trigger

02231129 SEREVENT DISKUS - salmeterol xinafoate R03AC Pulmonary Within 0.05 MG/DOSE /Powder Guidelines

02019825 SOLUGEL - benzoyl peroxide D10AE Topical /Gel VCU 80 MG/GRAM

02247228 STIEPROX SHAMPOO ciclopirox olamine D01AE Topical VCU - 0.015 MG/ /Shampoo MILLILITER

Patented Drug Products for Human Use Reported to the PMPRB in 2016 64

PMPRB Annual Report 2016

00657204 STIEVA-A CREAM - tretinoin D10AD Topical VCU 0.1 MG/GRAM /Cream

00578576 STIEVA-A CREAM - tretinoin D10AD Topical VCU 0.25 MG/GRAM /Cream

00518182 STIEVA-A CREAM - tretinoin D10AD Topical VCU 0.5 MG/GRAM /Cream

00662348 STIEVA-A CREAM - tretinoin D10AD Topical VCU 1 MG/GRAM /Cream

01905112 STIEVAMYCIN tretinoin/erythromycin D10AD Topical /Gel VCU REGULAR - 0.25 MG/GRAM

02230578 TWINRIX 720/20 combined hepatitis a and J07BC Parenteral Subj. hepatitis b vaccine /Suspensions Investigation or Emulsions

02237548 TWINRIX JUNIOR combined hepatitis a & b J07BC Parenteral Within 360/10 vaccine /Suspensions Guidelines or Emulsions

02242727 TYPHERIX salmonella typhi vi capsular J07AP Parenteral VCU polysaccharide vaccine /Solution

02241047 VARILRIX varicella virus vaccine, live, J07BK Parenteral VCU attenuated (oka-strain) /Powder for solution

02243115 VENTOLIN DISKUS - salbutamol sulfate R03AC Pulmonary Expired Subj. 0.2 MG/DOSE /Powder Investigation

02241497 VENTOLIN HFA - salbutamol sulfate R03AC Pulmonary Expired Subj. 0.1 MG/DOSE /Metered Investigation dose preparations

Patented Drug Products for Human Use Reported to the PMPRB in 2016 65

PMPRB Annual Report 2016

02213451 VENTOLIN IV salbutamol sulfate R03AC Parenteral VCU INFUSION - /Solution 1 MG/MILLILITER

02213419 VENTOLIN NEBULES - salbutamol sulfate R03AC Pulmonary VCU 2.5 MG/DOSE /Solution

02213427 VENTOLIN NEBULES - salbutamol sulphate R03AC Pulmonary VCU 5 MG/DOSE /Solution

02213486 VENTOLIN salbutamol sulfate R03AC Pulmonary VCU RESPIRATOR /Solution SOLUTION - 5 MG/MILLILITER

02348489 VERDESO - desonide D07AB Topical Does Not 0.5 MG/GRAM /Aerosol Trigger

02307065 VOLIBRIS - ambrisentan C02KX Oral Solid Within 5 MG/TAB /Tablet Guidelines

02307073 VOLIBRIS - ambrisentan C02KX Oral Solid Within 10 MG/TAB /Tablet Guidelines

00886157 ZOVIRAX - acyclovir J05AB Oral Liquid VCU 40 MG/MILLILITER /Suspension

Grifols Canada Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02247724 GAMUNEX - immune globulin intravenous J06BA Parenteral Within 100 MG/MILLILITER (human) /Solution Guidelines

02189119 PLASBUMIN - albumin (human) B05AA Parenteral Subj. 25 - 250 MG/ /Solution Investigation MILLILITER

Patented Drug Products for Human Use Reported to the PMPRB in 2016 66

PMPRB Annual Report 2016

02189100 PLASBUMIN - albumin (human) B05AA Parenteral Subj. 5 - 50 MG/ /Solution Investigation MILLILITER

02204606 PROLASTIN - alpha1-proteinase inhibitor B02AB Parenteral Does Not 25 MG/MILLILITER (human) /Powder Trigger for solution

Hoffmann-La Roche Limited

DIN Brand Name Chemical Name ATC Dosage Comment Status s

02350092 ACTEMRA - tocilizumab L04AC Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02350106 ACTEMRA - tocilizumab L04AC Parenteral Does Not 20 MG/MILLILITER /Solution Trigger

02350114 ACTEMRA - tocilizumab L04AC Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02424770 ACTEMRA - tocilizumab L04AC Parenteral Subj. 162 MG/SYRINGE /Solution Investigation

02225689 ACTIVASE - alteplase B01AD Parenteral Within 50 MG/VIAL /Solution Guidelines

02147440 ACTIVASE - alteplase B01AD Parenteral Within 100 MG/VIAL /Solution Guidelines

02270994 AVASTIN - bevacizumab L01XC Parenteral Within 25 MG/MILLILITER /Solution Guidelines

02245859 CATHFLO - alteplase B01AD Parenteral Within 2 MG/VIAL /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 67

PMPRB Annual Report 2016

02452340 COTELLIC - cobimetinib fumarate L01XE Oral Solid Introduced Subj. 20 MG/TAB /Tablet Investigation

02409267 ERIVEDGE - vismodegib L01XX Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

02393751 ESBRIET - pirfenidone L04AX Oral Solid Within 267 MG/CAPSULE /Capsule Guidelines

02247725 FUZEON - enfuvirtide J05AX Parenteral Within 108 MG/VIAL /Powder for Guidelines solution

02434806 GAZYVA - obinutuzumab L01XC Parenteral Does Not 25 MG/MILLILITER /Solution Trigger

02240692 HERCEPTIN - trastuzumab L01XC Parenteral Within 440 MG/VIAL /Solution Guidelines

02216965 INVIRASE - saquinavir mesylate J05AE Oral Solid Within 200 MG/CAPSULE /Capsule Guidelines

02279320 INVIRASE - saquinavir mesylate J05AE Oral Solid Within 500 MG/TAB /Tablet Guidelines

02412365 KADCYLA - trastuzumab emtansine L01XC Parenteral Does Not 20 MG/MILLILITER /Powder for Trigger solution

02376393 NUTROPIN AQ somatropin H01AC Parenteral Within NUSPIN 10 - 5 MG/ /Solution Guidelines MILLILITER

02399083 NUTROPIN AQ somatropin H01AC Parenteral Does Not NUSPIN 20 - 10 MG/ /Solution Trigger MILLILITER

02399091 NUTROPIN AQ somatropin H01AC Parenteral Does Not NUSPIN 5 - 2.5 MG/ /Solution Trigger MILLILITER

Patented Drug Products for Human Use Reported to the PMPRB in 2016 68

PMPRB Annual Report 2016

02249002 NUTROPIN AQ PEN - somatropin H01AC Parenteral Subj. 5 MG/MILLILITER /Solution Investigation

02248077 PEGASYS - peginterferon alfa-2a L03AB Parenteral Does Not 180 MCG/SYRINGE /Solution Trigger

02253429 PEGASYS RBV peginterferon alfa-2a + J05AB Other/Other Within ribavirin Guidelines

02405016 PERJETA - pertuzumab L01XC Parenteral Within 420 MG/VIAL /Solution Guidelines

02405024 PERJETA-HERCEPTIN pertuzumab/ trastuzumab L01XC Parenteral Within COMBO PACK /Other Guidelines 420/440

02046733 PULMOZYME - dornase alfa R05CB Pulmonary Within 2.5 MG/AMPULE /Solution Guidelines

02241927 RITUXAN - rituximab L01XC Parenteral Within 10 MG/MILLILITER /Solution Guidelines

02457350 RITUXAN SC - rituximab L01XC Parenteral Introduced Within 120 MG/MILLILITER /Solution Guidelines

02381842 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Liquid Does Not - 6 MG/MILLILITER /Powder for Trigger suspension

02304848 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Solid Within - 30 MG/CAPSULE /Capsule Guidelines

02304856 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Solid Does Not - 45 MG/CAPSULE /Capsule Trigger

02241472 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Solid Within - 75 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 69

PMPRB Annual Report 2016

02269007 TARCEVA - erlotinib hydrochloride L01XX Oral Solid Within 25 MG/TAB /Tablet Guidelines

02269015 TARCEVA - erlotinib hydrochloride L01XX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02269023 TARCEVA - erlotinib hydrocloride L01XX Oral Solid Within 150 MG/TAB /Tablet Guidelines

02244826 TNKASE - tenecteplase B01AD Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02162660 TORADOL - ketorolac tromethamine M01AB Oral Solid Expired Within 10 MG/TAB /Tablet Guidelines

02162644 TORADOL IM - ketorolac tromethamine M01AB Parenteral Expired Within 10 MG/MILLILITER /Solution Guidelines

02306085 VALCYTE - valganciclovir hydrochloride J05AB Oral Liquid Within 50 MG/MILLILITER /Powder for Guidelines solution

02245777 VALCYTE - valganciclovir hydrochloride J05AB Oral Solid Within 450 MG/TAB /Tablet Guidelines

02238453 XELODA - capecitabine L01BC Oral Solid Subj. 150 MG/TAB /Tablet Investigation

02238454 XELODA - capecitabine L01BC Oral Solid Within 500 MG/TAB /Tablet Guidelines

02240325 XENICAL - orlistat A08AB Oral Solid Within 120 MG/CAPSULE /Capsule Guidelines

02380242 ZELBORAF - vemurafenib L01XE Oral Solid Within 240 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 70

PMPRB Annual Report 2016

Horizon Pharma PLC

DIN Brand Name Chemical Name ATC Dosage Comments Status

ACTIMMUNE - interferon gamma 1b L03AB Parenteral/ Within 100 MCG/VIAL Solution Guidelines

Hospira Healthcare Corporation (Canada)

DIN Brand Name Chemical Name ATC Dosage Comments Status

02437147 PRECEDEX - dexmedetomidine N05CM Parenteral Introduced Within 4 MCG/MILLILITER hydrochloride /Solution Guidelines

02339366 PRECEDEX - dexmedetomidine N05CM Parenteral Does Not 100 MCG/MILLILITER hydrochloride /Solution Trigger

Ipsen Biopharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02387735 DYSPORT AESTHETIC abobotulinumtoxina M03AX Parenteral Under - 300 UNIT/VIAL /Powder for Review solution

02283395 SOMATULINE lanreotide H01CB Parenteral Does Not AUTOGEL - /Solution Trigger 60 MG/SYRINGE

02283409 SOMATULINE lanreotide H01CB Parenteral Does Not AUTOGEL - /Solution Trigger 90 MG/SYRINGE

Patented Drug Products for Human Use Reported to the PMPRB in 2016 71

PMPRB Annual Report 2016

02283417 SOMATULINE lanreotide H01CB Parenteral Does Not AUTOGEL - /Solution Trigger 120 MG/SYRINGE

Janssen Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02238389 CAELYX - doxorubicin hydrochloride L01DB Parenteral Within 2 MG/MILLILITER /Solution Guidelines

02247732 CONCERTA - methylphenidate N06BA Oral Solid Within 18 MG/TAB hydrochloride /Modified Guidelines release tablets

02250241 CONCERTA - methylphenidate N06BA Oral Solid Within 27 MG/TAB hydrochloride /Modified Guidelines release tablets

02247733 CONCERTA - methylphenidate N06BA Oral Solid Within 36 MG/TAB hydrochloride /Modified Guidelines release tablets

02247734 CONCERTA - methylphenidate N06BA Oral Solid Within 54 MG/TAB hydrochloride /Modified Guidelines release tablets

02243960 DITROPAN XL - oxybutynin chloride G04BD Oral Solid Expired Does Not 5 MG/TAB /Modified Trigger release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 72

PMPRB Annual Report 2016

02243961 DITROPAN XL - oxybutynin chloride G04BD Oral Solid Expired Within 10 MG/TAB /Modified Guidelines release tablets

02370603 EDURANT - rilpivirine hydrochloride J05AG Oral Solid Does Not 25 MG/TAB /Tablet Trigger

02231583 EPREX - epoetin alfa B03XA Parenteral Within 1000 UNIT/SYRINGE /Solution Guidelines

02231584 EPREX - epoetin alfa B03XA Parenteral Within 2000 UNIT/SYRINGE /Solution Guidelines

02231585 EPREX - epoetin alfa B03XA Parenteral Within 3000 UNIT/SYRINGE /Solution Guidelines

02231586 EPREX - epoetin alfa B03XA Parenteral Within 4000 UNIT/SYRINGE /Solution Guidelines

02243400 EPREX - epoetin alfa B03XA Parenteral Within 5000 UNIT/SYRINGE /Solution Guidelines

02243401 EPREX - epoetin alfa B03XA Parenteral Within 6000 UNIT/SYRINGE /Solution Guidelines

02243403 EPREX - epoetin alfa B03XA Parenteral Within 8000 UNIT/SYRINGE /Solution Guidelines

02231587 EPREX - epoetin alfa B03XA Parenteral Within 10000 UNIT/ /Solution Guidelines MILLILITER

02243239 EPREX - epoetin alfa B03XA Parenteral Within 20000 UNIT/SYRINGE /Solution Guidelines

02288680 EPREX - epoetin alfa B03XA Parenteral Within 30000 UNIT/SYRINGE /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 73

PMPRB Annual Report 2016

02240722 EPREX - epoetin alfa B03XA Parenteral Within 40000 UNIT/ /Solution Guidelines MILLILITER

02248297 EVRA 150/20 norelgestromin/ethinyl G03AA Topical Expired Within estradiol /Patches Guidelines

02416441 GALEXOS - simeprevir J05AE Oral Solid Does Not 150 MG/CAPSULE /Capsule Trigger

02434407 IMBRUVICA - ibrutinib L01XE Oral Solid Within 140 MG/CAPSULE /Capsule Guidelines

02306778 INTELENCE - etravirine J05AG Oral Solid Within 100 MG/TAB /Tablet Guidelines

02375931 INTELENCE - etravirine J05AG Oral Solid Does Not 200 MG/TAB /Tablet Trigger

02300273 INVEGA - paliperidone N05AX Oral Solid Does Not 3 MG/TAB /Modified Trigger release tablets

02300281 INVEGA - paliperidone N05AX Oral Solid Does Not 6 MG/TAB /Modified Trigger release tablets

02300303 INVEGA - paliperidone N05AX Oral Solid Does Not 9 MG/TAB /Modified Trigger release tablets

02354217 INVEGA SUSTENNA - paliperidone palmitate N05AX Parenteral Within 50 MG/SYRINGE /Modified Guidelines release injections

Patented Drug Products for Human Use Reported to the PMPRB in 2016 74

PMPRB Annual Report 2016

02354225 INVEGA SUSTENNA - paliperidone palmitate N05AX Parenteral Within 75 MG/SYRINGE /Modified Guidelines release injections

02354233 INVEGA SUSTENNA - paliperidone palmitate N05AX Parenteral Within 100 MG/SYRINGE /Modified Guidelines release injections

02354241 INVEGA SUSTENNA - paliperidone palmitate N05AX Parenteral Within 150 MG/SYRINGE /Modified Guidelines release injections

02455943 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral / Introduced Within 175 MG/SYRINGE Suspension Guidelines (extended release)

02455986 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral / Introduced Within 263 MG/SYRINGE Suspension Guidelines (extended release)

02455994 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral / Introduced Within 350 MG/SYRINGE Suspension Guidelines (extended release)

02456001 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral / Introduced Within 525 MG/SYRINGE Suspension Guidelines (extended release)

02455455 INVOKAMET canagliflozin/metformin A10BD Oral Solid Introduced Under 150/1000 hydrochloride /Tablet Review

02455439 INVOKAMET canagliflozin/metformin A10BD Oral Solid Introduced Under 150/500 hydrochloride /Tablet Review

Patented Drug Products for Human Use Reported to the PMPRB in 2016 75

PMPRB Annual Report 2016

02455447 INVOKAMET 150/850 canagliflozin/metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02455420 INVOKAMET 50/1000 canagliflozin and metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02455404 INVOKAMET 50/500 canagliflozin and metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02455412 INVOKAMET 50/850 canagliflozin and metformin A10BD Oral Solid Introduced Under hydrochloride /Tablet Review

02425483 INVOKANA - canagliflozin A10BX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02425491 INVOKANA - canagliflozin A10BX Oral Solid Within 300 MG/TAB /Tablet Guidelines

02415577 NUCYNTA EXTENDED tapentadol hydrochloride N02AX Oral Solid Does Not RELEASE - /Modified Trigger 50 MG/TAB release tablets

02415585 NUCYNTA EXTENDED tapentadol hydrochloride N02AX Oral Solid Does Not RELEASE - /Modified Trigger 100 MG/TAB release tablets

02415593 NUCYNTA EXTENDED tapentadol hydrochloride N02AX Oral Solid Does Not RELEASE - /Modified Trigger 150 MG/TAB release tablets

02415607 NUCYNTA EXTENDED tapentadol hydrochloride N02AX Oral Solid Does Not RELEASE - /Modified Trigger 200 MG/TAB release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 76

PMPRB Annual Report 2016

02415615 NUCYNTA EXTENDED tapentadol hydrochloride N02AX Oral Solid Does Not RELEASE - /Modified Trigger 250 MG/TAB release tablets

02378272 NUCYNTA IR - tapentadol hydrochloride N02AX Oral Solid Does Not 50 MG/TAB /Tablet Trigger

02378280 NUCYNTA IR - tapentadol hydrochloride N02AX Oral Solid Does Not 75 MG/TAB /Tablet Trigger

02378299 NUCYNTA IR - tapentadol hydrochloride N02AX Oral Solid Does Not 100 MG/TAB /Tablet Trigger

02426501 PREZCOBIX 800/150 darunavir/cobicistat J05AR Oral Solid Subj. /Tablet Investigation

02338432 PREZISTA - darunavir ethanolate J05AE Oral Solid Does Not 75 MG/TAB /Tablet Trigger

02369753 PREZISTA - darunavir ethanolate J05AE Oral Solid Does Not 150 MG/TAB /Tablet Trigger

02324024 PREZISTA - darunavir ethanolate J05AE Oral Solid Does Not 600 MG/TAB /Tablet Trigger

02393050 PREZISTA - darunavir ethanolate J05AE Oral Solid Within 800 MG/TAB /Tablet Guidelines

02244016 REMICADE - infliximab L04AB Parenteral Within 100 MG/VIAL /Powder for Guidelines solution

02266717 REMINYL ER - galantamine hydrobromide N06DA Oral Solid Does Not 8 MG/CAPSULE /Modified Trigger release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 77

PMPRB Annual Report 2016

02266725 REMINYL ER - galantamine hydrobromide N06DA Oral Solid Does Not 16 MG/CAPSULE /Modified Trigger release capsules

02266733 REMINYL ER - galantamine hydrobromide N06DA Oral Solid Does Not 24 MG/CAPSULE /Modified Trigger release capsules

02377012 RESOTRAN - prucalopride succinate A03AE Oral Solid Does Not 1 MG/TAB /Tablet Trigger

02377020 RESOTRAN - prucalopride succinate A03AE Oral Solid Does Not 2 MG/TAB /Tablet Trigger

02236950 RISPERDAL - risperidone N05AX Oral Liquid Within 1 MG/MILLILITER /Solution Guidelines

02240551 RISPERDAL - risperidone N05AX Oral Solid Within 0.25 MG/TAB /Tablet Guidelines

02240552 RISPERDAL - risperidone N05AX Oral Solid Does Not 0.5 MG/TAB /Tablet Trigger

02025280 RISPERDAL - risperidone N05AX Oral Solid Within 1 MG/TAB /Tablet Guidelines

02025299 RISPERDAL - risperidone N05AX Oral Solid Within 2 MG/TAB /Tablet Guidelines

02025302 RISPERDAL - risperidone N05AX Oral Solid Does Not 3 MG/TAB /Tablet Trigger

02025310 RISPERDAL - risperidone N05AX Oral Solid Does Not 4 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 78

PMPRB Annual Report 2016

02298465 RISPERDAL CONSTA - risperidone N05AX Parenteral Within 12.5 MG/VIAL /Modified Guidelines release injections

02255707 RISPERDAL CONSTA - risperidone N05AX Parenteral Does Not 25 MG/VIAL /Modified Trigger release injections

02255723 RISPERDAL CONSTA - risperidone N05AX Parenteral Within 37.5 MG/VIAL /Modified Guidelines release injections

02255758 RISPERDAL CONSTA - risperidone N05AX Parenteral Does Not 50 MG/VIAL /Modified Trigger release injections

02247704 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 0.5 MG/TAB /Tablet Trigger

02247705 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 1 MG/TAB /Tablet Trigger

02247706 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 2 MG/TAB /Tablet Trigger

02268086 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 3 MG/TAB /Tablet Trigger

02268094 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 4 MG/TAB /Tablet Trigger

02324776 SIMPONI - golimumab L04AB Parenteral Within 50 MG/SYRINGE /Solution Guidelines

02324784 SIMPONI - golimumab L04AB Parenteral Within 50 MG/SYRINGE /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 79

PMPRB Annual Report 2016

02417472 SIMPONI - golimumab L04AB Parenteral Within 50 MG/VIAL /Solution Guidelines

02413183 SIMPONI - golimumab L04AB Parenteral Within 100 MG/MILLILITER /Solution Guidelines

02413175 SIMPONI - golimumab L04AB Parenteral Within 100 MG/SYRINGE /Solution Guidelines

02047454 SPORANOX - itraconazole J02AC Oral Solid Does Not 100 MG/CAPSULE /Capsule Trigger

02231347 SPORANOX ORAL itraconazole J02AC Oral Liquid Does Not SOLUTION - /Solution Trigger 10 MG/MILLILITER

02320673 STELARA - ustekinumab L04AC Parenteral Within 45 MG/VIAL /Solution Guidelines

02320681 STELARA - ustekinumab L04AC Parenteral Within 90 MG/VIAL /Solution Guidelines

02435128 SYLVANT - siltuximab L04AC Parenteral Within 100 MG/VIAL /Powder for Guidelines solution

02435136 SYLVANT - siltuximab L04AC Parenteral Does Not 400 MG/VIAL /Powder for Trigger solution

02230893 TOPAMAX - topiramate N03AX Oral Solid Does Not 25 MG/TAB /Tablet Trigger

02230894 TOPAMAX - topiramate N03AX Oral Solid Does Not 100 MG/TAB /Tablet Trigger

02230896 TOPAMAX - topiramate N03AX Oral Solid Does Not 200 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 80

PMPRB Annual Report 2016

02239907 TOPAMAX SPRINKLE - topiramate N03AX Oral Solid Within 15 MG/CAPSULE /Capsule Guidelines

02239908 TOPAMAX SPRINKLE - topiramate N03AX Oral Solid Within 25 MG/CAPSULE /Capsule Guidelines

02349469 ULTRAM - tramadol hydrochloride N02AX Oral Solid Within 50 MG/TAB /Tablet Guidelines

02262452 VELCADE - bortezomib L01XX Parenteral Within 3.5 MG/VIAL /Powder for Guidelines solution

02351528 YONDELIS - trabectedin for injection L01CX Parenteral Does Not 1 MG/VIAL /Powder for Trigger solution

02371065 ZYTIGA - abiraterone acetate L02BX Oral Solid Within 250 MG/TAB /Tablet Guidelines

02457113 ZYTIGA - abiraterone acetate L02BX Oral Solid Introduced Does Not 500 MG/TAB /Tablet Trigger

Jazz Pharmaceuticals, PLC

DIN Brand Name Chemical Name ATC Dosage Comments Status

DEFITELIO - defibrotide B01AX Parenteral Under 200 MG/VIAL /Solution Review

Patented Drug Products for Human Use Reported to the PMPRB in 2016 81

PMPRB Annual Report 2016

Johnson & Johnson Medical Products

DIN Brand Name Chemical Name ATC Dosage Comments Status

02348497 EVICEL thrombin (human)/ fibrinogen B02BC Topical / Expired Within (human) Liquid Guidelines

Lantheus MI Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02243173 DEFINITY - perflutren V08DA Parenteral Expired Within 150 MCL/MILLILITER /Suspensions Guidelines or Emulsions

Leo Pharma Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02244126 DOVOBET 0.05/0.5 calcipotriol/betamethasone D05AX Topical Does Not dipropionate /Ointment Trigger

02457393 ENSTILAR - calcipotriol/betamethasone D05AX Topical Introduced Under 0.55 MG/GRAM /Aerosol Review

02400987 PICATO ingenol mebutate D06BX Topical /Gel Within 0,15 - 70 MCG/TUBE Guidelines

02400995 PICATO ingenol mebutate D06BX Topical /Gel Within 0,5 - 235 MCG/TUBE Guidelines

02319012 XAMIOL 0.05/0.5 calcipotriol/betamethasone D05AX Topical /Gel Within dipropionate Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 82

PMPRB Annual Report 2016

Lundbeck Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02239607 CELEXA - citalopram hydrobromide N06AB Oral Solid Within 20 MG/TAB /Tablet Guidelines

02239608 CELEXA - citalopram hydrobromide N06AB Oral Solid Within 40 MG/TAB /Tablet Guidelines

02263238 CIPRALEX - escitalopram oxalate N06AB Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02263254 CIPRALEX - escitalopram oxalate N06AB Oral Solid Does Not 20 MG/TAB /Tablet Trigger

02391449 CIPRALEX MELTZ - escitalopram N06AB Oral Solid Within 10 MG/TAB /Tablet Guidelines

02391457 CIPRALEX MELTZ - escitalopram N06AB Oral Solid Within 20 MG/TAB /Tablet Guidelines

02260638 EBIXA - memantine hydrochloride N06DX Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02374803 SAPHRIS - asenapine N05AH Dental - Within 5 MG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02374811 SAPHRIS - asenapine N05AH Dental - Within 10 MG/TAB Sublingual Guidelines Buccal /Sublingual tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 83

PMPRB Annual Report 2016

02432919 TRINTELLIX - vortioxetine hydrobromide N06AX Oral Solid Within 5 MG/TAB /Tablet Guidelines

02432927 TRINTELLIX - vortioxetine hydrobromide N06AX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02432943 TRINTELLIX - vortioxetine hydrobromide N06AX Oral Solid Within 20 MG/TAB /Tablet Guidelines

Lupin Pharma Canada Limited

DIN Brand Name Chemical Name ATC Dosage Comments Status

02308215 RELISTOR - methylnaltrexone bromide A06AH Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02410702 ZAXINE - rifaximin A07AA Oral Solid Does Not 550 MG/TAB /Tablet Trigger

Meda Pharmaceuticals Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02432889 DYMISTA 137/50 azelastine hydrochloride/ R01AD Nasal Within fluticasone propionate /Solution Guidelines

Medical Futures Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02373017 DURELA - tramadol hydrochloride N02AX Oral Solid Within 100 MG/CAPSULE /Modified Guidelines release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 84

PMPRB Annual Report 2016

02373025 DURELA - tramadol hydrochloride N02AX Oral Solid Within 200 MG/CAPSULE /Modified Guidelines release capsules

02373033 DURELA - tramadol hydrochloride N02AX Oral Solid Does Not 300 MG/CAPSULE /Modified Trigger release capsules

Merck Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

00782327 ANDRIOL - testosterone undecanoate G03BA Oral Solid Within 40 MG/CAPSULE /Capsule Guidelines

02438690 ASMANEX mometasone furoate R03BA Pulmonary Within TWISTHALER - /Powder Guidelines 100 MCG/DOSE

02243595 ASMANEX mometasone furoate R03BA Pulmonary Within TWISTHALER - /Powder Guidelines 200 MCG/DOSE

02243596 ASMANEX mometasone furoate R03BA Pulmonary Within TWISTHALER - /Powder Guidelines 400 MCG/DOSE

02455331 BRENZYS - etanercept L04AB Parenteral Introduced Within 50 MG/MILLILITER /Solution Guidelines

02455323 BRENZYS - etanercept L04AB Parenteral Introduced Within 50 MG/MILLILITER /Solution Guidelines

02451816 BRIDION - sugammadex V03AB Parenteral Introduced Subj. 100 MG/MILLILITER /Solution Investigation

Patented Drug Products for Human Use Reported to the PMPRB in 2016 85

PMPRB Annual Report 2016

02244265 CANCIDAS - caspofungin acetate J02AX Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02244266 CANCIDAS - caspofungin acetate J02AX Parenteral Within 70 MG/VIAL /Powder for Guidelines solution

02387174 DIFICID - fidaxomicin A07AA Oral Solid Within 200 MG/TAB /Tablet Guidelines

02298791 EMEND - aprepitant A04AD Oral Solid Within 80 MG/CAPSULE /Capsule Guidelines

02298805 EMEND - aprepitant A04AD Oral Solid Within 125 MG/CAPSULE /Capsule Guidelines

02298813 EMEND aprepitant A04AD Oral Solid Within 125MG/80MG /Capsule Guidelines TRIPAK

02247521 EZETROL - ezetimibe C10AX Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02283190 GARDASIL papillomavirus J07BM Parenteral Within recombinant vaccine /Suspensions Guidelines or Emulsions

02437058 GARDASIL 9 human papillomavirus 9- J07BM Parenteral Within valent vaccine recombinant /Suspensions Guidelines or Emulsions

02418304 GRASTEK - standardized allergenic V01AA Dental - Within 2800 UNIT/TAB extract, timothy grass Sublingual Guidelines (phleum pratense) Buccal /Sublingual tablets

02240351 INTEGRILIN - eptifibatide B01AC Parenteral Within 0.75 MG/MILLILITER /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 86

PMPRB Annual Report 2016

02240352 INTEGRILIN - eptifibatide B01AC Parenteral Within 2 MG/MILLILITER /Solution Guidelines

02223406 INTRON-A - interferon alfa-2b L03AB Parenteral Within 10000000 UNIT/VIAL /Powder for Guidelines solution

02238674 INTRON-A HSA FREE - interferon alfa-2b L03AB Parenteral Does Not 6000000 UNIT/ /Solution Trigger MILLILITER

02238675 INTRON-A HSA FREE - interferon alfa-2b L03AB Parenteral Within 10000000 UNIT/ /Solution Guidelines MILLILITER

02240693 INTRON-A PEN HSA interferon alfa-2b L03AB Parenteral Does Not FREE - 15000000 /Solution Trigger UNIT/MILLILITER

02240694 INTRON-A PEN HSA interferon alfa-2b L03AB Parenteral Does Not FREE - 25000000 /Solution Trigger UNIT/MILLILITER

02240695 INTRON-A PEN HSA interferon alfa-2b L03AB Parenteral Does Not FREE - 50000000 /Solution Trigger UNIT/MILLILITER

02247437 INVANZ - ertapenem sodium J01DH Parenteral Within 1000 MG/VIAL /Powder for Guidelines solution

02392429 ISENTRESS - raltegravir potassium J05AX Oral Solid Does Not 25 MG/TAB /Tablet Trigger

02392437 ISENTRESS - raltegravir potassium J05AX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02301881 ISENTRESS - 400 raltegravir potassium J05AX Oral Solid Within MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 87

PMPRB Annual Report 2016

02333872 JANUMET 50/1000 sitagliptin A10BD Oral Solid Within phosphate/metformin /Tablet Guidelines hydrochloride

02333856 JANUMET 50/500 sitagliptin A10BD Oral Solid Within phosphate/metformin /Tablet Guidelines hydrochloride

02333864 JANUMET 50/850 sitagliptin A10BD Oral Solid Within phosphate/metformin /Tablet Guidelines hydrochloride

02416794 JANUMET XR sitagliptin phosphate A10BD Oral Solid Within 50/1000 monohydrate/metformin /Modified Guidelines hydrochloride release tablets

02416786 JANUMET XR 50/500 sitagliptin phosphate A10BD Oral Solid Does Not monohydrate/metformin /Modified Trigger hydrochloride release tablets

02416808 JANUMET sitagliptin phosphate A10BD Oral Solid Subj. XR100/1000 monohydrate/metformin /Modified Investigation hydrochloride release tablets

02388839 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 25 MG/TAB /Tablet Guidelines

02388847 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 50 MG/TAB /Tablet Guidelines

02303922 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 100 MG/TAB /Tablet Guidelines

02441152 KEYTRUDA - pembrolizumab L01XC Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 88

PMPRB Annual Report 2016

02253186 NUVARING etonogestrel/ethinyl G02BB Vaginal Does Not 0.12/0.015 estradiol /Insert Trigger

02246030 PEGETRON 150 peginterferon alfa-2b + L03AB Other/Other Does Not ribavirin Trigger

02254603 PEGETRON peginterferon alfa-2b + L03AB Other/Other Does Not REDIPEN 100 ribavirin Trigger

02254638 PEGETRON peginterferon alfa-2b + L03AB Other/Other Does Not REDIPEN 120 ribavirin Trigger

02254646 PEGETRON peginterferon alfa-2b + L03AB Other/Other Does Not REDIPEN 150 ribavirin Trigger

02254581 PEGETRON peginterferon alfa-2b + L03AB Other/Other Does Not REDIPEN 80 ribavirin Trigger

02293404 POSANOL - posaconazole J02AC Oral Liquid Within 40 MG/MILLILITER /Suspension Guidelines

02424622 POSANOL - posaconazole J02AC Oral Solid Within 100 MG/TAB /Tablet Guidelines

02432676 POSANOL - posaconazole J02AC Parenteral Within 300 MG/VIAL /Solution Guidelines

02243948 PUREGON follitropin beta D1044 G03GA Parenteral Subj. /Solution Investigation

02423723 RAGWITEK - standardized allergen V01AA Dental - Within 12 UNIT/TAB extract, short ragweed Sublingual Guidelines (ambrosia artemisifolia) Buccal /Sublingual tablets

02243676 RECOMBIVAX HB hepatitis b vaccine (rdna) J07BC Parenteral Within THIMEROSAL FREE - /Suspensions Guidelines 10 MCG/MILLILITER or Emulsions

Patented Drug Products for Human Use Reported to the PMPRB in 2016 89

PMPRB Annual Report 2016

02245977 RECOMBIVAX HB hepatitis b vaccine (rdna) J07BC Parenteral Subj. THIMEROSAL FREE - /Suspensions Investigation 40 MCG/MILLILITER or Emulsions

02284413 ROTATEQ oral live rotavirus vaccine, J07BH Oral Liquid Does Not pentavalent /Suspension Trigger

02247997 SINGULAIR - montelukast sodium R03DC Oral Solid Does Not 4 MG/POUCH /Effervescent Trigger granules

02243602 SINGULAIR - montelukast sodium R03DC Oral Solid Does Not 4 MG/TAB /Tablet Trigger

02238216 SINGULAIR - montelukast sodium R03DC Oral Solid Does Not 5 MG/TAB /Tablet Trigger

02238217 SINGULAIR - montelukast sodium R03DC Oral Solid Within 10 MG/TAB /Tablet Guidelines

02370816 VICTRELIS - boceprevir J05AE Oral Solid Within 200 MG/CAPSULE /Capsule Guidelines

02371456 VICTRELIS TRIPLE boceprevir/ribavirin plus/ L03AB Other/Other Within 200/200/100 peginterferon alpha-2b Guidelines

02371464 VICTRELIS TRIPLE boceprevir/ribavirin plus/ L03AB Other/Other Within 200/200/120 peginterferon alpha-2b Guidelines

02371472 VICTRELIS TRIPLE boceprevir/ribavirin plus/ L03AB Other/Other Within 200/200/150 peginterferon alpha-2b Guidelines

02371448 VICTRELIS TRIPLE boceprevir/ribavirin plus/ L03AB Other/Other Within 200/200/80 peginterferon alpha-2b Guidelines

02361752 ZENHALE 100/5 mometasone furoate/ R03AK Pulmonary Within formoterol fumarate /Metered Guidelines dose preparations

Patented Drug Products for Human Use Reported to the PMPRB in 2016 90

PMPRB Annual Report 2016

02361760 ZENHALE 200/5 mometasone furoate/ R03AK Pulmonary Within formoterol fumarate /Metered Guidelines dose preparations

02361744 ZENHALE 50/5 mometasone furoate/ R03AK Pulmonary Does Not formoterol fumarate /Metered Trigger dose preparations

02451131 ZEPATIER 50/100 elbasvir/grazoprevir J05AX Oral Solid Introduced Subj. /Tablet Investigation

02446901 ZERBAXA 1000/500 ceftolozane/tazobactam J01DI Parenteral Introduced Under Review /Powder for solution

02327619 ZOLINZA - vorinostat L01XX Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

Merus Labs Luxco S.À.R.L.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02273217 ENABLEX - darifenacin hydrobromide G04BD Oral Solid Does Not 7.5 MG/TAB /Tablet Trigger

02273225 ENABLEX - darifenacin hydrobromide G04BD Oral Solid Does Not 15 MG/TAB /Tablet Trigger

Merz Pharma Canada Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02371081 XEOMIN - incobotulinumtoxin a M03AX Parenteral Within 50 UNIT/VIAL /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 91

PMPRB Annual Report 2016

02324032 XEOMIN - botulinum toxin type a M03AX Parenteral Within 100 UNIT/VIAL (150kd) /Powder for Guidelines solution

02383489 XEOMIN COSMETIC - botulinum toxin type a M03AX Parenteral Within 100 UNIT/VIAL (150kd) /Powder for Guidelines solution

Novartis Pharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02269198 ACLASTA - 5 MG/VIAL zoledronic acid M05BA Parenteral Within /Solution Guidelines

02369257 AFINITOR - everolimus L04AA Oral Solid Within 2.5 MG/TAB /Tablet Guidelines

02339501 AFINITOR - everolimus L04AA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02450267 AFINITOR - everolimus L04AA Oral Solid Introduced Does Not 7.5 MG/TAB /Tablet Trigger

02339528 AFINITOR - everolimus L04AA Oral Solid Within 10 MG/TAB /Tablet Guidelines

02425645 AFINITOR DISPERZ - everolimus L04AA Oral Solid Within 2 MG/TAB /Tablet Guidelines

02425653 AFINITOR DISPERZ - everolimus L04AA Oral Solid Within 3 MG/TAB /Tablet Guidelines

02425661 AFINITOR DISPERZ - everolimus L04AA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02243763 COMTAN - entacapone N04BX Oral Solid Does Not 200 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 92

PMPRB Annual Report 2016

02438070 COSENTYX - secukinumab L04AC Parenteral Within 150 MG/MILLILITER /Solution Guidelines

02270528 DIOVAN - valsartan C09CA Oral Solid Expired Within 40 MG/TAB /Tablet Guidelines

02244781 DIOVAN - valsartan C09CA Oral Solid Expired Within 80 MG/TAB /Tablet Guidelines

02244782 DIOVAN - valsartan C09CA Oral Solid Expired Within 160 MG/TAB /Tablet Guidelines

02289504 DIOVAN - valsartan C09CA Oral Solid Expired Within 320 MG/TAB /Tablet Guidelines

02446928 ENTRESTO 24.3/25.7 sacubitril/valsartan C09DX Oral Solid Within /Tablet Guidelines

02446936 ENTRESTO 48.6/51.4 sacubitril/valsartan C09DX Oral Solid Within /Tablet Guidelines

02446944 ENTRESTO sacubitril/valsartan C09DX Oral Solid Within 97.2/102.8 /Tablet Guidelines

02241835 ESTALIS 140/50 norethindrone G03FA Topical Expired Within acetate/estradiol 17ß /Patches Guidelines

02241837 ESTALIS 250/50 norethindrone G03FA Topical Expired Within acetate/estradiol 17ß /Patches Guidelines

02302853 EXELON PATCH rivastigmine N06DA Topical Within 10 - 18 MG/PATCH /Patches Guidelines

02302845 EXELON PATCH rivastigmine N06DA Topical Within 5 - 9 MG/PATCH /Patches Guidelines

02432803 EXELON PATCH rivastigmine N06DA Topical Does Not 15 - 27 MG/PATCH /Patches Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 93

PMPRB Annual Report 2016

02287420 EXJADE - deferasirox V03AC Oral Solid Within 125 MG/TAB /Tablet Guidelines

02287439 EXJADE - deferasirox V03AC Oral Solid Within 250 MG/TAB /Tablet Guidelines

02287447 EXJADE - deferasirox V03AC Oral Solid Within 500 MG/TAB /Tablet Guidelines

02337819 EXTAVIA - interferon beta-1b L03AB Parenteral Within 0.3 MG/VIAL /Powder for Guidelines solution

02229110 FAMVIR - famciclovir J05AB Oral Solid Within 125 MG/TAB /Tablet Guidelines

02229129 FAMVIR - famciclovir J05AB Oral Solid Within 250 MG/TAB /Tablet Guidelines

02177102 FAMVIR - famciclovir J05AB Oral Solid Within 500 MG/TAB /Tablet Guidelines

02362384 FLUAD - haemagglutinin-strain: J07BB Parenteral Subj. 45 MCG/DOSE a(h1n1), a(h3n2) & b /Suspensions Investigation or Emulsions

02434881 FLUAD PEDIATRIC - haemagglutinin-strain: J07BB Parenteral Subj. 22.5 MCG/DOSE a(h1n1), a(h3n2) & b /Suspensions Investigation or Emulsions

02365480 GILENYA - fingolimod hydrochloride L04AA Oral Solid Within 0.5 MG/CAPSULE /Capsule Guidelines

02253275 GLEEVEC - imatinib mesylate L01XX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02253283 GLEEVEC - imatinib mesylate L01XX Oral Solid Within 400 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 94

PMPRB Annual Report 2016

02344939 ILARIS - canakinumab L04AC Parenteral Within 150 MG/VIAL /Powder for Guidelines solution

02452219 JADENU - deferasirox V03AC Oral Solid Introduced Does Not 90 MG/TAB /Tablet Trigger

02452227 JADENU - deferasirox V03AC Oral Solid Introduced Does Not 180 MG/TAB /Tablet Trigger

02452235 JADENU - deferasirox V03AC Oral Solid Introduced Does Not 360 MG/TAB /Tablet Trigger

02388006 JAKAVI - ruxolitinib L01XE Oral Solid Within 5 MG/TAB /Tablet Guidelines

02434814 JAKAVI - ruxolitinib L01XE Oral Solid Within 10 MG/TAB /Tablet Guidelines

02388014 JAKAVI - ruxolitinib L01XE Oral Solid Within 15 MG/TAB /Tablet Guidelines

02388022 JAKAVI - ruxolitinib L01XE Oral Solid Within 20 MG/TAB /Tablet Guidelines

02250527 LESCOL XL - fluvastatin sodium C10AA Oral Solid Within 80 MG/TAB /Modified Guidelines release tablets

02296810 LUCENTIS - ranibizumab S01LA Parenteral Within 0.5 MG/DOSE /Solution Guidelines

02425629 LUCENTIS - ranibizumab S01LA Parenteral Within 0.5 MG/DOSE /Solution Guidelines

02409623 MEKINIST - trametinib L01XE Oral Solid Within 0.5 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 95

PMPRB Annual Report 2016

02409658 MEKINIST - trametinib L01XE Oral Solid Within 2 MG/TAB /Tablet Guidelines

02264560 MYFORTIC - mycophenolate sodium L04AA Oral Solid Subj. 180 MG/TAB /Tablet Investigation

02264579 MYFORTIC - mycophenolate sodium L04AA Oral Solid Subj. 360 MG/TAB /Tablet Investigation

02376938 ONBREZ BREEZHALER indacaterol maleate R03AC Pulmonary Within - 75 MCG/CAPSULE /Powder Guidelines

02130181 PROLEUKIN - aldesleukin L03AC Parenteral Within 22000000 UNIT/VIAL /Powder for Guidelines solution

02302063 RASILEZ - aliskiren C09XA Oral Solid Within 150 MG/TAB /Tablet Guidelines

02302071 RASILEZ - aliskiren C09XA Oral Solid Within 300 MG/TAB /Tablet Guidelines

02332728 RASILEZ aliskiren/ C09XA Oral Solid Within HCT 150/12.5 hydrochlorothiazide /Tablet Guidelines

02332736 RASILEZ aliskiren/ C09XA Oral Solid Within HCT 150/25 hydrochlorothiazide /Tablet Guidelines

02332744 RASILEZ HCT aliskiren/ C09XA Oral Solid Within 300/12.5 hydrochlorothiazide /Tablet Guidelines

02332752 RASILEZ HCT 300/25 aliskiren/ C09XA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02361825 REVOLADE - eltrombopag olamine B02BX Oral Solid Within 25 MG/TAB /Tablet Guidelines

02361833 REVOLADE - eltrombopag olamine B02BX Oral Solid Within 50 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 96

PMPRB Annual Report 2016

02288389 SEBIVO - telbivudine J05AF Oral Solid Within 600 MG/TAB /Tablet Guidelines

02394936 SEEBRI BREEZHALER - glycopyrronium bromide R03BB Pulmonary Within 50 MCG/CAPSULE /Powder Guidelines

02413299 SIGNIFOR - pasireotide H01CB Parenteral Within 0.3 MG/MILLILITER /Solution Guidelines

02413302 SIGNIFOR - pasireotide H01CB Parenteral Within 0.6 MG/MILLILITER /Solution Guidelines

02413310 SIGNIFOR - pasireotide H01CB Parenteral Within 0.9 MG/MILLILITER /Solution Guidelines

02437252 SIGNIFOR LAR - pasireotide H01CB Parenteral Introduced Within 20 MG/VIAL /Powder for Guidelines solution

02437260 SIGNIFOR LAR - pasireotide H01CB Parenteral Does Not 40 MG/VIAL /Powder for Trigger solution

02437279 SIGNIFOR LAR - pasireotide H01CB Parenteral Does Not 60 MG/VIAL /Powder for Trigger solution

02305941 STALEVO levodopa/carbidopa/ N04BA Oral Solid Within 100/25/200 entacapone /Tablet Guidelines

02337835 STALEVO levodopa/carbidopa/ N04BA Oral Solid Within 125/31.25/200 entacapone /Tablet Guidelines

02305968 STALEVO levodopa/carbidopa/ N04BA Oral Solid Within 150/37.5/200 entacapone /Tablet Guidelines

02305933 STALEVO levodopa/carbidopa/ N04BA Oral Solid Within 50/12.5/200 entacapone /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 97

PMPRB Annual Report 2016

02337827 STALEVO levodopa/carbidopa/entac N04BA Oral Solid Within 75/18.75/200 apone /Tablet Guidelines

02409607 TAFINLAR - dabrafenib L01XE Oral Solid Within 50 MG/CAPSULE /Capsule Guidelines

02409615 TAFINLAR - dabrafenib L01XE Oral Solid Within 75 MG/CAPSULE /Capsule Guidelines

02368250 TASIGNA - nilotinib hydrochloride L01XE Oral Solid Within 150 MG/CAPSULE monohydrate /Capsule Guidelines

02315874 TASIGNA - nilotinib hydrochloride L01XE Oral Solid Within 200 MG/CAPSULE monohydrate /Capsule Guidelines

02365154 TOBI PODHALER - tobramycin J01GB Pulmonary Within 28 MG/CAPSULE /Powder Guidelines

02244673 TRILEPTAL - oxcarbazepine N03AF Oral Liquid Within 60 MG/MILLILITER /Suspension Guidelines

02242067 TRILEPTAL - oxcarbazepine N03AF Oral Solid Within 150 MG/TAB /Tablet Guidelines

02242068 TRILEPTAL - oxcarbazepine N03AF Oral Solid Within 300 MG/TAB /Tablet Guidelines

02242069 TRILEPTAL - oxcarbazepine N03AF Oral Solid Within 600 MG/TAB /Tablet Guidelines

02326442 TYKERB - lapatinib ditosylate L01XE Oral Solid Within 250 MG/TAB monohydrate /Tablet Guidelines

02418282 ULTIBRO indacaterol maleate/ R03AL Pulmonary Within BREEZHALER 110/50 glycopyrronium bromide /Powder Guidelines

02242367 VISUDYNE - verteporfin L01XX Parenteral Within 15 MG/VIAL /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 98

PMPRB Annual Report 2016

02352303 VOTRIENT - pazopanib hydrochloride L01XE Oral Solid Within 200 MG/TAB /Tablet Guidelines

02260565 XOLAIR - omalizumab R03DX Parenteral Within 150 MG/VIAL /Powder for Guidelines solution

02248296 ZOMETA - zoledronic acid M05BA Parenteral Expired Within 4 MG/VIAL /Solution Guidelines

02436779 ZYKADIA - ceritinib L01XE Oral Solid Subj. 150 MG/CAPSULE /Capsule Investigation

Novo Nordisk Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02417103 NIASTASE RT - eptacog alfa (activated) B02BD Parenteral Within 1 MG/VIAL /Powder for Guidelines solution

02417111 NIASTASE RT - eptacog alfa (activated) B02BD Parenteral Within 2 MG/VIAL /Powder for Guidelines solution

02417138 NIASTASE RT - eptacog alfa (activated) B02BD Parenteral Within 5 MG/VIAL /Powder for Guidelines solution

02334852 NORDITROPIN somatropin H01AC Parenteral Does Not NORDIFLEX - /Solution Trigger 5 MG/PEN

02334860 NORDITROPIN somatropin H01AC Parenteral Within NORDIFLEX - /Solution Guidelines 10 MG/PEN

Patented Drug Products for Human Use Reported to the PMPRB in 2016 99

PMPRB Annual Report 2016

02334879 NORDITROPIN somatropin H01AC Parenteral Within NORDIFLEX - /Solution Guidelines 15 MG/PEN

02265435 NOVOMIX 30 PENFILL insulin aspart/insulin aspart A10AD Parenteral Does Not - 100 UNIT/ protamine /Solution Trigger MILLILITER

02245397 NOVORAPID - insulin aspart A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02377209 NOVORAPID insulin aspart A10AB Parenteral Does Not FLEXTOUCH - /Solution Trigger 100 UNIT/MILLILITER

02244353 NOVORAPID PENFILL insulin aspart A10AB Parenteral Does Not - 100 UNIT/ /Solution Trigger MILLILITER

02437899 SAXENDA - liraglutide A10BX Parenteral Within 6 MG/MILLILITER /Solution Guidelines

02389975 TRETTEN - catridecacog (recombinant B02BD Parenteral Within 15 MG/VIAL coagulation factor xiii /Powder for Guidelines a-subunit) solution

02351064 VICTOZA - liraglutide A10BX Parenteral Does Not 6 MG/MILLILITER /Solution Trigger

Octapharma Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02432951 NUWIQ - antihemophilic factor B02BD Parenteral Introduced Does Not 250 IU/VIAL (recombinant, b-domain /Powder for Trigger deleted), antihemorrhagic solution blood coagulation factor viii

Patented Drug Products for Human Use Reported to the PMPRB in 2016 100

PMPRB Annual Report 2016

02432978 NUWIQ - antihemophilic factor B02BD Parenteral Introduced Does Not 500 IU/VIAL (recombinant, b-domain /Powder for Trigger deleted), antihemorrhagic solution blood coagulation factor viii

02432986 NUWIQ - antihemophilic factor B02BD Parenteral Introduced Under Review 1000 IU/VIAL (recombinant, b-domain /Powder for deleted), antihemorrhagic solution blood coagulation factor viii

02432994 NUWIQ - antihemophilic factor B02BD Parenteral Introduced Under Review 2000 IU/VIAL (recombinant, b-domain /Powder for deleted), antihemorrhagic solution blood coagulation factor viii

Otsuka Canada Pharmaceutical Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02420864 ABILIFY MAINTENA - aripiprazole N05AX Parenteral Within 300 MG/VIAL /Suspensions Guidelines or Emulsions

02420872 ABILIFY MAINTENA - aripiprazole N05AX Parenteral Within 400 MG/VIAL /Suspensions Guidelines or Emulsions

02437538 JINARC tolvaptan C03XA Oral Solid Expired Does Not /Tablet Trigger

02437511 JINARC tolvaptan C03XA Oral Solid Expired Does Not /Tablet Trigger

02437503 JINARC tolvaptan C03XA Oral Solid Expired Does Not /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 101

PMPRB Annual Report 2016

02370468 SAMSCA - tolvaptan C03XA Oral Solid Expired VCU 15 MG/TAB /Tablet

02370476 SAMSCA - tolvaptan C03XA Oral Solid Expired VCU 30 MG/TAB /Tablet

Paladin Labs Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02364174 ABSTRAL - fentanyl citrate N02AB Dental - Does Not 100 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02364182 ABSTRAL - fentanyl citrate N02AB Dental - Within 200 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02364204 ABSTRAL - fentanyl citrate N02AB Dental - Does Not 400 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02364212 ABSTRAL - fentanyl citrate N02AB Dental - Does Not 600 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02364220 ABSTRAL - fentanyl citrate N02AB Dental - Within 800 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 102

PMPRB Annual Report 2016

02242980 ANTIZOL - fomepizole V03AB Parenteral Subj. 1 G/MILLILITER /Solution Investigation

02437333 ICLUSIG - ponatinib L01XE Oral Solid Within 15 MG/TAB /Tablet Guidelines

02437341 ICLUSIG - ponatinib L01XE Oral Solid Introduced Within 45 MG/TAB /Tablet Guidelines

02247698 METADOL - methadone hydrochloride N07BC Oral Solid Within 1 MG/TAB /Tablet Guidelines

02247699 METADOL - methadone hydrochloride N07BC Oral Solid Does Not 5 MG/TAB /Tablet Trigger

02247700 METADOL - methadone hydrochloride N07BC Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02247701 METADOL - methadone hydrochloride N07BC Oral Solid Within 25 MG/TAB /Tablet Guidelines

02280248 TESTIM 1% - testosterone G03BA Topical /Gel Within 5 GM/TUBE Guidelines

02296381 TRIDURAL - tramadol hydrochloride N02AX Oral Solid Does Not 100 MG/TAB /Modified Trigger release tablets

02296403 TRIDURAL - tramadol hydrochloride N02AX Oral Solid Does Not 200 MG/TAB /Modified Trigger release tablets

02296411 TRIDURAL - tramadol hydrochloride N02AX Oral Solid Subj. 300 MG/TAB /Modified Investigation release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 103

PMPRB Annual Report 2016

02411849 VEREGEN - sinecatechins D06BB Topical Does Not 100 MG/GRAM /Ointment Trigger

02388316 XIAFLEX - collagenase clostridium M09AB Parenteral Does Not 0.9 MG/VIAL histolyticum /Powder for Trigger solution

Patriot, A Division Of Janssen Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02316943 PAT-GALANTAMINE galantamine N06DA Oral Solid See Note 1 in ER - 8 MG/CAPSULE hydrobromide /Modified 2016 Annual release Report capsules

02316951 PAT-GALANTAMINE galantamine N06DA Oral Solid See Note 1 in ER - 16 MG/CAPSULE hydrobromide /Modified 2016 Annual release Report capsules

02316978 PAT-GALANTAMINE galantamine N06DA Oral Solid See Note 1 in ER - 24 MG/CAPSULE hydrobromide /Modified 2016 Annual release Report capsules

Pendopharm, Division of Pharmascience Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02330725 VIBATIV - telavancin hydrochloride J01XA Parenteral Introduced Subj. 750 MG/VIAL /Powder for Investigation solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 104

PMPRB Annual Report 2016

Pfizer Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

01947664 ACCUPRIL - quinapril hydrochloride C09AA Oral Solid Does Not 5 MG/TAB /Tablet Trigger

01947672 ACCUPRIL - quinapril hydrochloride C09AA Oral Solid Does Not 10 MG/TAB /Tablet Trigger

01947680 ACCUPRIL - quinapril hydrochloride C09AA Oral Solid Within 20 MG/TAB /Tablet Guidelines

01947699 ACCUPRIL - quinapril hydrochloride C09AA Oral Solid Within 40 MG/TAB /Tablet Guidelines

02237367 ACCURETIC quinapril hydrochloride/ C09BA Oral Solid Within 10/12.5 hydrochlorothiazide /Tablet Guidelines

02237368 ACCURETIC quinapril hydrochloride/ C09BA Oral Solid Within 20/12.5 hydrochlorothiazide /Tablet Guidelines

02237369 ACCURETIC quinapril hydrochloride/ C09BA Oral Solid Within 20/25 hydrochlorothiazide /Tablet Guidelines

02232043 ARICEPT - donepezil hydrochloride N06DA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02232044 ARICEPT - donepezil hydrochloride N06DA Oral Solid Subj. 10 MG/TAB /Tablet Investigation

02269457 ARICEPT RDT - donepezil hydrochloride N06DA Oral Solid Does Not 5 MG/TAB /Tablet Trigger

02269465 ARICEPT RDT - donepezil hydrochloride N06DA Oral Solid Within 10 MG/TAB /Tablet Guidelines

02242705 AROMASIN - exemestane L02BG Oral Solid Does Not 25 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 105

PMPRB Annual Report 2016

02392984 BENEFIX - coagulation factor ix B02BD Parenteral Within 3000 UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293773 BENEFIX - coagulation factor ix B02BD Parenteral Within 500 UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293781 BENEFIX - coagulation factor ix B02BD Parenteral Within 1000 UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293803 BENEFIX - coagulation factor ix B02BD Parenteral Within 2000 UNIT/VIAL (recombinant) /Powder for Guidelines solution

02419149 BOSULIF - bosutinib L01XE Oral Solid Within 100 MG/TAB /Tablet Guidelines

02419157 BOSULIF - bosutinib L01XE Oral Solid Does Not 500 MG/TAB /Tablet Trigger

02273284 CADUET 10/10 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273292 CADUET 10/20 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273306 CADUET 10/40 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273314 CADUET 10/80 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273233 CADUET 5/10 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273241 CADUET 5/20 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 106

PMPRB Annual Report 2016

02273268 CADUET 5/40 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02273276 CADUET 5/80 amlodipine besylate/ C10BX Oral Solid Does Not atorvastatin calcium /Tablet Trigger

02239941 CELEBREX - celecoxib M01AH Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

02239942 CELEBREX - celecoxib M01AH Oral Solid Within 200 MG/CAPSULE /Capsule Guidelines

02291177 CHAMPIX - varenicline tartrate N07BA Oral Solid Within 0.5 MG/TAB /Tablet Guidelines

02291185 CHAMPIX - varenicline tartrate N07BA Oral Solid Within 1 MG/TAB /Tablet Guidelines

02298309 CHAMPIX varenicline tartrate N07BA Oral Solid Within /Tablet Guidelines

02132680 COLESTID - colestipol hydrochloride C10AC Oral Solid Within 1000 MG/TAB /Tablet Guidelines

02132699 COLESTID colestipol hydrochloride C10AC Oral Solid Does Not ORANGE - /Effervescent Trigger 7500 MG/DOSE granules

02239064 DETROL - tolterodine tartrate G04BD Oral Solid Within 1 MG/TAB /Tablet Guidelines

02239065 DETROL - tolterodine tartrate G04BD Oral Solid Within 2 MG/TAB /Tablet Guidelines

02244612 DETROL LA - tolterodine l-tartrate G04BD Oral Solid Does Not 2 MG/CAPSULE /Modified Trigger release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 107

PMPRB Annual Report 2016

02244613 DETROL LA - tolterodine l-tartrate G04BD Oral Solid Within 4 MG/CAPSULE /Modified Guidelines release capsules

02237279 EFFEXOR XR - venlafaxine hydrochloride N06AA Oral Solid Within 37.5 MG/ /Modified Guidelines CAPSULE release capsules

02237280 EFFEXOR XR - venlafaxine hydrochloride N06AA Oral Solid Within 75 MG/CAPSULE /Modified Guidelines release capsules

02237282 EFFEXOR XR - venlafaxine hydrochloride N06AA Oral Solid Within 150 MG/CAPSULE /Modified Guidelines release capsules

02425637 ELELYSO - taliglucerase alfa A16AB Parenteral Within 200 IU/VIAL /Solution Guidelines

02330695 ERAXIS anidulafungin J02AX Parenteral Within (WITHOUT /Powder for Guidelines SOLVENT) - solution 100 MG/VIAL

02401762 GENOTROPIN - somatropin H01AC Parenteral Does Not 0.6 MG/SYRINGE /Powder for Trigger solution

02401770 GENOTROPIN - somatropin H01AC Parenteral Does Not 0.8 MG/SYRINGE /Powder for Trigger solution

02401789 GENOTROPIN - somatropin H01AC Parenteral Does Not 1 MG/SYRINGE /Powder for Trigger solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 108

PMPRB Annual Report 2016

02401797 GENOTROPIN - somatropin H01AC Parenteral Does Not 1.2 MG/SYRINGE /Powder for Trigger solution

02401800 GENOTROPIN - somatropin H01AC Parenteral Does Not 1.4 MG/SYRINGE /Powder for Trigger solution

02401819 GENOTROPIN - somatropin H01AC Parenteral Does Not 1.6 MG/SYRINGE /Powder for Trigger solution

02401827 GENOTROPIN - somatropin H01AC Parenteral Does Not 1.8 MG/SYRINGE /Powder for Trigger solution

02401835 GENOTROPIN - somatropin H01AC Parenteral Within 2 MG/SYRINGE /Powder for Guidelines solution

02401703 GENOTROPIN - somatropin H01AC Parenteral Within 5.3 MG/PEN /Powder for Guidelines solution

02401711 GENOTROPIN - somatropin H01AC Parenteral Subj. 12 MG/PEN /Powder for Investigation solution

02453150 IBRANCE - palbociclib L01XE Oral Solid Introduced Within 75 MG/CAPSULE /Capsule Guidelines

02453169 IBRANCE - palbociclib L01XE Oral Solid Introduced Within 100 MG/CAPSULE /Capsule Guidelines

02453177 IBRANCE - palbociclib L01XE Oral Solid Introduced Within 125 MG/CAPSULE /Capsule Guidelines

02389630 INLYTA - axitinib L01XE Oral Solid Within 1 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 109

PMPRB Annual Report 2016

02389649 INLYTA - axitinib L01XE Oral Solid Within 5 MG/TAB /Tablet Guidelines

02410419 IRINOTECAN - irinotecan hydrochloride L01XX Parenteral Does Not 20 MG/ trihydrate /Solution Trigger MILLILITER

02230711 LIPITOR - atorvastatin calcium C10AA Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02230713 LIPITOR - atorvastatin calcium C10AA Oral Solid Does Not 20 MG/TAB /Tablet Trigger

02230714 LIPITOR - atorvastatin calcium C10AA Oral Solid Does Not 40 MG/TAB /Tablet Trigger

02243097 LIPITOR - atorvastatin calcium C10AA Oral Solid Does Not 80 MG/TAB /Tablet Trigger

02268418 LYRICA - pregabalin N03AX Oral Solid Within 25 MG/CAPSULE /Capsule Guidelines

02268426 LYRICA - pregabalin N03AX Oral Solid Within 50 MG/CAPSULE /Capsule Guidelines

02268434 LYRICA - pregabalin N03AX Oral Solid Within 75 MG/CAPSULE /Capsule Guidelines

02268450 LYRICA - pregabalin N03AX Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

02268477 LYRICA - pregabalin N03AX Oral Solid Within 225 MG/CAPSULE /Capsule Guidelines

02268485 LYRICA - pregabalin N03AX Oral Solid Within 300 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 110

PMPRB Annual Report 2016

02245057 NEISVAC-C meningococcal group c-tt J07AH Parenteral Within conjugate vaccine, adsorbed /Suspensions Guidelines or Emulsions

02084260 NEURONTIN - gabapentin N03AX Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

02084279 NEURONTIN - gabapentin N03AX Oral Solid Does Not 300 MG/CAPSULE /Capsule Trigger

02084287 NEURONTIN - gabapentin N03AX Oral Solid Does Not 400 MG/CAPSULE /Capsule Trigger

02239717 NEURONTIN - gabapentin N03AX Oral Solid Within 600 MG/TAB /Tablet Guidelines

02239718 NEURONTIN - gabapentin N03AX Oral Solid Within 800 MG/TAB /Tablet Guidelines

02402904 NIMENRIX - meningococcal polysaccharide J07AH Parenteral Does Not 5 MCG/DOSE groups a, c, w-135 and y conjugate /Powder for Trigger solution

00878928 NORVASC - amlodipine besylate C08CA Oral Solid Within 5 MG/TAB /Tablet Guidelines

00878936 NORVASC - amlodipine besylate C08CA Oral Solid Subj. 10 MG/TAB /Tablet Investigation

02335204 PREVNAR 13 pneumococcal 13-valent conjugate J07AL Parenteral Within vaccine (diphtheria crm197 /Suspensions Guidelines protein) or Emulsions

02321092 PRISTIQ - desvenlafaxine succinate N06AX Oral Solid Subj. 50 MG/TAB /Modified Investigation release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 111

PMPRB Annual Report 2016

02321106 PRISTIQ - desvenlafaxine succinate N06AX Oral Solid Subj. 100 MG/TAB /Modified Investigation release tablets

02243237 RAPAMUNE - sirolimus L04AA Oral Liquid Does Not 1 MG/MILLILITER /Solution Trigger

02247111 RAPAMUNE - sirolimus L04AA Oral Solid Within 1 MG/TAB /Tablet Guidelines

02279401 REVATIO - sildenafil citrate G04BE Oral Solid Within 20 MG/TAB /Tablet Guidelines

02341611 REVATIO IV - sildenafil citrate G04BE Parenteral Does Not 0.8 MG/ /Solution Trigger MILLILITER

02272199 SOMAVERT - pegvisomant H01AX Parenteral Within 10 MG/VIAL /Powder for Guidelines solution

02272202 SOMAVERT - pegvisomant H01AX Parenteral Within 15 MG/VIAL /Powder for Guidelines solution

02272210 SOMAVERT - pegvisomant H01AX Parenteral Within 20 MG/VIAL /Powder for Guidelines solution

02448831 SOMAVERT - pegvisomant H01AX Parenteral Introduced Within 25 MG/VIAL /Powder for Guidelines solution

02448858 SOMAVERT - pegvisomant H01AX Parenteral Introduced Within 30 MG/VIAL /Powder for Guidelines solution

02280795 SUTENT - sunitinib malate L01XE Oral Solid Within 12.5 MG/ /Capsule Guidelines CAPSULE

Patented Drug Products for Human Use Reported to the PMPRB in 2016 112

PMPRB Annual Report 2016

02280809 SUTENT - sunitinib malate L01XE Oral Solid Within 25 MG/CAPSULE /Capsule Guidelines

02280817 SUTENT - sunitinib malate L01XE Oral Solid Within 50 MG/CAPSULE /Capsule Guidelines

02304104 TORISEL - temsirolimus L01XE Parenteral Within 25 MG/VIAL /Solution Guidelines

02380021 TOVIAZ - fesoterodine fumarate G04BD Oral Solid Within 4 MG/TAB /Modified Guidelines release tablets

02380048 TOVIAZ - fesoterodine fumarate G04BD Oral Solid Within 8 MG/TAB /Modified Guidelines release tablets

02285401 TYGACIL - tigecycline J01AA Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02279991 VFEND - voriconazole J02AC Oral Liquid Does Not 40 MG/ /Powder for Trigger MILLILITER suspension

02256460 VFEND - voriconazole J02AC Oral Solid Does Not 50 MG/TAB /Tablet Trigger

02256479 VFEND - voriconazole J02AC Oral Solid Subj. 200 MG/TAB /Tablet Investigation

02256487 VFEND - voriconazole J02AC Parenteral Within 200 MG/VIAL /Powder for Guidelines solution

02239766 VIAGRA - sildenafil citrate G04BE Oral Solid Within 25 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 113

PMPRB Annual Report 2016

02239767 VIAGRA - sildenafil citrate G04BE Oral Solid Within 50 MG/TAB /Tablet Guidelines

02239768 VIAGRA - sildenafil citrate G04BE Oral Solid Within 100 MG/TAB /Tablet Guidelines

02384256 XALKORI - crizotinib L01XE Oral Solid VCU 200 MG/CAPSULE /Capsule

02384264 XALKORI - crizotinib L01XE Oral Solid VCU 250 MG/CAPSULE /Capsule

02423898 XELJANZ - tofacitinib L04AA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02309483 XYNTHA - moroctocog alpha B02BD Parenteral Within 250 UNIT/VIAL /Powder for Guidelines solution

02309491 XYNTHA - moroctocog alpha B02BD Parenteral Within 500 UNIT/VIAL /Powder for Guidelines solution

02374072 XYNTHA moroctocog alpha B02BD Parenteral Within SOLOFUSE - /Powder for Guidelines 1000 UNIT/ solution SYRINGE

02374080 XYNTHA moroctocog alpha B02BD Parenteral Within SOLOFUSE - /Powder for Guidelines 2000 UNIT/ solution SYRINGE

02374099 XYNTHA moroctocog alpha B02BD Parenteral Within SOLOFUSE - /Powder for Guidelines 3000 UNIT/ solution SYRINGE

02298597 ZELDOX - ziprasidone hydrochloride N05AE Oral Solid Does Not 20 MG/CAPSULE /Capsule Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 114

PMPRB Annual Report 2016

02298600 ZELDOX - ziprasidone hydrochloride N05AE Oral Solid Does Not 40 MG/CAPSULE /Capsule Trigger

02298619 ZELDOX - ziprasidone hydrochloride N05AE Oral Solid Does Not 60 MG/CAPSULE /Capsule Trigger

02298627 ZELDOX - ziprasidone hydrochloride N05AE Oral Solid Does Not 80 MG/CAPSULE /Capsule Trigger

02223716 ZITHROMAX - azithromycin J01FA Oral Liquid Within 20 MG/ /Powder for Guidelines MILLILITER suspension

02223724 ZITHROMAX - azithromycin J01FA Oral Liquid Within 40 MG/ /Powder for Guidelines MILLILITER suspension

02212021 ZITHROMAX - azithromycin J01FA Oral Solid Within 250 MG/TAB /Tablet Guidelines

02239952 ZITHROMAX - azithromycin J01FA Parenteral Subj. 500 MG/VIAL /Powder for Investigation solution

02132702 ZOLOFT - sertraline hydrochloride N06AB Oral Solid Within 25 MG/CAPSULE /Capsule Guidelines

01962817 ZOLOFT - sertraline hydrochloride N06AB Oral Solid Within 50 MG/CAPSULE /Capsule Guidelines

01962779 ZOLOFT - sertraline hydrochloride N06AB Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

02243686 ZYVOXAM - linezolid J01XX Oral Liquid Does Not 20 MG/ /Powder for Trigger MILLILITER suspension

02243684 ZYVOXAM - linezolid J01XX Oral Solid Within 600 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 115

PMPRB Annual Report 2016

02243685 ZYVOXAM - linezolid J01XX Parenteral Within 2 MG/MILLILITER /Solution Guidelines

Pharmascience Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02406764 CYTARABINE - cytarabine L01BC Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02406772 CYTARABINE - cytarabine L01BC Parenteral Within 100 MG/MILLILITER /Solution Guidelines

PTC Therapeutics International Limited

DIN Brand Name Chemical Name ATC Dosage Comments Status

TRANSLARNA - ataluren M09AX Oral Solid Within 250 MG/POUCH /Effervescent Guidelines granules

TRANSLARNA - ataluren M09AX Oral Solid Introduced Within 1000 MG/POUCH /Effervescent Guidelines granules

Purdue Pharma

DIN Brand Name Chemical Name ATC Dosage Comments Status

02277166 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 10 MG/CAPSULE /Modified Guidelines release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 116

PMPRB Annual Report 2016

02277131 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 15 MG/CAPSULE /Modified Guidelines release capsules

02277158 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 20 MG/CAPSULE /Modified Guidelines release capsules

02277174 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 30 MG/CAPSULE /Modified Guidelines release capsules

02277182 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 40 MG/CAPSULE /Modified Guidelines release capsules

02277190 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 50 MG/CAPSULE /Modified Guidelines release capsules

02277204 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 60 MG/CAPSULE /Modified Guidelines release capsules

02277212 BIPHENTIN - methylphenidate hydrochloride N06BA Oral Solid Within 80 MG/CAPSULE /Modified Guidelines release capsules

02450771 BUTRANS - buprenorphine N02AE Topical Introduced Under Review 15 MG/PATCH /Patches

02341212 BUTRANS 10 - buprenorphine N02AE Topical Within 10 MG/PATCH /Patches Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 117

PMPRB Annual Report 2016

02341220 BUTRANS 20 - buprenorphine N02AE Topical Within 20 MG/PATCH /Patches Guidelines

02341174 BUTRANS 5 - buprenorphine N02AE Topical Within 5 MG/PATCH /Patches Guidelines

02231934 OXY-IR - oxycodone hydrochloride N02AA Oral Solid Within 5 MG/TAB /Tablet Guidelines

02240131 OXY-IR - oxycodone hydrochloride N02AA Oral Solid Within 10 MG/TAB /Tablet Guidelines

02240132 OXY-IR - oxycodone hydrochloride N02AA Oral Solid Within 20 MG/TAB /Tablet Guidelines

02372525 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 10 MG/TAB /Modified Guidelines release tablets

02372533 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 15 MG/TAB /Modified Guidelines release tablets

02372797 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 20 MG/TAB /Modified Guidelines release tablets

02372541 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 30 MG/TAB /Modified Guidelines release tablets

02372568 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 40 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 118

PMPRB Annual Report 2016

02372576 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 60 MG/TAB /Modified Guidelines release tablets

02372584 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 80 MG/TAB /Modified Guidelines release tablets

02339609 TARGIN 10/5 oxycodone hydrochloride / N02AA Oral Solid Within naloxone hydrochloride /Modified Guidelines release tablets

02339617 TARGIN 20/10 oxycodone hydrochloride / N02AA Oral Solid Within naloxone hydrochloride /Modified Guidelines release tablets

02339625 TARGIN 40/20 oxycodone hydrochloride / N02AA Oral Solid Within naloxone hydrochloride /Modified Guidelines release tablets

02387425 TARGIN 5/2.5 oxycodone hydrochloride / N02AA Oral Solid Does Not naloxone hydrochloride /Modified Trigger release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 119

PMPRB Annual Report 2016

Ranbaxy Pharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02305038 RAN-PANTOPRAZOLE pantoprazole sodium A02BC Oral Solid See Note 1 in - 20 MG/TAB /Tablet 2016 Annual Report

02305046 RAN-PANTOPRAZOLE pantoprazole sodium A02BC Oral Solid See Note 1 in - 40 MG/TAB /Tablet 2016 Annual Report

Sandoz Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02246533 ANGIOMAX - bivalirudin B01AE Parenteral Within 250 MG/VIAL /Powder for Guidelines solution

Sanofi Pasteur Limited

DIN Brand Name Chemical Name ATC Dosage Comments Status

02240255 ADACEL dapt vaccine J07AJ Parenteral Expired Subj. /Suspensions Investigation or Emulsions

02352044 ADACEL-POLIO dapt-ipv vaccine J07CA Parenteral Expired Does Not /Suspensions Trigger or Emulsions

02279924 MENACTRA diphteria toxoid/ J07AH Parenteral Within meningococcal polysach. /Solution Guidelines conj. vaccine

Patented Drug Products for Human Use Reported to the PMPRB in 2016 120

PMPRB Annual Report 2016

02243167 PEDIACEL dapt-ipv-hib vaccine J07CA Parenteral Expired Within /Solution Guidelines

Sanofi-Aventis Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02254506 ALDURAZYME - laronidase A16AB Parenteral Within 0.58 MG/MILLILITER /Solution Guidelines

02279460 APIDRA - insulin glulisine A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02279479 APIDRA - insulin glulisine A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02294346 APIDRA SOLOSTAR - insulin glulisine A10AB Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02241888 ARAVA - leflunomide L04AA Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02241889 ARAVA - leflunomide L04AA Oral Solid Does Not 20 MG/TAB /Tablet Trigger

02241818 AVALIDE 150/12.5 irbesartan/hydrochloroth C09DA Oral Solid Within iazide /Tablet Guidelines

02241819 AVALIDE 300/12.5 irbesartan/hydrochloroth C09DA Oral Solid Within iazide /Tablet Guidelines

02237923 AVAPRO - irbesartan C09CA Oral Solid Within 75 MG/TAB /Tablet Guidelines

02237924 AVAPRO - irbesartan C09CA Oral Solid Within 150 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 121

PMPRB Annual Report 2016

02237925 AVAPRO - irbesartan C09CA Oral Solid Within 300 MG/TAB /Tablet Guidelines

02378582 CAPRELSA - vandetanib L01XE Oral Solid Within 100 MG/TAB /Tablet Guidelines

02378590 CAPRELSA - vandetanib L01XE Oral Solid Within 300 MG/TAB /Tablet Guidelines

02330407 CLOLAR - clofarabine L01BB Parenteral Within 20 MG/VIAL /Solution Guidelines

02248239 ELIGARD - leuprolide acetate L02AE Parenteral Within 7.5 MG/VIAL /Solution Guidelines

02248240 ELIGARD - leuprolide acetate L02AE Parenteral Within 22.5 MG/VIAL /Solution Guidelines

02248999 ELIGARD - leuprolide acetate L02AE Parenteral Within 30 MG/VIAL /Solution Guidelines

02268892 ELIGARD - leuprolide acetate L02AE Parenteral Within 45 MG/VIAL /Solution Guidelines

02296284 ELOXATIN - oxaliplatine L01XA Parenteral Within 5 MG/MILLILITER /Solution Guidelines

02248416 FASTURTEC - rasburicase V03AF Parenteral Expired Within 1.5 MG/VIAL /Powder for Guidelines solution

FUMAGILLINE - fumagilline P01AX Oral Solid Expired Within 20 MG/CAPSULE /Capsule Guidelines

02369524 JEVTANA - cabazitaxel L01CD Parenteral Within 60 MG/VIAL /Solution Guidelines

02245689 LANTUS - insulin glargine A10AE Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 122

PMPRB Annual Report 2016

02251930 LANTUS - insulin glargine A10AE Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02294338 LANTUS SOLOSTAR - insulin glargine A10AE Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

02377225 MOZOBIL - plerixafor L03AX Parenteral Within 20 MG/MILLILITER /Solution Guidelines

02330989 MULTAQ - dronedarone C01BD Oral Solid Within 400 MG/TAB hydrochloride /Tablet Guidelines

02284863 MYOZYME - alglucosidase alfa A16AB Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02238682 PLAVIX - clopidogrel bisulfate B01AC Oral Solid Within 75 MG/TAB /Tablet Guidelines

02330555 PLAVIX - clopidogrel bisulfate B01AC Oral Solid Within 300 MG/TAB /Tablet Guidelines

02244310 RENAGEL - sevelamer hydrochloride V03AE Oral Solid Within 800 MG/TAB /Tablet Guidelines

02354586 RENVELA - sevelamer carbonate V03AE Oral Solid Within 800 MG/TAB /Tablet Guidelines

02441829 TOUJEO SOLOSTAR - insulin glargine A10AE Parenteral Within 300 UNIT/MILLILITER /Solution Guidelines

02245565 XATRAL - 10 MG/TAB alfuzosin hydrochloride G04CA Oral Solid Within /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 123

PMPRB Annual Report 2016

Seattle Genetics Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02401347 ADCETRIS - brentuximab vedotin L01XC Parenteral - Within 50 MG/VIAL Powder for Guidelines solution

Servier Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02123274 COVERSYL - perindopril erbumine C09AA Oral Solid Within 2 MG/TAB /Tablet Guidelines

02123282 COVERSYL - perindopril erbumine C09AA Oral Solid Within 4 MG/TAB /Tablet Guidelines

02246624 COVERSYL - perindopril erbumine C09AA Oral Solid Within 8 MG/TAB /Tablet Guidelines

02246569 COVERSYL PLUS perindopril C09BA Oral Solid Within 4/1.25 erbumine/indapamide /Tablet Guidelines

02321653 COVERSYL PLUS perindopril C09BA Oral Solid Within HD 8/2.5 erbumine/indapamide /Tablet Guidelines

02246568 COVERSYL PLUS perindopril C09BA Oral Solid Within LD 2/0.625 erbumine/indapamide /Tablet Guidelines

02242987 DIAMICRON MR - gliclazide A10BB Oral Solid Within 30 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 124

PMPRB Annual Report 2016

02356422 DIAMICRON MR - gliclazide A10BB Oral Solid Within 60 MG/TAB /Modified Guidelines release tablets

02451557 VIACORAM 14/10 perindopril arginine / C09BB Oral Solid Introduced Within amlodipine /Tablet Guidelines

02451530 VIACORAM 3.5/2.5 perindopril arginine / C09BB Oral Solid Introduced Within amlodipine /Tablet Guidelines

02451549 VIACORAM 7/5 perindopril arginine / C09BB Oral Solid Introduced Within amlodipine /Tablet Guidelines

Shire Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02248808 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 5 MG/CAPSULE /Modified Guidelines release capsules

02248809 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 10 MG/CAPSULE /Modified Guidelines release capsules

02248810 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 15 MG/CAPSULE /Modified Guidelines release capsules

02248811 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 20 MG/CAPSULE /Modified Guidelines release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 125

PMPRB Annual Report 2016

02248812 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 25 MG/CAPSULE /Modified Guidelines release capsules

02248813 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 30 MG/CAPSULE /Modified Guidelines release capsules

02287145 FOSRENOL - lanthanum carbonate V03AE Oral Solid Within 250 MG/TAB hydrate /Tablet Guidelines

02287153 FOSRENOL - lanthanum carbonate V03AE Oral Solid Within 500 MG/TAB hydrate /Tablet Guidelines

02287161 FOSRENOL - lanthanum carbonate V03AE Oral Solid Within 750 MG/TAB hydrate /Tablet Guidelines

02287188 FOSRENOL - lanthanum carbonate V03AE Oral Solid Within 1000 MG/TAB hydrate /Tablet Guidelines

02409100 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Within 1 MG/TAB /Modified Guidelines release tablets

02409119 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Subj. 2 MG/TAB /Modified Investigation release tablets

02409127 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Subj. 3 MG/TAB /Modified Investigation release tablets

02409135 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Subj. 4 MG/TAB /Modified Investigation release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 126

PMPRB Annual Report 2016

02297558 MEZAVANT - mesalamine A07EC Oral Solid Does Not 1.2 G/TAB /Modified Trigger release tablets

02445727 REVESTIVE - teduglutide A16AX Oral Liquid Within 5 MG/VIAL /Powder for Guidelines solution

02439603 VYVANSE - lisdexamfetamine N06BA Oral Solid Subj. 10 MG/CAPSULE dimesylate /Capsule Investigation

02347156 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 20 MG/CAPSULE dimesylate /Capsule Guidelines

02322951 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 30 MG/CAPSULE dimesylate /Capsule Guidelines

02347164 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 40 MG/CAPSULE dimesylate /Capsule Guidelines

02322978 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 50 MG/CAPSULE dimesylate /Capsule Guidelines

02347172 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 60 MG/CAPSULE dimesylate /Capsule Guidelines

Shire Human Genetic Therapies, Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

See REPLAGAL - agalsidase alfa A16AB Parenteral Within Note 3 3.5 MG/VIAL /Solution Guidelines

02357119 VPRIV - velaglucerase alfa A16AB Parenteral Within 400 UNIT/VIAL /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 127

PMPRB Annual Report 2016

Shire Orphan Therapies, Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02425696 FIRAZYR - icatibant acetate C01EB Parenteral Expired Does Not 10 MG/MILLILITER /Solution Trigger

Sunovion Pharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02426862 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 200 MG/TAB /Tablet Guidelines

02426870 APTIOM - eslicarbazepine acetate N03AF Oral Solid Does Not 400 MG/TAB /Tablet Trigger

02426889 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 600 MG/TAB /Tablet Guidelines

02426897 APTIOM - eslicarbazepine acetate N03AF Oral Solid Does Not 800 MG/TAB /Tablet Trigger

02299909 CUBICIN - daptomycin J01XX Parenteral Within 500 MG/VIAL /Powder for Guidelines solution

02422050 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 20 MG/TAB /Tablet Guidelines

02387751 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 40 MG/TAB /Tablet Guidelines

02413361 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 60 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 128

PMPRB Annual Report 2016

02387778 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 80 MG/TAB /Tablet Guidelines

02387786 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 120 MG/TAB /Tablet Guidelines

02262347 NIASPAN - niacin C10AD Oral Solid Within 500 MG/TAB /Modified Guidelines release tablets

02262339 NIASPAN - niacin C10AD Oral Solid Within 1000 MG/TAB /Modified Guidelines release tablets

02309254 NIASPAN FCT - niacin C10AD Oral Solid Within 500 MG/TAB /Modified Guidelines release tablets

02309262 NIASPAN FCT - niacin C10AD Oral Solid Within 750 MG/TAB /Modified Guidelines release tablets

02309289 NIASPAN FCT - niacin C10AD Oral Solid Within 1000 MG/TAB /Modified Guidelines release tablets

Swedish Orphan Biovitrum, SOBI AB

DIN Brand Name Chemical Name ATC Dosage Comments Status

02245913 KINERET - anakinra L04AA Parenteral Within 100 MG/SYRINGE /Solution Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 129

PMPRB Annual Report 2016

Takeda Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02242572 ACTOS - 15 MG/TAB pioglitazone A10BG Oral Solid Within hydrochloride /Tablet Guidelines

02242573 ACTOS - 30 MG/TAB pioglitazone A10BG Oral Solid Within hydrochloride /Tablet Guidelines

02242574 ACTOS - 45 MG/TAB pioglitazone A10BG Oral Solid Within hydrochloride /Tablet Guidelines

02285606 ALVESCO - ciclesonide R03BA Pulmonary Within 100 MCG/DOSE /Metered Guidelines dose preparations

02285614 ALVESCO - ciclesonide R03BA Pulmonary Within 200 MCG/DOSE /Metered Guidelines dose preparations

02359456 DAXAS - roflumilast R03DX Oral Solid Within 500 MCG/TAB /Tablet Guidelines

02354950 DEXILANT - dexlansoprazole A02BC Oral Solid Within 30 MG/CAPSULE /Capsule Guidelines

02354969 DEXILANT - dexlansoprazole A02BC Oral Solid Within 60 MG/CAPSULE /Capsule Guidelines

02436841 ENTYVIO - vedolizumab L04AA Parenteral Within 300 MG/VIAL /Powder for Guidelines solution

02417235 KAZANO 12.5/1000 alogliptin benzoate / A10BD Oral Solid Within metformin hydrochloride /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 130

PMPRB Annual Report 2016

02417219 KAZANO 12.5/500 alogliptin benzoate / A10BD Oral Solid Within metformin hydrochloride /Tablet Guidelines

02417227 KAZANO 12.5/850 alogliptin benzoate / A10BD Oral Solid Does Not metformin hydrochloride /Tablet Trigger

02417189 NESINA - alogliptin benzoate A10BH Oral Solid Within 6.25 MG/TAB /Tablet Guidelines

02417197 NESINA - alogliptin benzoate A10BH Oral Solid Within 12.5 MG/TAB /Tablet Guidelines

02417200 NESINA - alogliptin benzoate A10BH Oral Solid Within 25 MG/TAB /Tablet Guidelines

02456796 NINLARO - ixazomib citrate L01XX Oral Introduced Under Review 2.3 MG/CAP Solid/Capsule

02456818 NINLARO - ixazomib citrate L01XX Oral Introduced Under Review 3 MG/CAP Solid/Capsule

02456826 NINLARO - ixazomib citrate L01XX Oral Introduced Under Review 4 MG/CAP Solid/Capsule

02303671 OMNARIS - ciclesonide R03BA Nasal Within 50 MCG/DOSE /Metered Guidelines dose preparations

02239616 PANTO IV - pantoprazole sodium A02BC Parenteral Within 40 MG/VIAL /Powder for Guidelines solution

02229453 PANTOLOC - pantoprazole sodium A02BC Oral Solid Does Not 40 MG/TAB /Tablet Trigger

02241804 PANTOLOC - pantoprazole sodium A02BC Oral Solid Does Not 20 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 131

PMPRB Annual Report 2016

02439042 TACHOSIL 2/5.5/2.1 thrombin, fibrinogen, B02BB Topical Within collagen /Patches Guidelines

02267233 TECTA - pantoprazole magnesium A02BC Oral Solid Within 40 MG/TAB /Tablet Guidelines

02357380 ULORIC - febuxostat M04AA Oral Solid Within 80 MG/TAB /Tablet Guidelines

Teva Canada Innovation G.P.-S.E.N.C.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02284642 AZILECT - rasagiline mesylate N04BD Oral Solid Expired Within 0.5 MG/TAB /Tablet Guidelines

02284650 AZILECT - rasagiline mesylate N04BD Oral Solid Expired Within 1 MG/TAB /Tablet Guidelines

02245619 COPAXONE - glatiramer acetate L03AX Parenteral Within 20 MG/SYRINGE /Solution Guidelines

02456915 COPAXONE - glatiramer acetate L03AX Parenteral Introduced Under Review 40 MG/MILLILITER /Solution

02408007 FENTORA - fentanyl citrate N02AB Dental - Within 100 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02408015 FENTORA - fentanyl citrate N02AB Dental - Within 200 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 132

PMPRB Annual Report 2016

02408023 FENTORA - fentanyl citrate N02AB Dental - Within 400 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02408031 FENTORA - fentanyl citrate N02AB Dental - Does Not 600 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02408058 FENTORA - fentanyl citrate N02AB Dental - Within 800 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

Theratechnologies Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02438712 EGRIFTA - 1 MG/VIAL tesamorelin H01AC Parenteral Does Not /Powder for Trigger solution

Tribute Pharmaceuticals Canada Ltd.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02381680 CAMBIA - diclofenac potassium M01AB Oral Liquid Within 50 MG/POUCH /Powder for Guidelines solution

Patented Drug Products for Human Use Reported to the PMPRB in 2016 133

PMPRB Annual Report 2016

UCB Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02452936 BRIVLERA - brivaracetam N03AX Oral Solid Introduced Within 10 MG/TAB /Tablet Guidelines

02452944 BRIVLERA - brivaracetam N03AX Oral Solid Introduced Within 25 MG/TAB /Tablet Guidelines

02452952 BRIVLERA - brivaracetam N03AX Oral Solid Introduced Within 50 MG/TAB /Tablet Guidelines

02452960 BRIVLERA - brivaracetam N03AX Oral Solid Introduced Within 75 MG/TAB /Tablet Guidelines

02452979 BRIVLERA - brivaracetam N03AX Oral Solid Introduced Within 100 MG/TAB /Tablet Guidelines

02331675 CIMZIA - certolizumab pegol L04AB Parenteral Within 200 MG/MILLILITER /Powder for Guidelines solution

02247027 KEPPRA - levetiracetam N03AX Oral Solid Within 250 MG/TAB /Tablet Guidelines

02247028 KEPPRA - levetiracetam N03AX Oral Solid Within 500 MG/TAB /Tablet Guidelines

02247029 KEPPRA - levetiracetam N03AX Oral Solid Within 750 MG/TAB /Tablet Guidelines

02403897 NEUPRO - rotigotine N04BC Topical Within 1 MG/PATCH /Patches Guidelines

02403900 NEUPRO - rotigotine N04BC Topical Within 2 MG/PATCH /Patches Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 134

PMPRB Annual Report 2016

02403919 NEUPRO - rotigotine N04BC Topical Within 3 MG/PATCH /Patches Guidelines

02403927 NEUPRO - rotigotine N04BC Topical Within 4 MG/PATCH /Patches Guidelines

02403935 NEUPRO - rotigotine N04BC Topical Within 6 MG/PATCH /Patches Guidelines

02403943 NEUPRO - rotigotine N04BC Topical Within 8 MG/PATCH /Patches Guidelines

02357615 VIMPAT - lacosamide N03AX Oral Solid Does Not 50 MG/TAB /Tablet Trigger

02357623 VIMPAT - lacosamide N03AX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02357631 VIMPAT - lacosamide N03AX Oral Solid Within 150 MG/TAB /Tablet Guidelines

02357658 VIMPAT - lacosamide N03AX Oral Solid Within 200 MG/TAB /Tablet Guidelines

02357666 VIMPAT - lacosamide N03AX Parenteral Does Not 10 MG/MILLILITER /Solution Trigger

Valeant Canada LP

DIN Brand Name Chemical Name ATC Dosage Comments Status

02281074 ACZONE - dapsone D10AX Topical /Gel Does Not 50 MG/GRAM Trigger

02221829 ALTACE - ramipril C09AA Oral Solid Expired Within 1.25 MG/CAPSULE /Capsule Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 135

PMPRB Annual Report 2016

02221837 ALTACE - ramipril C09AA Oral Solid Expired Within 2.5 MG/CAPSULE /Capsule Guidelines

02221845 ALTACE - ramipril C09AA Oral Solid Expired Within 5 MG/CAPSULE /Capsule Guidelines

02221853 ALTACE - ramipril C09AA Oral Solid Expired Within 10 MG/CAPSULE /Capsule Guidelines

02281112 ALTACE - ramipril C09AA Oral Solid Expired Does Not 15 MG/CAPSULE /Capsule Trigger

02283166 ALTACE HCT 10/12.5 ramipril/hydrochlorothiazide C09BA Oral Solid Expired Within /Tablet Guidelines

02283182 ALTACE HCT 10/25 ramipril/hydrochlorothiazide C09BA Oral Solid Expired Within /Tablet Guidelines

02283131 ALTACE HCT ramipril/hydrochlorothiazide C09BA Oral Solid Expired Does Not 2.5/12.5 /Tablet Trigger

02283158 ALTACE HCT 5/12.5 ramipril/hydrochlorothiazide C09BA Oral Solid Expired Does Not /Tablet Trigger

02283174 ALTACE HCT 5/25 ramipril/hydrochlorothiazide C09BA Oral Solid Expired Subj. /Tablet Investigation

02336847 BESIVANCE - besifloxacin S01AX Ophthalmic Within 6 MG/MILLILITER /Suspension Guidelines

02359685 BIACNA 1.2/0.025 clindamycin D10AF Topical /Gel Does Not phosphate/tretinoin Trigger

02381389 EDARBI - azilsartan medoxomil C09CA Oral Solid Within 40 MG/TAB /Tablet Guidelines

02381397 EDARBI - azilsartan medoxomil C09CA Oral Solid Does Not 80 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 136

PMPRB Annual Report 2016

02397749 EDARBYCLOR azilsartan C09DA Oral Solid Within 40/12.5 medoxomil/chlorthalidone /Tablet Guidelines

02397765 EDARBYCLOR 40/25 azilsartan C09DA Oral Solid Within medoxomil/chlorthalidone /Tablet Guidelines

02247238 ELIDEL - pimecrolimus D11AX Topical Within 10 MG/GRAM /Cream Guidelines

02268493 GLUMETZA - metformin hydrochloride A10BA Oral Solid Within 500 MG/TAB /Modified Guidelines release tablets

02300451 GLUMETZA - metformin hydrochloride A10BA Oral Solid Within 1000 MG/TAB /Modified Guidelines release tablets

02413388 JUBLIA - efinaconazole D01AC Topical Subj. 100 MG/GRAM /Liquid Investigation

02373955 LODALIS - colesevelam hydrochloride C10AC Oral Solid Within 625 MG/TAB /Tablet Guidelines

02432463 LODALIS - colesevelam hydrochloride C10AC Parenteral Does Not 3.75 G/DOSE /Powder for Trigger solution

02133326 MIOCHOL-E - acetylcholine chloride S01EB Ophthalmic Within 20 MG/VIAL /Powder for Guidelines solution

02125226 NIDAGEL - metronidazole G01AF Vaginal /Gel Does Not 7.5 MG/GRAM Trigger

02299194 RALIVIA - tramadol hydrochloride N02AX Oral Solid Within 100 MG/TAB /Modified Guidelines release tablets

Patented Drug Products for Human Use Reported to the PMPRB in 2016 137

PMPRB Annual Report 2016

02299208 RALIVIA - tramadol hydrochloride N02AX Oral Solid Within 200 MG/TAB /Modified Guidelines release tablets

02299216 RALIVIA - tramadol hydrochloride N02AX Oral Solid Within 300 MG/TAB /Modified Guidelines release tablets

02306980 RETISERT - fluocinolone acetonide S01BA Ophthalmic Subj. 0.59 MG/IMPLANT /Modified Investigation release ocular devices

02391678 SUBLINOX - zolpidem tartrate N05CF Dental - Does Not 5 MG/TAB Sublingual Trigger Buccal /Sublingual tablets

02370433 SUBLINOX - zolpidem tartrate N05CF Dental - Does Not 10 MG/TAB Sublingual Trigger Buccal /Sublingual tablets

See TESTRED - methyltestosterone G03BA Oral Solid Does Not Note 3 10 MG/CAPSULE /Capsule Trigger

02231150 TIAZAC - diltiazem hydrochloride C08DB Oral Solid Expired Within 120 MG/CAPSULE /Modified Guidelines release capsules

02231151 TIAZAC - diltiazem hydrochloride C08DB Oral Solid Expired Within 180 MG/CAPSULE /Modified Guidelines release capsules

Patented Drug Products for Human Use Reported to the PMPRB in 2016 138

PMPRB Annual Report 2016

02231152 TIAZAC - diltiazem hydrochloride C08DB Oral Solid Expired Does Not 240 MG/CAPSULE /Modified Trigger release capsules

02231154 TIAZAC - diltiazem hydrochloride C08DB Oral Solid Expired Does Not 300 MG/CAPSULE /Modified Trigger release capsules

02231155 TIAZAC - diltiazem hydrochloride C08DB Oral Solid Expired Within 360 MG/CAPSULE /Modified Guidelines release capsules

02256738 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Expired Within 120 MG/TAB /Modified Guidelines release tablets

02256746 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Expired Within 180 MG/TAB /Modified Guidelines release tablets

02256754 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Expired Within 240 MG/TAB /Modified Guidelines release tablets

02256762 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Expired Within 300 MG/TAB /Modified Guidelines release tablets

02256770 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Expired Within 360 MG/TAB /Modified Guidelines release tablets

02365561 VYLOMA - imiquimod D06BB Topical Does Not 3 MG/POUCH /Cream Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 139

PMPRB Annual Report 2016

02275090 WELLBUTRIN XL - bupropion hydrochloride N07BA Oral Solid Within 150 MG/TAB /Modified Guidelines release tablets

02275104 WELLBUTRIN XL - bupropion hydrochloride N07BA Oral Solid Within 300 MG/TAB /Modified Guidelines release tablets

02404044 XERESE 50/10 acyclovir 5%/ D06BB Topical Does Not hydrocortisone 1% /Cream Trigger

02268272 XYREM - sodium oxybate N07XX Oral Liquid Within 500 MG/MILLILITER /Solution Guidelines

02340445 ZYCLARA - imiquimod D06BB Topical Does Not 250 MG/POUCH /Cream Trigger

Valneva Austria GMBH

DIN Brand Name Chemical Name ATC Dosage Comments Status

02333279 IXIARO - japanese encephalitis J07BA Parenteral Within 6 MCG/DOSE vaccine (inactivated, /Suspensions Guidelines adsorbed) or Emulsions

Vertex Pharmaceuticals Canada Inc.

DIN Brand Name Chemical Name ATC Dosage Comments Status

02397412 KALYDECO - ivacaftor R07AX Oral Solid Within 150 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 140

PMPRB Annual Report 2016

02442612 KALYDECO - ivacaftor R07AX Oral Solid Within 50 MG/PACK /Effervescent Guidelines granules

02442620 KALYDECO - ivacaftor R07AX Oral Solid Within 75 MG/PACK /Effervescent Guidelines granules

02451379 ORKAMBI 200/125 lumacaftor / ivacaftor R07AX Oral Solid Introduced Within /Tablet Guidelines

VIIV Healthcare ULC

DIN Brand Name Chemical Name ATC Dosage Comments Status

02192691 3TC - 10 MG/ lamivudine J05AF Oral Liquid Within MILLILITER /Solution Guidelines

02192683 3TC - 150 MG/TAB lamivudine J05AF Oral Solid Does Not /Tablet Trigger

02247825 3TC - 300 MG/TAB lamivudine J05AF Oral Solid Within /Tablet Guidelines

02299844 CELSENTRI - maraviroc J05AX Oral Solid Does Not 150 MG/TAB /Tablet Trigger

02299852 CELSENTRI - maraviroc J05AX Oral Solid Does Not 300 MG/TAB /Tablet Trigger

02239213 COMBIVIR 150/300 lamivudine/ zidovudine J05AF Oral Solid Within /Tablet Guidelines

02269341 KIVEXA 300/600 abacavir J05AF Oral Solid Within sulfate/lamivudine /Tablet Guidelines

02238348 RESCRIPTOR - delavirdine mesylate J05AG Oral Solid Does Not 100 MG/TAB /Tablet Trigger

Patented Drug Products for Human Use Reported to the PMPRB in 2016 141

PMPRB Annual Report 2016

01902652 RETROVIR - zidovudine J05AF Oral Liquid Expired Within 10 MG/MILLILITER /Solution Guidelines

01902660 RETROVIR - zidovudine J05AF Oral Solid Expired Does Not 100 MG/CAPSULE /Capsule Trigger

01902644 RETROVIR - zidovudine J05AF Parenteral Expired Does Not 10 MG/MILLILITER /Solution Trigger

02261553 TELZIR - fosamprenavir calcium J05AE Oral Liquid Does Not 50 MG/MILLILITER /Suspension Trigger

02261545 TELZIR - fosamprenavir calcium J05AE Oral Solid Within 700 MG/TAB /Tablet Guidelines

02414945 TIVICAY - dolutegravir J05AX Oral Solid Introduced Within 50 MG/TAB /Tablet Guidelines

02430932 TRIUMEQ dolutegravir/ abacavir/ J05AR Oral Solid Within 50/600/300 lamivudine /Tablet Guidelines

02244757 TRIZIVIR abacavir sulfate/ J05AF Oral Solid Within 150/300/300 lamivudine/ zidovudine /Tablet Guidelines

02240358 ZIAGEN - abacavir sulfate J05AF Oral Liquid Within 20 MG/MILLILITER /Solution Guidelines

02240357 ZIAGEN - abacavir sulfate J05AF Oral Solid Within 300 MG/TAB /Tablet Guidelines

Patented Drug Products for Human Use Reported to the PMPRB in 2016 142