PMPRB Annual Report 2017 PMPRB PATENTED MEDICINES for HUMAN USE REPORTED to the PMPRB in 2017∗ JANUARY 1

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PMPRB Annual Report 2017 PMPRB PATENTED MEDICINES FOR HUMAN USE REPORTED TO THE PMPRB IN 2017∗ JANUARY 1 – DECEMBER 31, 2017

Abbvie

DIN Brand Name Medicinal Ingredient 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 VCU 40 MG/SYRINGE /Solution

02312301 KALETRA lopinavir/ritonavir J05AE Oral Solid Within 100/25 - 125 MG/TAB /Tablet Guidelines

02285533 KALETRA lopinavir/ritonavir J05AE Oral Solid Within 200/50 - 250 MG/TAB /Tablet Guidelines

02243644 KALETRA 80/20 - lopinavir/ritonavir J05AE Oral Liquid Within 100 MG/MILLILITER /Solution Guidelines

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

∗ Does not include medicines introduced or patented in December 2016. Patented Medicines for Human Use Reported to the PMPRB in 2017 1

PMPRB Annual Report 2017

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

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

02467550 MAVIRET 100/40 - glecaprevir/pibrentasvir J05AP Oral Solid Introduced Under 140 MG/TAB /Tablet Review

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

02438372 SYNAGIS - palivizumab J06BB Parenteral Within 50 MG/VIAL /Solution Guidelines

02438364 SYNAGIS - palivizumab J06BB Parenteral Within 100 MG/VIAL /Solution Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 2

PMPRB Annual Report 2017

02458039 VENCLEXTA - venetoclax L01XX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02458047 VENCLEXTA - venetoclax L01XX Oral Solid Within 50 MG/TAB /Tablet Guidelines

02458055 VENCLEXTA - venetoclax L01XX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02458063 VENCLEXTA venetoclax L01XX Oral Solid Within 10/50/100 /Tablet Guidelines

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

Acerus Pharmaceuticals SRL

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02450550 NATESTO - testosterone G03BA Nasal Subj. 5.5 MG/ACTUATION /Other Investigation

Actelion Pharmaceuticals Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02397447 CARIPUL - epoprostenol sodium B01AC Parenteral Does Not 0.5 MG/VIAL /Powder for Trigger solution

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

02415690 OPSUMIT - macitentan C02KX Oral Solid Within 10 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 3

PMPRB Annual Report 2017

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

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

02244981 TRACLEER - bosentan monohydrate C02KX Oral Solid Subj. 62.5 MG/TAB /Tablet Investigation

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

02451158 UPTRAVI - selexipag B01AC Oral Solid Within 200 MCG/TAB /Tablet Guidelines

02451166 UPTRAVI - selexipag B01AC Oral Solid Within 400 MCG/TAB /Tablet Guidelines

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

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

02451190 UPTRAVI - selexipag B01AC Oral Solid Within 1000 MCG/TAB /Tablet Guidelines

02451204 UPTRAVI - selexipag B01AC Oral Solid Subj. 1200 MCG/TAB /Tablet Investigation

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

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

02250519 ZAVESCA - miglustat A16AX Oral Solid Subj. 100 MG/CAPSULE /Capsule Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 4

PMPRB Annual Report 2017

Alcon Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

Alexion Pharmaceuticals Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02444615 STRENSIQ - asfotase alfa A16AB Parenteral Subj. 18 MG/VIAL /Solution Investigation

02444658 STRENSIQ - asfotase alfa A16AB Parenteral Subj. 80 MG/VIAL /Solution Investigation

02444623 STRENSIQ - asfotase alfa A16AB Parenteral Subj. 28 MG/VIAL /Solution Investigation

ALK- Abelló A S

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02418304 GRASTEK - standardized allergen extract, V01AA Dental - Within 2800 UNIT/TAB timothy grass (phleum Sublingual Guidelines pratense) Buccal /Sublingual tablets

Patented Medicines for Human Use Reported to the PMPRB in 2017 5

PMPRB Annual Report 2017

02423723 RAGWITEK - standardized allergen extract, V01AA Dental - Within 12 UNIT/TAB short ragweed (ambrosia Sublingual Guidelines artemisifolia) Buccal /Sublingual tablets

Allergan Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02242518 ACTONEL - risedronate M05BA Oral Solid Does Not 5 MG/TAB /Tablet Trigger

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 Does Not 150 MG/TAB /Tablet Trigger

02370417 ACTONEL DR - risedronate M05BA Oral Solid Within 35 MG/TAB /Modified Guidelines 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

Patented Medicines for Human Use Reported to the PMPRB in 2017 6

PMPRB Annual Report 2017

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

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

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

01997580 ASACOL 400 - mesalamine A07EC Oral Solid Does Not 400 MG/TAB /Modified Trigger release tablets

02267217 ASACOL 800 - mesalamine A07EC Oral Solid Within 800 MG/TAB /Modified Guidelines release tablets

02443910 BELKYRA - deoxycholic acid D11AX Parenteral 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

Patented Medicines for Human Use Reported to the PMPRB in 2017 7

PMPRB Annual Report 2017

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

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

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

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

02408163 FIBRISTAL - ulipristal acetate G03XB Oral Solid Subj. 5 MG/TAB /Tablet Investigation

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/Gel Subj. 36 MG/POUCH Investigation

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 8

PMPRB Annual Report 2017

02361663 RAPAFLO - silodosin G04CA Oral Solid Subj. 4 MG/CAPSULE /Capsule Investigation

02361671 RAPAFLO - silodosin G04CA Oral Solid Subj. 8 MG/CAPSULE /Capsule Investigation

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 400 MG/VIAL /Powder for Trigger solution

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

02240000 TRELSTAR - triptorelin pamoate L02AE Parenteral Subj. 3.75 MG/VIAL /Powder for Investigation solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 9

PMPRB Annual Report 2017

02243856 TRELSTAR - triptorelin pamoate L02AE Parenteral Subj. 11.25 MG/VIAL /Powder for Investigation solution

02412322 TRELSTAR - triptorelin pamoate L02AE Parenteral Subj. 22.5 MG/VIAL /Powder for Investigation solution

02460890 VIBERZI - 75 MG/TAB eluxadoline A07DA Oral Solid Introduced Within /Tablet Guidelines

02460904 VIBERZI - eluxadoline A07DA Oral Solid Introduced Within 100 MG/TAB /Tablet Guidelines

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

Altius Healthcare Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

Amgen Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 10

PMPRB Annual Report 2017

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

02459930 KYPROLIS - carfilzomib L01XX Parenteral Introduced Does Not 10 MG/VIAL /Powder for Trigger solution

02459949 KYPROLIS - carfilzomib L01XX Parenteral Introduced Does Not 30 MG/VIAL /Powder for Trigger solution

02451034 KYPROLIS - carfilzomib L01XX Parenteral 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 Within 0.6 MG/MILLILITER /Solution Guidelines

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

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

02322854 NPLATE - romiplostim B02BX Parenteral Under Review 250 MCG/VIAL /Powder for solution

02322862 NPLATE - romiplostim B02BX Parenteral Under Review 500 MCG/VIAL /Powder for solution

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

02459779 REPATHA - evolocumab C10AX Parenteral Introduced Subj. 120 MG/MILLILITER /Solution Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 11

PMPRB Annual Report 2017

02446057 REPATHA - evolocumab C10AX Parenteral VCU 140 MG/SYRINGE /Solution

02257130 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Does Not 30 MG/TAB /Tablet Trigger

02257149 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Does Not 60 MG/TAB /Tablet Trigger

02257157 SENSIPAR - cinacalcet hydrochloride H05BX Oral Solid Does Not 90 MG/TAB /Tablet Trigger

02308509 VECTIBIX - panitumumab L01XC Parenteral Introduced VCU 20 MG/MILLILITER /Solution

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

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

Aspen Pharmacare Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02087286 ALKERAN - melphalan hydrochloride L01AA Parenteral Expired Subj. 50 MG/VIAL /Powder for Investigation solution

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

02258056 ARIXTRA - fondaparinux sodium B01AX Parenteral Within 7.5 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 12

PMPRB Annual Report 2017

Astellas Pharma Canada Inc.

DIN Brand Name Medicinal Ingredient 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 Within 50 MG/VIAL /Powder for Guidelines 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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 13

PMPRB Annual Report 2017

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

Astrazeneca Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02224135 ARIMIDEX - anastrozole L02BG Oral Solid Does Not 1 MG/TAB /Tablet Trigger

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

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

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

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

02361809 BYETTA - exenatide A10BX Parenteral Within 5 MCG/DOSE /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 14

PMPRB Annual Report 2017

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

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

02359456 DAXAS - roflumilast R03DX Oral Solid Within 500 MCG/TAB /Tablet Guidelines

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

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

02426544 FLUMIST influenza vaccine (live, J07BB Nasal /Spray Subj. QUADRIVALENT - attenuated) Investigation 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 - 250 MG/TAB gefitinib L01XX Oral Solid Within /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 15

PMPRB Annual Report 2017

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

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

00846503 LOSEC - omeprazole A02BC Oral Solid Does Not 20 MG/CAPSULE /Capsule Trigger

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

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

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

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 16

PMPRB Annual Report 2017

02303671 OMNARIS - ciclesonide R03BA Nasal Within 50 MCG/DOSE /Metered Guidelines dose preparations

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

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

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

02237224 OXEZE TURBUHALER - formoterol fumarate R03AC Pulmonary Does Not 0.012 MG/DOSE /Powder Trigger

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 17

PMPRB Annual Report 2017

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

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

02236952 SEROQUEL - quetiapine fumarate N05AH Oral Solid Expired Within 100 MG/TAB /Tablet Guidelines

02236953 SEROQUEL - quetiapine fumarate N05AH Oral Solid Expired Within 200 MG/TAB /Tablet Guidelines

02244107 SEROQUEL - quetiapine fumarate N05AH Oral Solid Expired Within 300 MG/TAB /Tablet Guidelines

02300184 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Expired Within 50 MG/TAB /Modified Guidelines release tablets

02321513 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Expired Within 150 MG/TAB /Modified Guidelines release tablets

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

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

02300214 SEROQUEL XR - quetiapine fumarate N05AH Oral Solid Expired Within 400 MG/TAB /Modified Guidelines release tablets

Patented Medicines for Human Use Reported to the PMPRB in 2017 18

PMPRB Annual Report 2017

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

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

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

02456222 TAGRISSO - osimertinib L01XE Oral Solid 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 Within hydrochloride /Tablet Guidelines

02449935 XIGDUO 5/850 dapagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 19

PMPRB Annual Report 2017

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

Baxalta Canada Corporation

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

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

02365944 ADVATE 250 (WITH antihemophilic factor B02BD Parenteral Within 2ML DILUENT) (recombinant), /Powder for Guidelines plasma/albumin free method solution (rahf-pfm)

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

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

02461900 ONCASPAR - l-asparaginase L01XX Parenteral Within 750 UNIT/MILLILITER /Solution Guidelines

02431939 RIXUBIS - recombinant coagulation B02BD Parenteral Introduced Under Review 500 UNIT/VIAL factor ix (rfix), nonacog /Powder for gamma solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 20

PMPRB Annual Report 2017

02431947 RIXUBIS - recombinant coagulation B02BD Parenteral Introduced Under Review 1000 UNIT/VIAL factor ix (rfix), nonacog /Powder for gamma solution

02431955 RIXUBIS - recombinant coagulation B02BD Parenteral Introduced Under Review 2000 UNIT/VIAL factor ix (rfix), nonacog /Powder for gamma solution

Baxter Corporation

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02326167 ARTISS VHSD - fibrin sealant B02BC Topical Expired 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

Bayer Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 21

PMPRB Annual Report 2017

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 Expired Within /Tablet Guidelines

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

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

02247916 CIPRO XL - ciprofloxacin hydrochloride J01MA Oral Solid Does Not 500 MG/TAB /Modified Trigger release tablets

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 /Solution Guidelines MG/MILLILITER

Patented Medicines for Human Use Reported to the PMPRB in 2017 22

PMPRB Annual Report 2017

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

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

02408295 JAYDESS - levonorgestrel G02BA Vaginal Within 13.5 MG/UNIT /Insert Guidelines

02451441 KOVALTRY antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02451468 KOVALTRY antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02451476 KOVALTRY antihemophilic factor B02BD Parenteral Within (recombinant) /Powder for Guidelines solution

02451484 KOVALTRY antihemophilic factor B02BD Parenteral Subj. (recombinant) /Powder for Investigation solution

02451492 KOVALTRY antihemophilic factor B02BD Parenteral Subj. (recombinant) /Powder for Investigation 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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 23

PMPRB Annual Report 2017

02266121 SATIVEX 27/25 - delta-9-tetrahydrocannabinol/ N02BG Dental - Within 52 MG/MILLILITER cannabidiol Sublingual Guidelines Buccal /Sprays - Buccal

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

02403390 STIVARGA - regorafenib L01XE Oral Solid Within 40 MG/TAB /Tablet Guidelines

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

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

02261723 YASMIN 21 3/0.03 drospirenone/ethinyl estradiol G03AA Oral Solid Subj. /Tablet Investigation

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 24

PMPRB Annual Report 2017

BGP Pharma ULC

DIN Brand Name Medicinal Ingredient 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 - 250 MG/TAB clarithromycin J01FA Oral Solid Does Not /Tablet Trigger

02126710 BIAXIN - 500 MG/TAB clarithromycin J01FA Oral Solid Does Not /Tablet Trigger

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

02200104 CREON pancreatin A09AA Oral Solid Subj. MINIMICROSPHERES /Capsule Investigation 10 - 10000 UNIT/CAPSULE

Patented Medicines for Human Use Reported to the PMPRB in 2017 25

PMPRB Annual Report 2017

01985205 CREON pancreatin A09AA Oral Solid Subj. MINIMICROSPHERES /Capsule Investigation 25 - 25000 UNIT/CAPSULE

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

02445158 CREON pancreatin A09AA Oral Solid Does Not MINIMICROSPHERES /Granules Trigger MICRO - 5000 UNIT/DOSE

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

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

02432889 DYMISTA 137/50 azelastine R01AD Nasal Within hydrochloride/fluticasone /Solution Guidelines propionate

02269562 INFLUVAC - influenza vaccine, surface J07BB Parenteral / Within 15 MCG/SYRINGE antigen, inactivated Suspensions Guidelines or Emulsions

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 26

PMPRB Annual Report 2017

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

02165503 PREVACID - lansoprazole A02BC Oral Solid Within 15 MG/CAPSULE /Modified Guidelines 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 Subj. 30 MG/TAB /Tablet Investigation

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 27

PMPRB Annual Report 2017

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

Biogen Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02269201 AVONEX PS - interferon beta-1a L03AB Parenteral Within 30 MCG/SYRINGE /Solution Guidelines

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

02444402 PLEGRIDY peginterferon beta-1a/ L03AB Parenteral Does Not peginterferon alfa-2a /Solution Trigger

02444399 PLEGRIDY - peginterferon beta-1a L03AB Parenteral Does Not 125 MCG/SYRINGE /Solution Trigger

02404508 TECFIDERA - dimethyl fumarate N07XX Oral Solid Within 120 MG/CAPSULE /Capsule Guidelines

02420201 TECFIDERA - dimethyl fumarate N07XX Oral Solid Within 240 MG/CAPSULE /Capsule Guidelines

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

02459620 ZINBRYTA - daclizumab beta L04AC Parenteral Introduced Within 150 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 28

PMPRB Annual Report 2017

Biomarin Pharmaceutical Canada Inc.

DIN Brand Name Medicinal Ingredient 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 Medicinal Ingredient ATC Dosage Comments Status

02436639 CYSVIEW - hexaminolevulinate V04CX Parenteral VCU 100 MG/VIAL hydrochloride /Powder for solution

Bioverativ Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02422913 ALPROLIX - coagulation factor ix B02BD Parenteral Does Not 500 IU/VIAL (recombinant), fc fusion /Powder for Trigger protein solution

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 29

PMPRB Annual Report 2017

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

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

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

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

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

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

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

Boehringer Ingelheim (Canada) Ltd.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02419106 COMBIVENT ipratropium bromide R03AL Pulmonary Subj. RESPIMAT 20/100 monohydrate/salbutamol /Solution Investigation sulfate

Patented Medicines for Human Use Reported to the PMPRB in 2017 30

PMPRB Annual Report 2017

02415666 GIOTRIF - afatinib L01XE Oral Solid Subj. 20 MG/TAB /Tablet Investigation

02415674 GIOTRIF - afatinib L01XE Oral Solid Subj. 30 MG/TAB /Tablet Investigation

02415682 GIOTRIF - afatinib L01XE Oral Solid Subj. 40 MG/TAB /Tablet Investigation

02459752 GLYXAMBI 10/5 empagliflozin/linagliptin A10BD Oral Solid Introduced Within /Tablet Guidelines

02459760 GLYXAMBI 25/5 empagliflozin/linagliptin A10BD Oral Solid Introduced Within /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 Within 10 MG/TAB /Tablet Guidelines

02443945 JARDIANCE - empagliflozin A10BX Oral Solid Within 25 MG/TAB /Tablet Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 31

PMPRB Annual Report 2017

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

02318709 MICARDIS PLUS telmisartan/hydrochlorothiazide C09DA Oral Solid Within 80/25 /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 Within 100 MG/CAPSULE /Capsule Guidelines

02443074 OFEV - nintedanib L01XE Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 32

PMPRB Annual Report 2017

02435381 SPIRIVA RESPIMAT tiotropium bromide R03BB Pulmonary Within - 2.5 MCG/ monohydrate /Solution Guidelines ACTUATION

02456621 SYNJARDY empagliflozin/metformin A10BD Oral Solid Within 12.5/1000 hydrochloride /Tablet Guidelines

02456605 SYNJARDY empagliflozin/metformin A10BD Oral Solid Within 12.5/500 hydrochloride /Tablet Guidelines

02456613 SYNJARDY empagliflozin/metformin A10BD Oral Solid Does Not 12.5/850 hydrochloride /Tablet Trigger

02456591 SYNJARDY 5/1000 empagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02456575 SYNJARDY 5/500 empagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02456583 SYNJARDY 5/850 empagliflozin/metformin A10BD Oral Solid Does Not hydrochloride /Tablet Trigger

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 33

PMPRB Annual Report 2017

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

Bracco Diagnostics Canada Inc.

DIN Brand Name Medicinal Ingredient 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 Medicinal Ingredient ATC Dosage Comments Status

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

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

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 34

PMPRB Annual Report 2017

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

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

02446731 EVOTAZ 300/150 atazanavir sulphate/cobicistat J05AR Oral Solid Within /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 Within 150 MG/CAPSULE /Capsule Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 35

PMPRB Annual Report 2017

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

02293145 SPRYCEL - dasatinib L01XE Oral Solid Within 70 MG/TAB /Tablet Guidelines

02360810 SPRYCEL - dasatinib L01XE Oral Solid Within 80 MG/TAB /Tablet Guidelines

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

02239886 SUSTIVA - efavirenz J05AG Oral Solid Within 50 MG/CAPSULE /Capsule Guidelines

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

BTG International Ltd.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02444267 VARITHENA - polidoconcol C05BB Parenteral Introduced Within 1.3 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 36

PMPRB Annual Report 2017

Celgene Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02281066 ABRAXANE - nanoparticle albumin-bound L01CD Parenteral Within 100 MG/VIAL paclitaxel /Suspensions Guidelines 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

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

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

02459418 REVLIMID - lenalidomide L04AX Oral Solid Introduced Within 2.5 MG/CAPSULE /Capsule Guidelines

02304899 REVLIMID - lenalidomide L04AX Oral Solid Within 5 MG/CAPSULE /Capsule Guidelines

02304902 REVLIMID - lenalidomide L04AX Oral Solid Within 10 MG/CAPSULE /Capsule Guidelines

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 37

PMPRB Annual Report 2017

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

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

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

Cheplapharm Arzneimittel GMBH

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02240325 XENICAL - orlistat A08AB Oral Solid Does Not 120 MG/CAPSULE /Capsule Trigger

Cipher Pharmaceuticals Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

CSL Behring Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02418746 CORIFACT 1250 - factor xiii concentrate, B02BD Parenteral Subj. 1250 IU/MILLILITER human /Powder for Investigation solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 38

PMPRB Annual Report 2017

02418738 CORIFACT 250 - factor xiii concentrate, human B02BD Parenteral Subj. 250 IU/MILLILITER /Powder for Investigation solution

02370352 HIZENTRA - subcutaneous immune globulin J06BA Parenteral Within 200 MG/MILLILITER (human) /Solution Guidelines

02304619 PRIVIGEN - immune globulin intravenous J06BA Parenteral Within 100 MG/MILLILITER (human) /Solution Guidelines

Duchesnay Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02460262 MICTORYL - propiverine hcl G04BD Oral Solid Introduced Within 30 MG/CAPSULE /Modified Guidelines release capsules

02460270 MICTORYL - propiverine hcl G04BD Oral Solid Introduced Within 45 MG/CAPSULE /Modified Guidelines release capsules

02460289 MICTORYL PEDIATRIC propiverine hcl G04BD Oral Solid Introduced Does Not - 5 MG/TAB /Tablet Trigger

02451573 PREGVIT multivitamin-minerals B03AE Oral Solid Within /Tablet Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 39

PMPRB Annual Report 2017

02451581 PREGVIT FOLIC 5 multivitamins-minerals B03AE Oral Solid Within /Tablet Guidelines

02276194 PREGVIT FOLIC 5 multivitamins-minerals B03AE Oral Solid Within /Tablet Guidelines

Eisai Limited

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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 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

Patented Medicines for Human Use Reported to the PMPRB in 2017 40

PMPRB Annual Report 2017

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

02450321 LENVIMA - lenvatinib mesylate L01XE Oral Solid Within 10 MG/DAY /Capsule Guidelines

02450305 LENVIMA 10/ lenvatinib mesylate L01XE Oral Solid Within 10 - 20 MG/DAY /Capsule Guidelines

02450291 LENVIMA 10/10/ lenvatinib mesylate L01XE Oral Solid Within 4 - 24 MG/DAY /Capsule Guidelines

02450313 LENVIMA 10/ lenvatinib mesylate L01XE Oral Solid Within 4 - 14 MG/DAY /Capsule Guidelines

Eli Lilly Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02338327 ADCIRCA - tadalafil C02KX Oral Solid VCU 20 MG/TAB /Tablet

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 G03BA Topical Within 30 MG/DOSE /Liquid Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 41

PMPRB Annual Report 2017

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

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

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

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

02443805 CYRAMZA - ramucirumab L01XC Parenteral VCU 10 MG/MILLILITER /Solution

02349124 EFFIENT - 10 MG/TAB prasugrel hydrochloride B01AC Oral Solid VCU /Tablet

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 42

PMPRB Annual Report 2017

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

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

02403439 HUMALOG MIX 50 insulin lispro A10AB Parenteral Within KWIKPEN - /Solution Guidelines 100 UNIT/MILLILITER

02240294 HUMALOG MIX 25/75 insulin (lispro/lispro A10AB Parenteral Within protamine) /Solution Guidelines

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 43

PMPRB Annual Report 2017

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 Does Not 80 MG/MILLILITER /Solution Trigger

02455110 TALTZ - ixekizumab L04AC Parenteral Does Not 80 MG/MILLILITER /Solution Trigger

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

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

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

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

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

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

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 44

PMPRB Annual Report 2017

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

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

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

02243089 ZYPREXA ZYDIS - olanzapine N05AH Oral Solid Expired Does Not 20 MG/TAB /Tablet Trigger

EMD Serono Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02248157 GONAL-F - follitropin alpha G03GA Parenteral Subj. 75 UNIT/VIAL /Powder Investigation for solution

02248156 GONAL-F - follitropin alpha G03GA Parenteral Does Not 75 UNIT/VIAL /Powder Trigger for solution

02248154 GONAL-F - follitropin alpha G03GA Parenteral Does Not 75 UNIT/VIAL /Powder Trigger for solution

02270404 GONAL-F PEN - follitropin alpha G03GA Parenteral Does Not 300 UNIT/PEN /Solution Trigger

02270390 GONAL-F PEN - follitropin alpha G03GA Parenteral Subj. 450 UNIT/PEN /Solution Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 45

PMPRB Annual Report 2017

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

02269066 LUVERIS - lutropin alpha G03GA Parenteral Within 75 UNIT/VIAL /Powder Guidelines for solution

02470179 MAVENCLAD - cladribine L01BB Oral Solid Introduced Under 10 MG/TAB /Tablet Review

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

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 Medicinal Ingredient ATC Dosage Comments Status

02455889 CORTIMENT - budesonide A07EA Oral Solid Within 9 MG/TAB /Tablet Guidelines

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 46

PMPRB Annual Report 2017

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 Within 80 MG/VIAL /Powder for Guidelines solution

02337037 FIRMAGON - degarelix acetate L02BX Parenteral Within 120 MG/VIAL /Powder for Guidelines solution

02397927 NOCDURNA - desmopressin acetate H01BA Dental - Subj. 25 MCG/TAB Sublingual Investigation Buccal /Sublingual tablets

02431076 NOCDURNA - desmopressin acetate H01BA Dental - Subj. 50 MCG/TAB Sublingual Investigation Buccal /Sublingual tablets

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

02099683 PENTASA - mesalamine A07EC Oral Solid Within 500 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 47

PMPRB Annual Report 2017

Galderma Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02375885 APPRILON - doxycycline monohydrate J01AA Oral Solid Within 40 MG/CAPSULE /Modified Guidelines release capsules

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

02421208 ONRELTEA - brimonidine gel S01EA Topical /Gel VCU 5 MG/GRAM

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

02365871 TACTUPUMP 1/25 - adapalene/benzoyl peroxide D10AD Topical /Gel Does Not 26 MG/GRAM Trigger

02446235 TACTUPUMP adapalene/benzoyl peroxide D10AD Topical /Gel Within FORTE - Guidelines 70 G/PUMP

Gilead Sciences Inc.

DIN Brand Name Medicinal Ingredient 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 Within 75 MG/VIAL /Powder Guidelines

02374129 COMPLERA emtricitabine/tenofovir J05AR Oral Solid Within 200/300/25 disoproxil fumarate/rilpivirine /Tablet Guidelines hydrochloride

Patented Medicines for Human Use Reported to the PMPRB in 2017 48

PMPRB Annual Report 2017

02454416 DESCOVY 200/10 emtricitabine/tenofovir J05AR Oral Solid Within alafenamide /Tablet Guidelines

02454424 DESCOVY 200/25 emtricitabine/tenofovir J05AR Oral Solid Within alafenamide /Tablet Guidelines

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

02449498 GENVOYA elvitegravir/cobicistat/ J05AR Oral Solid VCU 200/150/150/10 emtricitabine/tenofovir /Tablet alafenamide

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

02461463 ODEFSEY 200/25/25 emtricitabine/rilpivirine/ J05AR Oral Solid Introduced Within tenofovir alafenamide /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 VCU disoproxil fumarate /Tablet

02464241 VEMLIDY - tenofovir alafenamide J05AF Oral Solid Introduced Under Review 25 MG/TAB /Tablet

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 49

PMPRB Annual Report 2017

02467542 VOSEVI 400/100/100 sofosbuvir/velpatasvir/ J05AX Oral Solid Introduced Under Review voxilaprevir /Tablet

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

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

Glaxosmithkline Inc.

DIN Brand Name Medicinal Ingredient 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 trifenatate

Patented Medicines for Human Use Reported to the PMPRB in 2017 50

PMPRB Annual Report 2017

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

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

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

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 - 8 MG/TAB rosiglitazone maleate A10BG Oral Solid Does Not /Tablet Trigger

02370050 BENLYSTA - belimumab L04AA Parenteral Subj. 120 MG/VIAL /Powder for Investigation solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 51

PMPRB Annual Report 2017

02370069 BENLYSTA - belimumab L04AA Parenteral Subj. 400 MG/VIAL /Powder for Investigation 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 or Emulsions

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

02408872 BREO ELLIPTA 100/25 fluticasone furoate/vilanterol R03AK Pulmonary Within /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 - 250 MG/TAB cefuroxime axetil J01DC Oral Solid VCU /Tablet

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

02342227 CERVARIX human papillomavirus J07BM Parenteral Subj. vaccine (recombinant) /Suspensions Investigation or Emulsions

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 52

PMPRB Annual Report 2017

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 Within /Suspension Guidelines

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

02238829 CLAVULIN 875/125 amoxicillin: clavulanic acid J01CR Oral Solid Subj. /Tablet Investigation

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

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

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

00068594 COACTIFED SYRUP - triprolidine R05DA Oral Liquid VCU 10 MG/DOSE hydrochlloride/pseudoephed /Solution rine hydrochloride/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

Patented Medicines for Human Use Reported to the PMPRB in 2017 53

PMPRB Annual Report 2017

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

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

01919431 ENGERIX-B hepatitis b vaccine J07BC Parenteral Subj. (recombinant) /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

Patented Medicines for Human Use Reported to the PMPRB in 2017 54

PMPRB Annual Report 2017

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

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

02187078 HAVRIX 1440 - hepatitis a vaccine, J07BC Parenteral Within 1440 UNIT/ inactivated /Suspensions Guidelines MILLILITER or Emulsions

02231056 HAVRIX 720 JUNIOR - hepatitis a vaccine, J07BC Parenteral Within 1440 UNIT/ inactivated /Suspensions Guidelines 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 vaccine /Powder for (tetanus protein – conjugate) solution

02230418 IMITREX - sumatriptan hemisulphate N02CC Nasal /Spray Within 5 MG/DOSE Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 55

PMPRB Annual Report 2017

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

02253852 INFANRIX HEXA combined diphtheria and J07CA Parenteral Subj. tetanus toxoids, acellular /Suspensions Investigation pertussis, hepatitis b or Emulsions (recombinant), inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type B vaccine

02257122 INFANRIX IPV/HIB combined diphtheria, J07CA Parenteral Within tetanus, acellular pertussis, /Suspensions Guidelines inactivated poliomyelitis, or Emulsions Haemophilus influenzae type B vaccine

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

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

02440709 MENJUGATE LIQUID meningococcal group c J07AH Parenteral Within conjugate vaccine /Suspensions Guidelines or Emulsions

02243820 MENJUGATE meningococcal group c J07AH Parenteral Does Not POWDER conjugate vaccine /Powder for Trigger solution

02347393 MENVEO - meningococcal J07AH Parenteral Subj. 72 MCG/DOSE oligosaccharide CRM /Powder for Investigation conjugate vaccine solution

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 56

PMPRB Annual Report 2017

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

00804541 PREVEX B - betamethasone valerate D07AC Topical VCU 1 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

02267667 RABAVERT rabies vaccine inactivated J07BG Parenteral Within /Powder for Guidelines solution

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

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

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

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

02300591 ROTARIX human rotavirus, live, J07BH Oral Liquid Within attenuated, oral vaccine /Powder for Guidelines suspension

02214261 SEREVENT DISKHALER salmeterol xinafoate R03AC Pulmonary Subj. - 0.05 MG/DOSE /Powder Investigation

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 57

PMPRB Annual Report 2017

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

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 Within 1 MG/GRAM /Cream Guidelines

02230578 TWINRIX 720/20 combined hepatitis a J07BC Parenteral Within (inactivated) and hepatitis b /Suspensions Guidelines (recombinant) vaccine or Emulsions

02237548 TWINRIX JUNIOR combined hepatitis a J07BC Parenteral Subj. 360/10 (inactivated) and hepatitis b /Suspensions Investigation (recombinant) vaccine 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 Subj. 0.2 MG/DOSE /Powder Investigation

02241497 VENTOLIN HFA - salbutamol sulfate R03AC Pulmonary Within 0.1 MG/DOSE /Metered Guidelines dose preparations

Patented Medicines for Human Use Reported to the PMPRB in 2017 58

PMPRB Annual Report 2017

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 sulfate R03AC Pulmonary VCU 5 MG/DOSE /Solution

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

02307065 VOLIBRIS - 5 MG/TAB ambrisentan C02KX Oral Solid Within /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 Medicinal Ingredient ATC Dosage Comments Status

02247724 GAMUNEX - immune globulin intravenous J06BA Parenteral Subj. 100 MG/MILLILITER (human) /Solution Investigation

02189119 PLASBUMIN-25 - albumin (human) B05AA Parenteral Within 250 MG/MILLILITER /Solution Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 59

PMPRB Annual Report 2017

02204606 PROLASTIN - alpha1-proteinase inhibitor B02AB Parenteral Within 25 MG/MILLILITER (human) /Powder Guidelines for solution

Hoffmann-La Roche Limited

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02350092 ACTEMRA - tocilizumab L04AC Parenteral Does Not 20 MG/MILLILITER /Solution Trigger

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

02350114 ACTEMRA - tocilizumab L04AC Parenteral Subj. 20 MG/MILLILITER /Solution Investigation

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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 60

PMPRB Annual Report 2017

02393751 ESBRIET - pirfenidone L04AX Oral Solid Subj. 267 MG/CAPSULE /Capsule Investigation

02464489 ESBRIET - pirfenidone L04AX Oral Solid Introduced Within 267 MG/TAB /Tablet Guidelines

02464500 ESBRIET - pirfenidone L04AX Oral Solid Introduced Within 801 MG/TAB /Tablet Guidelines

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

02434806 GAZYVA - obinutuzumab L01XC Parenteral Within 25 MG/MILLILITER /Solution Guidelines

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 - /Solution Guidelines 5 MG/MILLILITER

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 61

PMPRB Annual Report 2017

02249002 NUTROPIN AQ PEN - somatropin H01AC Parenteral Within 5 MG/MILLILITER /Solution Guidelines

02467224 OCREVUS - ocrelizumab L04AA Parenteral Introduced Under Review 30 MG/MILLILITER /Solution

02248077 PEGASYS - 180 peginterferon alfa-2a L03AB Parenteral Within MCG/SYRINGE /Solution Guidelines

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

02457350 RITUXAN SC - rituximab L01XC Parenteral 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 Subj. - 30 MG/CAPSULE /Capsule Investigation

02304856 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Solid Subj. - 45 MG/CAPSULE /Capsule Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 62

PMPRB Annual Report 2017

02241472 TAMIFLU (SEASONAL) oseltamivir phosphate J05AH Oral Solid Subj. - 75 MG/CAPSULE /Capsule Investigation

02269007 TARCEVA - erlotinib hydrochloride L01XX Oral Solid Does Not 25 MG/TAB /Tablet Trigger

02269015 TARCEVA - erlotinib hydrochloride L01XX Oral Solid Does Not 100 MG/TAB /Tablet Trigger

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

02462990 TECENTRIQ - atezolizumab L01XC Parenteral Introduced Within 60 MG/MILLILITER /Solution Guidelines

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

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

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

02238453 XELODA - capecitabine L01BC Oral Solid Within 150 MG/TAB /Tablet Guidelines

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

02380242 ZELBORAF - vemurafenib L01XE Oral Solid Does Not 240 MG/TAB /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 63

PMPRB Annual Report 2017

Horizon Pharma PLC

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02464705 PROCYSBI - cysteamine bitartrate A16AA Oral Solid Introduced Subj. 25 MG/CAPSULE /Modified Investigation release capsules

02464713 PROCYSBI - cysteamine bitartrate A16AA Oral Solid Introduced Subj. 75 MG/CAPSULE /Modified Investigation release capsules

02442302 QUINSAIR - levofloxacin J01MA Pulmonary Introduced Subj. 100 MG/MILLILITER /Solution Investigation

Intercept Pharmaceuticals Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02463121 OCALIVA - 5 MG/TAB obeticholic acid A05AA Oral Solid Introduced Within /Tablet Guidelines

02463148 OCALIVA - obeticholic acid A05AA Oral Solid Introduced Within 10 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 64

PMPRB Annual Report 2017

Ipsen Biopharmaceuticals Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02387735 DYSPORT AESTHETIC abobotulinumtoxina M03AX Parenteral Within - 300 UNIT/VIAL /Powder for Guidelines solution

02460203 DYSPORT abobotulinumtoxina M03AX Parenteral Introduced Within THERAPEUTIC /Powder for Guidelines - 300 UNIT/VIAL solution

02456117 DYSPORT abobotulinumtoxina M03AX Parenteral Introduced Within THERAPEUTIC /Powder for Guidelines - 500 UNIT/VIAL 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

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

Janssen Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02238389 CAELYX - doxorubicin hydrochloride L01DB Parenteral Does Not 2 MG/MILLILITER /Solution Trigger

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 65

PMPRB Annual Report 2017

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

02247733 CONCERTA - methylphenidate N06BA Oral Solid Expired Within 36 MG/TAB hydrochloride /Modified Guidelines release tablets

02247734 CONCERTA - methylphenidate N06BA Oral Solid Expired Within 54 MG/TAB hydrochloride /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

Patented Medicines for Human Use Reported to the PMPRB in 2017 66

PMPRB Annual Report 2017

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

02240722 EPREX - epoetin alfa B03XA Parenteral Within 40000 UNIT/ /Solution Guidelines MILLILITER

02416441 GALEXOS - simeprevir J05AE Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

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 - 3 MG/TAB paliperidone N05AX Oral Solid Within /Modified Guidelines release tablets

02300281 INVEGA - 6 MG/TAB paliperidone N05AX Oral Solid Does Not /Modified Trigger release tablets

02300303 INVEGA - 9 MG/TAB paliperidone N05AX Oral Solid Does Not /Modified Trigger release tablets

Patented Medicines for Human Use Reported to the PMPRB in 2017 67

PMPRB Annual Report 2017

02354217 INVEGA SUSTENNA - paliperidone palmitate N05AX Parenteral Within 50 MG/SYRINGE /Modified Guidelines release injections

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 Does Not 175 MG/SYRINGE /Suspension Trigger (extended release)

02455986 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral Within 263 MG/SYRINGE /Suspension Guidelines (extended release)

02455994 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral Within 350 MG/SYRINGE /Suspension Guidelines (extended release)

02456001 INVEGA TRINZA - paliperidone palmitate N05AX Parenteral Within 525 MG/SYRINGE /Suspension Guidelines (extended release)

02455455 INVOKAMET canagliflozin/metformin A10BD Oral Solid Within 150/1000 hydrochloride /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 68

PMPRB Annual Report 2017

02455439 INVOKAMET 150/500 canagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02455447 INVOKAMET 150/850 canagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02455420 INVOKAMET 50/1000 canagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02455404 INVOKAMET 50/500 canagliflozin/metformin A10BD Oral Solid Within hydrochloride /Tablet Guidelines

02455412 INVOKAMET 50/850 canagliflozin/metformin A10BD Oral Solid Does Not hydrochloride /Tablet Trigger

02425483 INVOKANA - canagliflozin A10BX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02425491 INVOKANA - canagliflozin A10BX Oral Solid Within 300 MG/TAB /Tablet Guidelines

02426501 PREZCOBIX 800/150 darunavir/cobicistat J05AR Oral Solid Within /Tablet Guidelines

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 Expired Within 100 MG/VIAL /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 69

PMPRB Annual Report 2017

02266717 REMINYL ER - galantamine hydrobromide N06DA Oral Solid Within 8 MG/CAPSULE /Modified Guidelines release capsules

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

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

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 Does Not 0.25 MG/TAB /Tablet Trigger

02240552 RISPERDAL - risperidone N05AX Oral Solid Does Not 0.5 MG/TAB /Tablet Trigger

02025280 RISPERDAL - risperidone N05AX Oral Solid Does Not 1 MG/TAB /Tablet Trigger

02025299 RISPERDAL - risperidone N05AX Oral Solid Does Not 2 MG/TAB /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 70

PMPRB Annual Report 2017

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

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 Within 2 MG/TAB /Tablet Guidelines

02268086 RISPERDAL M-TAB - risperidone N05AX Oral Solid Within 3 MG/TAB /Tablet Guidelines

02268094 RISPERDAL M-TAB - risperidone N05AX Oral Solid Does Not 4 MG/TAB /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 71

PMPRB Annual Report 2017

02324776 SIMPONI - golimumab L04AB Parenteral Within 50 MG/SYRINGE /Solution Guidelines

02324784 SIMPONI - golimumab L04AB Parenteral Within 50 MG/SYRINGE /Solution Guidelines

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 Within 100 MG/CAPSULE /Capsule Guidelines

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

02459671 STELARA - ustekinumab L04AC Parenteral Introduced Within 130 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

Patented Medicines for Human Use Reported to the PMPRB in 2017 72

PMPRB Annual Report 2017

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

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

02469758 TREMFYA - guselkumab L04AC Parenteral Introduced Under Review 100 MG/MILLILITER /Solution

02349469 ULTRAM - tramadol hydrochloride N02AX Oral Solid Does Not 50 MG/TAB /Tablet Trigger

02262452 VELCADE - bortezomib L01XX Parenteral Within 3.5 MG/VIAL /Powder for Guidelines solution

02351528 YONDELIS - trabectedin L01CX Parenteral Does Not 1 MG/VIAL /Powder for Trigger solution

02371065 ZYTIGA - 250 MG/TAB abiraterone acetate L02BX Oral Solid Within /Tablet Guidelines

02457113 ZYTIGA - 500 MG/TAB abiraterone acetate L02BX Oral Solid Subj. /Tablet Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 73

PMPRB Annual Report 2017

Jazz Pharmaceuticals, PLC

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02465981 DEFITELIO - defibrotide sodium B01AX Parenteral Subj. 200 MG/VIAL /Solution Investigation

Johnson & Johnson Medical Products

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02348497 EVICEL thrombin (human)/ fibrinogen B02BC Topical / Within (human) Liquid Guidelines

Knight Therapeutics Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

Lantheus MI Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02243173 DEFINITY - perflutren V08DA Parenteral Within 150 MCL/MILLILITER /Suspensions Guidelines or Emulsions

Patented Medicines for Human Use Reported to the PMPRB in 2017 74

PMPRB Annual Report 2017

Leadiant Biosciences, Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

ADAGEN - pegademase bovine Parenteral Under 250 UNIT/MILLILITER /Solution Review

02241150 DEPOCYT - cytarabine L01BC Parenteral Within 10 MG/MILLILITER /Suspensions Guidelines or Emulsions

Leo Pharma Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02244126 DOVOBET 0.05/0.5 calcipotriol/betamethasone D05AX Topical Within dipropionate /Ointment Guidelines

02319012 DOVOBET GEL calcipotriol/betamethasone D05AX Topical /Gel Within 0.05/0.5 dipropionate Guidelines

02457393 ENSTILAR - calcipotriol/betamethasone D05AX Topical Within 0.55 MG/GRAM dipropionate /Aerosol Guidelines (foam)

02400987 PICATO 0.15 - ingenol mebutate D06BX Topical /Gel Within 70 MCG/TUBE Guidelines

02400995 PICATO 0.5 - ingenol mebutate D06BX Topical /Gel Within 235 MCG/TUBE Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 75

PMPRB Annual Report 2017

Lundbeck Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02239607 CELEXA - 20 MG/TAB citalopram hydrobromide N06AB Oral Solid Within /Tablet Guidelines

02239608 CELEXA - 40 MG/TAB citalopram hydrobromide N06AB Oral Solid Within /Tablet Guidelines

02263238 CIPRALEX - escitalopram oxalate N06AB Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02263254 CIPRALEX - escitalopram oxalate N06AB Oral Solid Subj. 20 MG/TAB /Tablet Investigation

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 - 10 MG/TAB memantine hydrochloride N06DX Oral Solid Within /Tablet Guidelines

02374803 SAPHRIS - 5 MG/TAB asenapine maleate N05AH Dental - Within Sublingual Guidelines Buccal /Sublingual tablets

02374811 SAPHRIS - asenapine maleate N05AH Dental - Does Not 10 MG/TAB Sublingual Trigger Buccal /Sublingual tablets

02432919 TRINTELLIX - vortioxetine hydrobromide N06AX Oral Solid Within 5 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 76

PMPRB Annual Report 2017

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 Medicinal Ingredient ATC Dosage Comments Status

02410702 ZAXINE - rifaximin A07AA Oral Solid Within 550 MG/TAB /Tablet Guidelines

Medexus Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02454769 METOJECT methotrexate sodium L04AX Parenteral Introduced VCU SUBCUTANEOUS - /Solution 17.5 MG/SYRINGE

02454866 METOJECT methotrexate sodium L04AX Parenteral Introduced VCU SUBCUTANEOUS - /Solution 20 MG/SYRINGE

02454777 METOJECT methotrexate sodium L04AX Parenteral Introduced VCU SUBCUTANEOUS - /Solution 22.5 MG/SYRINGE

02454874 METOJECT methotrexate sodium L04AX Parenteral Introduced VCU SUBCUTANEOUS - /Solution 25 MG/SYRINGE

Patented Medicines for Human Use Reported to the PMPRB in 2017 77

PMPRB Annual Report 2017

Medical Futures Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02373017 DURELA - tramadol hydrochloride N02AX Oral Solid Within 100 MG/CAPSULE /Modified Guidelines release capsules

02373025 DURELA - tramadol hydrochloride N02AX Oral Solid Within 200 MG/CAPSULE /Modified Guidelines release capsules

02373033 DURELA - tramadol hydrochloride N02AX Oral Solid Within 300 MG/CAPSULE /Modified Guidelines release capsules

Merck Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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 Within 50 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 78

PMPRB Annual Report 2017

02455323 BRENZYS - etanercept L04AB Parenteral Within 50 MG/MILLILITER /Solution Guidelines

02451816 BRIDION - sugammadex V03AB Parenteral VCU 100 MG/MILLILITER /Solution

02244265 CANCIDAS - caspofungin acetate J02AX Parenteral Expired Subj. 50 MG/VIAL /Powder for Investigation solution

02244266 CANCIDAS - caspofungin acetate J02AX Parenteral Expired Within 70 MG/VIAL /Powder for Guidelines solution

02387174 DIFICID - fidaxomicin A07AA Oral Solid Does Not 200 MG/TAB /Tablet Trigger

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 125MG/ aprepitant A04AD Oral Solid Within 80MG TRIPAK /Capsule Guidelines

02247521 EZETROL - ezetimibe C10AX Oral Solid Does Not 10 MG/TAB /Tablet Trigger

02283190 GARDASIL quadrivalent human J07BM Parenteral Within papillomavirus /Suspensions Guidelines recombinant vaccine or Emulsions

02437058 GARDASIL 9 human papillomavirus 9- J07BM Parenteral Subj. valent vaccine recombinant /Suspensions Investigation or Emulsions

02240351 INTEGRILIN - eptifibatide B01AC Parenteral Subj. 0.75 MG/MILLILITER /Solution Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 79

PMPRB Annual Report 2017

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 Subj. FREE - 25000000 /Solution Investigation 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 - raltegravir potassium J05AX Oral Solid Within 400 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 80

PMPRB Annual Report 2017

02465337 ISENTRESS HD - raltegravir potassium J05AX Oral Solid Introduced Under Review 600 MG/TAB /Tablet

02333872 JANUMET 50/1000 sitagliptin phosphate A10BD Oral Solid Within monohydrate/metformin /Tablet Guidelines hydrochloride

02333856 JANUMET 50/500 sitagliptin phosphate A10BD Oral Solid Within monohydrate/metformin /Tablet Guidelines hydrochloride

02333864 JANUMET 50/850 sitagliptin phosphate A10BD Oral Solid Within monohydrate/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 Subj. monohydrate/metformin /Modified Investigation hydrochloride release tablets

02416808 JANUMET XR sitagliptin phosphate A10BD Oral Solid Subj. 100/1000 monohydrate/metformin /Modified Investigation hydrochloride release tablets

02388839 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 25 MG/TAB monohydrate /Tablet Guidelines

02388847 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 50 MG/TAB monohydrate /Tablet Guidelines

02303922 JANUVIA - sitagliptin phosphate A10BH Oral Solid Within 100 MG/TAB monohydrate /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 81

PMPRB Annual Report 2017

02441152 KEYTRUDA - pembrolizumab L01XC Parenteral Within 50 MG/VIAL /Powder for Guidelines solution

02456869 KEYTRUDA - pembrolizumab L01XC Parenteral Introduced Under Review 25 MG/MILLILITER /Solution

02253186 NUVARING etonogestrel/ethinyl G02BB Vaginal Does Not 0.12/0.015 estradiol /Insert Trigger

02246030 PEGETRON 150 peginterferon alfa-2b + L03AB Other/Other Within ribavirin Guidelines

02254603 PEGETRON peginterferon alfa-2b + L03AB Other/Other Within REDIPEN 100 ribavirin Guidelines

02254638 PEGETRON peginterferon alfa-2b + L03AB Other/Other Within REDIPEN 120 ribavirin Guidelines

02254646 PEGETRON peginterferon alfa-2b + L03AB Other/Other Within REDIPEN 150 ribavirin Guidelines

02254581 PEGETRON peginterferon alfa-2b + L03AB Other/Other Within REDIPEN 80 ribavirin Guidelines

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

02242439 PUREGON - follitropin beta G03GA Parenteral VCU 50 UNIT/MILLILITER /Powder for solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 82

PMPRB Annual Report 2017

02242441 PUREGON - 100 follitropin beta G03GA Parenteral VCU UNIT/MILLILITER /Powder for solution

02243948 PUREGON follitropin beta G03GA Parenteral VCU /Solution

02243676 RECOMBIVAX HB hepatitis b vaccine (rdna) J07BC Parenteral Within THIMEROSAL FREE - /Suspensions Guidelines 10 MCG/MILLILITER or Emulsions

02245977 RECOMBIVAX HB hepatitis b vaccine (rdna) J07BC Parenteral Does Not THIMEROSAL FREE - /Suspensions Trigger 40 MCG/MILLILITER or Emulsions

02284413 ROTATEQ oral live rotavirus vaccine, J07BH Oral Liquid Expired Does Not pentavalent /Suspension Trigger

02247997 SINGULAIR - montelukast sodium R03DC Oral Solid Within 4 MG/POUCH /Effervescent Guidelines 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

02361752 ZENHALE 100/5 mometasone R03AK Pulmonary Within furoate/formoterol /Metered Guidelines fumarate dose preparations

02361760 ZENHALE 200/5 mometasone R03AK Pulmonary Within furoate/formoterol /Metered Guidelines fumarate dose preparations

Patented Medicines for Human Use Reported to the PMPRB in 2017 83

PMPRB Annual Report 2017

02361744 ZENHALE 50/5 mometasone R03AK Pulmonary Within furoate/formoterol /Metered Guidelines fumarate dose preparations

02451131 ZEPATIER 50/100 elbasvir/grazoprevir J05AX Oral Solid VCU /Tablet

02327619 ZOLINZA - vorinostat L01XX Oral Solid Within 100 MG/CAPSULE /Capsule Guidelines

Merus Labs International Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02273217 ENABLEX - darifenacin G04BD Oral Solid Within 7.5 MG/TAB /Tablet Guidelines

02273225 ENABLEX - darifenacin G04BD Oral Solid Within 15 MG/TAB /Tablet Guidelines

Merz Pharma Canada Ltd.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02371081 XEOMIN - 50 clostridium botulinum M03AX Parenteral Within UNIT/VIAL neurotoxin type A (150KD) /Powder for Guidelines solution

02324032 XEOMIN - clostridium botulinum M03AX Parenteral Within 100 UNIT/VIAL neurotoxin type A (150KD) /Powder for Guidelines solution

02383489 XEOMIN COSMETIC - clostridium botulinum M03AX Parenteral Within 100 UNIT/VIAL neurotoxin type A (150KD) /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 84

PMPRB Annual Report 2017

Novartis Pharmaceuticals Canada Inc.

DIN Brand Name Medicinal Ingredient 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 - 5 MG/TAB everolimus L04AA Oral Solid Within /Tablet Guidelines

02450267 AFINITOR - everolimus L04AA Oral Solid 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

02331624 AZARGA 1/0.5 brinzolamide/timolol S01ED Ophthalmic Within maleate /Suspension Guidelines

02238873 AZOPT - brinzolamide S01EC Ophthalmic Subj. 10 MG/MILLILITER /Suspension Investigation

02252716 CIPRODEX 3/ ciprofloxacin S02CA Otic Subj. 1 - 4 MG/MILLILITER hydrochloride/ /Suspension Investigation dexamethasone

Patented Medicines for Human Use Reported to the PMPRB in 2017 85

PMPRB Annual Report 2017

02243763 COMTAN - entacapone N04BX Oral Solid Does Not 200 MG/TAB /Tablet Trigger

02438070 COSENTYX - secukinumab L04AC Parenteral Within 150 MG/MILLILITER /Solution Guidelines

02278251 DUO TRAV PQ 0.04/5 travoprost/timolol maleate S01ED Ophthalmic VCU /Liquid

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

02302853 EXELON PATCH 10 - rivastigmine N06DA Topical Within 18 MG/PATCH /Patches Guidelines

02432803 EXELON PATCH 15 - rivastigmine N06DA Topical Within 27 MG/PATCH /Patches Guidelines

02302845 EXELON PATCH 5 - rivastigmine N06DA Topical Within 9 MG/PATCH /Patches Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 86

PMPRB Annual Report 2017

02229110 FAMVIR - famciclovir J05AB Oral Solid Expired Within 125 MG/TAB /Tablet Guidelines

02229129 FAMVIR - famciclovir J05AB Oral Solid Expired Does Not 250 MG/TAB /Tablet Trigger

02177102 FAMVIR - famciclovir J05AB Oral Solid Expired Within 500 MG/TAB /Tablet Guidelines

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

02344939 ILARIS - 150 MG/VIAL canakinumab L04AC Parenteral Within /Powder for Guidelines solution

02460351 ILARIS - canakinumab L04AC Parenteral Introduced Under Review 150 MG/MILLILITER /Solution

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

02457997 IZBA - travoprost S01EE Ophthalmic Introduced Within 0.03 MG/MILLILITER /Liquid Guidelines

02452219 JADENU - 90 MG/TAB deferasirox V03AC Oral Solid Does Not /Tablet Trigger

02452227 JADENU - deferasirox V03AC Oral Solid Does Not 180 MG/TAB /Tablet Trigger

02452235 JADENU - deferasirox V03AC Oral Solid Within 360 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 87

PMPRB Annual Report 2017

02388006 JAKAVI - 5 MG/TAB ruxolitinib L01XE Oral Solid Within /Tablet Guidelines

02434814 JAKAVI - 10 MG/TAB ruxolitinib L01XE Oral Solid Within /Tablet Guidelines

02388014 JAKAVI - 15 MG/TAB ruxolitinib L01XE Oral Solid Within /Tablet Guidelines

02388022 JAKAVI - 20 MG/TAB ruxolitinib L01XE Oral Solid Within /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

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 88

PMPRB Annual Report 2017

02376938 ONBREZ BREEZHALER indacaterol maleate R03AC Pulmonary Within - 75 MCG/CAPSULE /Powder Guidelines

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

02130181 PROLEUKIN - aldesleukin L03AC Parenteral Within 22000000 UNIT/VIAL /Powder for Guidelines solution

02302063 RASILEZ - aliskiren fumarate C09XA Oral Solid Within 150 MG/TAB /Tablet Guidelines

02302071 RASILEZ - aliskiren fumarate C09XA Oral Solid Within 300 MG/TAB /Tablet Guidelines

02332728 RASILEZ HCT aliskiren fumarate/ C09XA Oral Solid Within 150/12.5 hydrochlorothiazide /Tablet Guidelines

02332736 RASILEZ HCT 150/25 aliskiren fumarate/ C09XA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02332744 RASILEZ HCT aliskiren fumarate/ C09XA Oral Solid Within 300/12.5 hydrochlorothiazide /Tablet Guidelines

02332752 RASILEZ HCT 300/25 aliskiren fumarate/ C09XA Oral Solid Does Not hydrochlorothiazide /Tablet Trigger

02361825 REVOLADE - eltrombopag olamine B02BX Oral Solid Does Not 25 MG/TAB /Tablet Trigger

02361833 REVOLADE - eltrombopag olamine B02BX Oral Solid Subj. 50 MG/TAB /Tablet Investigation

02466236 RYDAPT - midostaurin L01XE Oral Solid Introduced Within 25 MG/CAPSULE /Capsule Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 89

PMPRB Annual Report 2017

00839191 SANDOSTATIN - octreotide H01CB Parenteral Subj. 0.05 MG/MILLILITER /Solution Investigation

00839205 SANDOSTATIN - octreotide H01CB Parenteral Subj. 0.1 MG/MILLILITER /Solution Investigation

02049392 SANDOSTATIN - octreotide H01CB Parenteral Subj. 0.2 MG/MILLILITER /Solution Investigation

00839213 SANDOSTATIN - octreotide H01CB Parenteral Subj. 0.5 MG/MILLILITER /Solution Investigation

02239323 SANDOSTATIN LAR - octreotide H01CB Parenteral Within 10 MG/VIAL /Modified Guidelines release injections

02239324 SANDOSTATIN LAR - octreotide H01CB Parenteral Within 20 MG/VIAL /Modified Guidelines release injections

02239325 SANDOSTATIN LAR - octreotide H01CB Parenteral Within 30 MG/VIAL /Modified Guidelines release injections

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 90

PMPRB Annual Report 2017

02437252 SIGNIFOR LAR - pasireotide H01CB Parenteral Within 20 MG/VIAL /Powder for Guidelines solution

02437260 SIGNIFOR LAR - pasireotide H01CB Parenteral Within 40 MG/VIAL /Powder for Guidelines solution

02437279 SIGNIFOR LAR - pasireotide H01CB Parenteral Within 60 MG/VIAL /Powder for Guidelines solution

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

02305941 STALEVO 100/25/200 levodopa/carbidopa/ N04BA Oral Solid Within 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

02337827 STALEVO levodopa/carbidopa/ N04BA Oral Solid Within 75/18.75/200 entacapone /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

Patented Medicines for Human Use Reported to the PMPRB in 2017 91

PMPRB Annual Report 2017

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

02318008 TRAVATAN Z - travoprost S01EE Ophthalmic Subj. 0.04 MG/MILLILITER /Liquid Investigation

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

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 R03AL Pulmonary Within BREEZHALER 110/50 maleate/glycopyrronium /Powder Guidelines bromide

02252260 VIGAMOX - moxifloxacin hydrochloride S01AX Ophthalmic Subj. 5 MG/MILLILITER /Liquid Investigation

02242367 VISUDYNE - verteporfin L01XX Parenteral Within 15 MG/VIAL /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 92

PMPRB Annual Report 2017

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

02459787 XOLAIR - omalizumab R03DX Parenteral Introduced Within 75 MG/SYRINGE /Solution Guidelines

02459795 XOLAIR - omalizumab R03DX Parenteral Introduced Within 150 MG/SYRINGE /Solution Guidelines

02248296 ZOMETA - zoledronic acid M05BA Parenteral Within 4 MG/VIAL /Solution Guidelines

02436779 ZYKADIA - ceritinib L01XE Oral Solid Within 150 MG/CAPSULE /Capsule Guidelines

Novo Nordisk Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02460408 FIASP - insulin aspart A10AB Parenteral Introduced/Expired Within 100 UNIT/ /Solution Guidelines MILLILITER

02460424 FIASP FLEXTOUCH - insulin aspart A10AB Parenteral Introduced/Expired Within 100 UNIT/ /Solution Guidelines MILLILITER

02460416 FIASP PENFILL - insulin aspart A10AB Parenteral Introduced/Expired Within 100 UNIT/ /Solution Guidelines MILLILITER

02417103 NIASTASE RT - 1 eptacog alfa (activated) B02BD Parenteral Within MG/VIAL /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 93

PMPRB Annual Report 2017

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 Expired Does Not NORDIFLEX - /Solution Trigger 5 MG/PEN

02334860 NORDITROPIN somatropin H01AC Parenteral Expired Within NORDIFLEX - /Solution Guidelines 10 MG/PEN

02334879 NORDITROPIN somatropin H01AC Parenteral Expired Within NORDIFLEX - /Solution Guidelines 15 MG/PEN

02265435 NOVOMIX 30 insulin aspart/insulin A10AD Parenteral Expired Does Not PENFILL - aspart protamine /Solution Trigger 100 UNIT/ MILLILITER

02245397 NOVORAPID - insulin aspart A10AB Parenteral Expired Within 100 UNIT/ /Solution Guidelines MILLILITER

02377209 NOVORAPID insulin aspart A10AB Parenteral Expired Does Not FLEXTOUCH - /Solution Trigger 100 UNIT/ MILLILITER

02244353 NOVORAPID insulin aspart A10AB Parenteral Expired Within PENFILL - /Solution Guidelines 100 UNIT/ MILLILITER

02437899 SAXENDA - liraglutide A10BX Parenteral Within 6 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 94

PMPRB Annual Report 2017

02389975 TRETTEN - catridecacog B02BD Parenteral Within 15 MG/VIAL /Powder for Guidelines solution

02351064 VICTOZA - liraglutide A10BX Parenteral Within 6 MG/MILLILITER /Solution Guidelines

Octapharma Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02432951 NUWIQ - 250 IU/VIAL antihemophilic factor B02BD Parenteral Does Not (recombinant, b-domain /Powder for Trigger deleted) solution

02432978 NUWIQ - 500 IU/VIAL antihemophilic factor B02BD Parenteral Subj. (recombinant, b-domain /Powder for Investigation deleted) solution

02432986 NUWIQ - antihemophilic factor B02BD Parenteral Within 1000 IU/VIAL (recombinant, b-domain /Powder for Guidelines deleted) solution

02432994 NUWIQ - antihemophilic factor B02BD Parenteral Does Not 2000 IU/VIAL (recombinant, b-domain /Powder for Trigger deleted) solution

Otsuka Canada Pharmaceutical Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02420864 ABILIFY MAINTENA - aripiprazole N05AX Parenteral Within 300 MG/VIAL /Suspensions Guidelines or Emulsions

Patented Medicines for Human Use Reported to the PMPRB in 2017 95

PMPRB Annual Report 2017

02420872 ABILIFY MAINTENA - aripiprazole N05AX Parenteral Within 400 MG/VIAL /Suspensions Guidelines or Emulsions

02461749 REXULTI - brexpiprazole N05AX Oral Solid Introduced Within 0.25 MG/TAB /Tablet Guidelines

02461757 REXULTI - brexpiprazole N05AX Oral Solid Introduced Within 0.5 MG/TAB /Tablet Guidelines

02461765 REXULTI - 1 MG/TAB brexpiprazole N05AX Oral Solid Introduced Within /Tablet Guidelines

02461773 REXULTI - 2 MG/TAB brexpiprazole N05AX Oral Solid Introduced Within /Tablet Guidelines

02461781 REXULTI - 3 MG/TAB brexpiprazole N05AX Oral Solid Introduced Within /Tablet Guidelines

02461803 REXULTI - 4 MG/TAB brexpiprazole N05AX Oral Solid Introduced Within /Tablet Guidelines

Paladin Labs Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02364174 ABSTRAL - fentanyl citrate N02AB Dental - Within 100 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02364182 ABSTRAL - fentanyl citrate N02AB Dental - Within 200 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

Patented Medicines for Human Use Reported to the PMPRB in 2017 96

PMPRB Annual Report 2017

02364190 ABSTRAL - fentanyl citrate N02AB Dental - Within 300 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02364204 ABSTRAL - fentanyl citrate N02AB Dental - Within 400 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02364220 ABSTRAL - fentanyl citrate N02AB Dental - Within 800 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02242980 ANTIZOL - fomepizole V03AB Parenteral Subj. 1 G/MILLILITER /Solution Investigation

02437333 ICLUSIG - 15 MG/TAB ponatinib hydrochloride L01XE Oral Solid Within /Tablet Guidelines

02437341 ICLUSIG - 45 MG/TAB ponatinib hydrochloride L01XE Oral Solid Within /Tablet Guidelines

02247698 METADOL - methadone hydrochloride N07BC Oral Solid Within 1 MG/TAB /Tablet Guidelines

02247699 METADOL - methadone hydrochloride N07BC Oral Solid Within 5 MG/TAB /Tablet Guidelines

02247700 METADOL - methadone hydrochloride N07BC Oral Solid Within 10 MG/TAB /Tablet Guidelines

02247701 METADOL - methadone hydrochloride N07BC Oral Solid Within 25 MG/TAB /Tablet Guidelines

02459132 MOVAPO - apomorphine N04BC Parenteral Introduced Under Review 10 MG/MILLILITER hydrochloride /Solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 97

PMPRB Annual Report 2017

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

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

02398257 SILENOR - 3 MG/TAB doxepin N06AA Oral Solid Introduced Within /Tablet Guidelines

02398265 SILENOR - 6 MG/TAB doxepin N06AA Oral Solid Introduced Within /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 98

PMPRB Annual Report 2017

02280248 TESTIM 1% - testosterone G03BA Topical /Gel Within 5 GM/TUBE Guidelines

02296381 TRIDURAL - tramadol hydrochloride N02AX Oral Solid VCU 100 MG/TAB * /Modified release tablets

02296403 TRIDURAL - tramadol hydrochloride N02AX Oral Solid VCU 200 MG/TAB /Modified release tablets

02296411 TRIDURAL - tramadol hydrochloride N02AX Oral Solid VCU 300 MG/TAB /Modified release tablets

02411849 VEREGEN - sinecatechins D06BB Topical Does Not 100 MG/GRAM /Ointment Trigger

02388316 XIAFLEX - collagenase clostridium M09AB Parenteral Subj. 0.9 MG/VIAL histolyticum /Powder for Investigation solution

*Note: Separate and distinct from the VCU signed by Paladin in 2017 for Tridural 100, 200 and 300, Tridural 100 triggered the investigation criteria as of December 31, 2017. That investigation is still ongoing as of the time of this report.

Pediapharm Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02459655 OTIXAL 3/0.25 ciprofloxacin/flucinolone S02CA Otic /Solution Introduced Under Review acetonide

Patented Medicines for Human Use Reported to the PMPRB in 2017 99

PMPRB Annual Report 2017

Pendopharm, Division of Pharmascience Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02330725 VIBATIV - telavancin hydrochloride J01XA Parenteral Within 750 MG/VIAL /Powder for Guidelines solution

Pfizer Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

01947664 ACCUPRIL - 5 quinapril hydrochloride C09AA Oral Solid Does Not MG/TAB /Tablet Trigger

01947672 ACCUPRIL - 10 quinapril hydrochloride C09AA Oral Solid Does Not MG/TAB /Tablet Trigger

01947680 ACCUPRIL - 20 quinapril hydrochloride C09AA Oral Solid Does Not MG/TAB /Tablet Trigger

01947699 ACCUPRIL - 40 quinapril hydrochloride C09AA Oral Solid Does Not MG/TAB /Tablet Trigger

02237367 ACCURETIC 10/12.5 quinapril hydrochloride/ C09BA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02237368 ACCURETIC 20/12.5 quinapril hydrochloride/ C09BA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02237369 ACCURETIC 20/25 quinapril hydrochloride/ C09BA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02232043 ARICEPT - 5 MG/TAB donepezil hydrochloride N06DA Oral Solid Subj. /Tablet Investigation

02232044 ARICEPT - 10 MG/TAB donepezil hydrochloride N06DA Oral Solid Within

Patented Medicines for Human Use Reported to the PMPRB in 2017 100

PMPRB Annual Report 2017

/Tablet Guidelines

02269457 ARICEPT RDT - 5 donepezil hydrochloride N06DA Oral Solid Does Not MG/TAB /Tablet Trigger

02269465 ARICEPT RDT - 10 donepezil hydrochloride N06DA Oral Solid Does Not MG/TAB /Tablet Trigger

02242705 AROMASIN - 25 exemestane L02BG Oral Solid Does Not MG/TAB /Tablet Trigger

02392984 BENEFIX - 3000 coagulation factor ix B02BD Parenteral Within UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293773 BENEFIX - 500 coagulation factor ix B02BD Parenteral Within UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293781 BENEFIX - 1000 coagulation factor ix B02BD Parenteral Within UNIT/VIAL (recombinant) /Powder for Guidelines solution

02293803 BENEFIX - 2000 coagulation factor ix B02BD Parenteral Within UNIT/VIAL (recombinant) /Powder for Guidelines solution

02419149 BOSULIF - 100 bosutinib L01XE Oral Solid Within MG/TAB /Tablet Guidelines

02419157 BOSULIF - 500 bosutinib L01XE Oral Solid Within MG/TAB /Tablet Guidelines

02273284 CADUET 10/10 amlodipine C10BX Oral Solid Subj. besylate/atorvastatin /Tablet Investigation calcium

02273292 CADUET 10/20 amlodipine C10BX Oral Solid Subj. besylate/atorvastatin /Tablet Investigation calcium

Patented Medicines for Human Use Reported to the PMPRB in 2017 101

PMPRB Annual Report 2017

02273306 CADUET 10/40 amlodipine C10BX Oral Solid Does Not besylate/atorvastatin /Tablet Trigger calcium

02273314 CADUET 10/80 amlodipine C10BX Oral Solid Does Not besylate/atorvastatin /Tablet Trigger calcium

02273233 CADUET 5/10 amlodipine C10BX Oral Solid Does Not besylate/atorvastatin /Tablet Trigger calcium

02273241 CADUET 5/20 amlodipine C10BX Oral Solid Subj. besylate/atorvastatin /Tablet Investigation calcium

02273268 CADUET 5/40 amlodipine C10BX Oral Solid Subj. besylate/atorvastatin /Tablet Investigation calcium

02273276 CADUET 5/80 amlodipine C10BX Oral Solid Does Not besylate/atorvastatin /Tablet Trigger calcium

02239941 CELEBREX - 100 celecoxib M01AH Oral Solid Subj. MG/CAPSULE /Capsule Investigation

02239942 CELEBREX - 200 celecoxib M01AH Oral Solid Within MG/CAPSULE /Capsule Guidelines

02291177 CHAMPIX - 0.5 varenicline tartrate N07BA Oral Solid Does Not MG/TAB /Tablet Trigger

02291185 CHAMPIX - 1 MG/TAB varenicline tartrate N07BA Oral Solid Within /Tablet Guidelines

02298309 CHAMPIX varenicline tartrate N07BA Oral Solid Within /Tablet Guidelines

02132680 COLESTID - 1000 colestipol hydrochloride C10AC Oral Solid Expired Within

Patented Medicines for Human Use Reported to the PMPRB in 2017 102

PMPRB Annual Report 2017

MG/TAB /Tablet Guidelines

02132699 COLESTID ORANGE - colestipol hydrochloride C10AC Oral Solid Expired Does Not 7500 MG/DOSE /Effervescent Trigger granules

02239064 DETROL - 1 MG/TAB tolterodine tartrate G04BD Oral Solid Within /Tablet Guidelines

02239065 DETROL - 2 MG/TAB tolterodine tartrate G04BD Oral Solid Does Not /Tablet Trigger

02244612 DETROL LA - 2 tolterodine L-tartrate G04BD Oral Solid Within MG/CAPSULE /Modified Guidelines release capsules

02244613 DETROL LA - 4 tolterodine L-tartrate G04BD Oral Solid Subj. MG/CAPSULE /Modified Investigation release capsules

02237279 EFFEXOR XR - 37.5 venlafaxine hydrochloride N06AA Oral Solid Expired Does Not MG/CAPSULE /Modified Trigger release capsules

02237280 EFFEXOR XR - 75 venlafaxine hydrochloride N06AA Oral Solid Expired Does Not MG/CAPSULE /Modified Trigger release capsules

02237282 EFFEXOR XR - 150 venlafaxine hydrochloride N06AA Oral Solid Expired Does Not MG/CAPSULE /Modified Trigger release capsules

02425637 ELELYSO - 200 taliglucerase alpha A16AB Parenteral Within IU/VIAL /Solution Guidelines

02330695 ERAXIS (WITHOUT anidulafungin J02AX Parenteral Within SOLVENT) - 100 /Powder for

Patented Medicines for Human Use Reported to the PMPRB in 2017 103

PMPRB Annual Report 2017

MG/VIAL solution Guidelines

02401762 GENOTROPIN - 0.6 somatropin H01AC Parenteral Does Not MG/SYRINGE /Powder for Trigger solution

02401770 GENOTROPIN - 0.8 somatropin H01AC Parenteral Within MG/SYRINGE /Powder for Guidelines solution

02401789 GENOTROPIN - 1 somatropin H01AC Parenteral Within MG/SYRINGE /Powder for Guidelines solution

02401797 GENOTROPIN - 1.2 somatropin H01AC Parenteral Subj. MG/SYRINGE /Powder for Investigation solution

02401800 GENOTROPIN - 1.4 somatropin H01AC Parenteral Does Not MG/SYRINGE /Powder for Trigger solution

02401819 GENOTROPIN - 1.6 somatropin H01AC Parenteral Does Not MG/SYRINGE /Powder for Trigger solution

02401827 GENOTROPIN - 1.8 somatropin H01AC Parenteral Does Not MG/SYRINGE /Powder for Trigger solution

02401835 GENOTROPIN - 2 somatropin H01AC Parenteral Within MG/SYRINGE /Powder for Guidelines solution

02401703 GENOTROPIN - 5.3 somatropin H01AC Parenteral Within MG/PEN /Powder for Guidelines solution

02401711 GENOTROPIN - 12 somatropin H01AC Parenteral Does Not MG/PEN /Powder for Trigger solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 104

PMPRB Annual Report 2017

02453150 IBRANCE - 75 palbociclib L01XE Oral Solid Subj. MG/CAPSULE /Capsule Investigation

02453169 IBRANCE - 100 palbociclib L01XE Oral Solid Subj. MG/CAPSULE /Capsule Investigation

02453177 IBRANCE - 125 palbociclib L01XE Oral Solid Subj. MG/CAPSULE /Capsule Investigation

02389630 INLYTA - 1 MG/TAB axitinib L01XE Oral Solid Within /Tablet Guidelines

02389649 INLYTA - 5 MG/TAB axitinib L01XE Oral Solid Within /Tablet Guidelines

02410419 IRINOTECAN - 20 irinotecan hydrochloride L01XX Parenteral Subj. MG/MILLILITER trihydrate /Solution Investigation

02230711 LIPITOR - 10 MG/TAB atorvastatin calcium C10AA Oral Solid Within /Tablet Guidelines

02230713 LIPITOR - 20 MG/TAB atorvastatin calcium C10AA Oral Solid Within /Tablet Guidelines

02230714 LIPITOR - 40 MG/TAB atorvastatin calcium C10AA Oral Solid Does Not /Tablet Trigger

02243097 LIPITOR - 80 MG/TAB atorvastatin calcium C10AA Oral Solid Within /Tablet Guidelines

02268418 LYRICA - 25 pregabalin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02268426 LYRICA - 50 pregabalin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02268434 LYRICA - 75 pregabalin N03AX Oral Solid Does Not MG/CAPSULE /Capsule Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 105

PMPRB Annual Report 2017

02268450 LYRICA - 150 pregabalin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02268477 LYRICA - 225 pregabalin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02268485 LYRICA - 300 pregabalin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02245057 NEISVAC-C meningococcal group c-tt J07AH Parenteral Within conjugate vaccine, /Suspensions Guidelines adsorbed or Emulsions

02084260 NEURONTIN - 100 gabapentin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02084279 NEURONTIN - 300 gabapentin N03AX Oral Solid Within MG/CAPSULE /Capsule Guidelines

02084287 NEURONTIN - 400 gabapentin N03AX Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02239717 NEURONTIN - 600 gabapentin N03AX Oral Solid Within MG/TAB /Tablet Guidelines

02239718 NEURONTIN - 800 gabapentin N03AX Oral Solid Within MG/TAB /Tablet Guidelines

02402904 NIMENRIX - 5 meningococcal J07AH Parenteral Within MCG/DOSE polysaccharide groups a, c, /Powder for Guidelines w-135 and y conjugate solution vaccine

00878928 NORVASC - 5 amlodipine besylate C08CA Oral Solid Does Not MG/TAB /Tablet Trigger

00878936 NORVASC - 10 amlodipine besylate C08CA Oral Solid Within MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 106

PMPRB Annual Report 2017

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

02339366 PRECEDEX - 100 dexmedetomidine N05CM Parenteral Subj. MCG/MILLILITER hydrochloride /Solution Investigation

02335204 PREVNAR 13 pneumococcal 13-valent J07AL Parenteral Within conjugate vaccine /Suspensions Guidelines or Emulsions

02321092 PRISTIQ - 50 MG/TAB desvenlafaxine succinate N06AX Oral Solid Within /Modified Guidelines release tablets

02321106 PRISTIQ - 100 desvenlafaxine succinate N06AX Oral Solid Within MG/TAB /Modified Guidelines release tablets

02243237 RAPAMUNE - 1 sirolimus L04AA Oral Liquid Does Not MG/MILLILITER /Solution Trigger

02247111 RAPAMUNE - 1 sirolimus L04AA Oral Solid Does Not MG/TAB /Tablet Trigger

02279401 REVATIO - 20 sildenafil citrate G04BE Oral Solid Within MG/TAB /Tablet Guidelines

02341611 REVATIO IV - 0.8 sildenafil citrate G04BE Parenteral Within MG/MILLILITER /Solution Guidelines

02272199 SOMAVERT - 10 pegvisomant H01AX Parenteral Within MG/VIAL /Powder for Guidelines solution

02272202 SOMAVERT - 15 pegvisomant H01AX Parenteral Within MG/VIAL /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 107

PMPRB Annual Report 2017

02272210 SOMAVERT - 20 pegvisomant H01AX Parenteral Within MG/VIAL /Powder for Guidelines solution

02448831 SOMAVERT - 25 pegvisomant H01AX Parenteral Within MG/VIAL /Powder for Guidelines solution

02448858 SOMAVERT - 30 pegvisomant H01AX Parenteral Within MG/VIAL /Powder for Guidelines solution

02280795 SUTENT - 12.5 sunitinib malate L01XE Oral Solid Within MG/CAPSULE /Capsule Guidelines

02280809 SUTENT - 25 sunitinib malate L01XE Oral Solid Within MG/CAPSULE /Capsule Guidelines

02280817 SUTENT - 50 sunitinib malate L01XE Oral Solid Within MG/CAPSULE /Capsule Guidelines

02304104 TORISEL - 25 temsirolimus L01XE Parenteral Does Not MG/VIAL /Solution Trigger

02380021 TOVIAZ - 4 MG/TAB fesoterodine fumarate G04BD Oral Solid Within /Modified Guidelines release tablets

02380048 TOVIAZ - 8 MG/TAB fesoterodine fumarate G04BD Oral Solid Within /Modified Guidelines release tablets

02285401 TYGACIL - 50 tigecycline J01AA Parenteral Within MG/VIAL /Powder for Guidelines solution

02279991 VFEND - 40 voriconazole J02AC Oral Liquid Does Not MG/MILLILITER /Powder for Trigger suspension

Patented Medicines for Human Use Reported to the PMPRB in 2017 108

PMPRB Annual Report 2017

02256460 VFEND - 50 MG/TAB voriconazole J02AC Oral Solid Subj. /Tablet Investigation

02256479 VFEND - 200 MG/TAB voriconazole J02AC Oral Solid Subj. /Tablet Investigation

02256487 VFEND - 200 voriconazole J02AC Parenteral Within MG/VIAL /Powder for Guidelines solution

02239766 VIAGRA - 25 MG/TAB sildenafil citrate G04BE Oral Solid Within /Tablet Guidelines

02239767 VIAGRA - 50 MG/TAB sildenafil citrate G04BE Oral Solid Within /Tablet Guidelines

02239768 VIAGRA - 100 sildenafil citrate G04BE Oral Solid Within MG/TAB /Tablet Guidelines

02384256 XALKORI - 200 crizotinib L01XE Oral Solid Within MG/CAPSULE /Capsule Guidelines

02384264 XALKORI - 250 crizotinib L01XE Oral Solid Within MG/CAPSULE /Capsule Guidelines

02423898 XELJANZ - 5 MG/TAB tofacitinib L04AA Oral Solid Within /Tablet Guidelines

02309483 XYNTHA - 250 moroctocog alfa B02BD Parenteral Subj. UNIT/VIAL /Powder for Investigation solution

02309491 XYNTHA - 500 moroctocog alfa B02BD Parenteral Subj. UNIT/VIAL /Powder for Investigation solution

02374072 XYNTHA SOLOFUSE - moroctocog alfa B02BD Parenteral Subj. 1000 UNIT/SYRINGE /Powder for Investigation solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 109

PMPRB Annual Report 2017

02374080 XYNTHA SOLOFUSE - moroctocog alfa B02BD Parenteral Subj. 2000 UNIT/SYRINGE /Powder for Investigation solution

02374099 XYNTHA SOLOFUSE - moroctocog alfa B02BD Parenteral Does Not 3000 UNIT/SYRINGE /Powder for Trigger solution

02298597 ZELDOX - 20 ziprasidone hydrochloride N05AE Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02298600 ZELDOX - 40 ziprasidone hydrochloride N05AE Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02298619 ZELDOX - 60 ziprasidone hydrochloride N05AE Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02298627 ZELDOX - 80 ziprasidone hydrochloride N05AE Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02223716 ZITHROMAX - 20 azithromycin J01FA Oral Liquid Within MG/MILLILITER /Powder for Guidelines suspension

02223724 ZITHROMAX - 40 azithromycin J01FA Oral Liquid Within MG/MILLILITER /Powder for Guidelines suspension

02212021 ZITHROMAX - 250 azithromycin J01FA Oral Solid Within MG/TAB /Tablet Guidelines

02239952 ZITHROMAX IV - 500 azithromycin J01FA Parenteral Within MG/VIAL /Powder for Guidelines solution

02132702 ZOLOFT - 25 sertraline hydrochloride N06AB Oral Solid Within MG/CAPSULE /Capsule Guidelines

01962817 ZOLOFT - 50 sertraline hydrochloride N06AB Oral Solid Does Not MG/CAPSULE /Capsule Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 110

PMPRB Annual Report 2017

01962779 ZOLOFT - 100 sertraline hydrochloride N06AB Oral Solid Does Not MG/CAPSULE /Capsule Trigger

02243686 ZYVOXAM - 20 linezolid J01XX Oral Liquid Within MG/MILLILITER /Powder for Guidelines suspension

02243684 ZYVOXAM - 600 linezolid J01XX Oral Solid Within MG/TAB /Tablet Guidelines

02243685 ZYVOXAM - 2 linezolid J01XX Parenteral Does Not MG/MILLILITER /Solution Trigger

Pharmascience Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02406764 CYTARABINE - cytarabine L01BC Parenteral Does Not 20 MG/MILLILITER /Solution Trigger

02406772 CYTARABINE - cytarabine L01BC Parenteral Within 100 MG/MILLILITER /Solution Guidelines

Pierre Fabre Dermo-Cosmétique Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02457857 HEMANGIOL - propranolol C07AA Oral Liquid Introduced Does Not 3.75 MG/MILLILITER hydrochloride /Solution Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 111

PMPRB Annual Report 2017

PTC Therapeutics International Limited

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

TRANSLARNA - 02252716 M09AX Oral Solid Introduced Within 125 MG/POUCH ataluren /Effervescent Guidelines granules

TRANSLARNA - ataluren M09AX Oral Solid Within 250 MG/POUCH /Effervescent Guidelines granules

Purdue Pharma

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02468735 AKYNZEO 300/0.5 netupitant/palonosetron A04AA Oral Solid Introduced Under Review /Capsule

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

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

02277166 BIPHENTIN - methylphenidate N06BA Oral Solid Within 10 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277131 BIPHENTIN - methylphenidate N06BA Oral Solid Within 15 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277158 BIPHENTIN - methylphenidate N06BA Oral Solid Within 20 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

Patented Medicines for Human Use Reported to the PMPRB in 2017 112

PMPRB Annual Report 2017

02277174 BIPHENTIN - methylphenidate N06BA Oral Solid Within 30 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277182 BIPHENTIN - methylphenidate N06BA Oral Solid Within 40 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277190 BIPHENTIN - methylphenidate N06BA Oral Solid Within 50 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277204 BIPHENTIN - methylphenidate N06BA Oral Solid Within 60 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02277212 BIPHENTIN - methylphenidate N06BA Oral Solid Within 80 MG/CAPSULE hydrochloride /Modified Guidelines release capsules

02450771 BUTRANS - buprenorphine N02AE Topical Does Not 15 MG/PATCH /Patches Trigger

02341212 BUTRANS 10 - buprenorphine N02AE Topical Does Not 10 MG/PATCH /Patches Trigger

02341220 BUTRANS 20 - buprenorphine N02AE Topical Does Not 20 MG/PATCH /Patches Trigger

02341174 BUTRANS 5 - buprenorphine N02AE Topical Within 5 MG/PATCH /Patches Guidelines

02231934 OXY-IR - 5 MG/TAB oxycodone hydrochloride N02AA Oral Solid Does Not /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 113

PMPRB Annual Report 2017

02240131 OXY-IR - 10 MG/TAB oxycodone hydrochloride N02AA Oral Solid Does Not /Tablet Trigger

02240132 OXY-IR - 20 MG/TAB oxycodone hydrochloride N02AA Oral Solid Within /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 Does Not 20 MG/TAB /Modified Trigger release tablets

02372541 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Within 30 MG/TAB /Modified Guidelines release tablets

02372568 OXYNEO - oxycodone hydrochloride N02AA Oral Solid Subj. 40 MG/TAB /Modified Investigation release tablets

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 114

PMPRB Annual Report 2017

02339609 TARGIN 10/5 oxycodone N02AA Oral Solid Does Not hydrochloride/naloxone /Modified Trigger hydrochloride release tablets

02339617 TARGIN 20/10 oxycodone N02AA Oral Solid Does Not hydrochloride/naloxone /Modified Trigger hydrochloride release tablets

02339625 TARGIN 40/20 oxycodone N02AA Oral Solid Does Not hydrochloride/naloxone /Modified Trigger hydrochloride release tablets

02387425 TARGIN 5/2.5 oxycodone N02AA Oral Solid Does Not hydrochloride/naloxone /Modified Trigger hydrochloride release tablets

Sandoz Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02246533 ANGIOMAX - bivalirudin B01AE Parenteral Does Not 250 MG/VIAL /Powder for Trigger solution

Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02463261 CERDELGA - eliglustat tartrate A16AX Oral Solid Introduced Subj. 84 MG/CAPSULE /Capsule Investigation

Patented Medicines for Human Use Reported to the PMPRB in 2017 115

PMPRB Annual Report 2017

Sanofi Pasteur Limited

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02279924 MENACTRA meningococcal J07AH Parenteral Within polysaccharide /Solution Guidelines diphtheria toxoid conjugate vaccine

Sanofi-Aventis Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02464349 ADLYXINE lixisenatide A10BJ Parenteral Introduced Under /Kit Review

02464276 ADLYXINE - lixisenatide A10BJ Parenteral Introduced Under 0.05 MG/MILLILITER /Solution Review

02464284 ADLYXINE - lixisenatide A10BJ Parenteral Introduced Under 0.1 MG/MILLILITER /Solution Review

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 - 10 MG/TAB leflunomide L04AA Oral Solid Expired Does Not /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 116

PMPRB Annual Report 2017

02241889 ARAVA - 20 MG/TAB leflunomide L04AA Oral Solid Expired Does Not /Tablet Trigger

02241818 AVALIDE 150/12.5 irbesartan/ C09DA Oral Solid Within hydrochlorothiazide /Tablet Guidelines

02241819 AVALIDE 300/12.5 irbesartan/ C09DA Oral Solid Within hydrochlorothiazide /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

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 - 20 MG/VIAL clofarabine L01BB Parenteral Within /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

Patented Medicines for Human Use Reported to the PMPRB in 2017 117

PMPRB Annual Report 2017

02296284 ELOXATIN - oxaliplatine L01XA Parenteral Within 5 MG/MILLILITER /Solution Guidelines

02369524 JEVTANA - cabazitaxel L01CD Parenteral Within 60 MG/VIAL /Solution Guidelines

02460521 KEVZARA - sarilumab L04AC Parenteral Introduced Within 150 MG/SYRINGE /Solution Guidelines

02460548 KEVZARA - sarilumab L04AC Parenteral Introduced Within 200 MG/SYRINGE /Solution Guidelines

02245689 LANTUS - insulin glargine A10AE Parenteral Within 100 UNIT/MILLILITER /Solution Guidelines

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

LEUKINE - sargramostim L03AA Parenteral Introduced Subj. 250 MCG/MILLILITER /Solution Investigation

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 - 75 MG/TAB clopidogrel bisulfate B01AC Oral Solid Within /Tablet Guidelines

02330555 PLAVIX - 300 MG/TAB clopidogrel bisulfate B01AC Oral Solid Within /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 118

PMPRB Annual Report 2017

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 Expired Within /Modified Guidelines release tablets

Seattle Genetics Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02401347 ADCETRIS - brentuximab vedotin L01XC Parenteral/ Expired Within 50 MG/VIAL Powder for Guidelines solution

Seqirus Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02362384 FLUAD - 45 influenza vaccine, surface J07BB Parenteral Does Not MCG/DOSE antigen, inactivated /Suspensions Trigger or Emulsions

02434881 FLUAD PEDIATRIC - influenza vaccine, surface J07BB Parenteral Within 22.5 MCG/DOSE antigen, inactivated /Suspensions Guidelines or Emulsions

Patented Medicines for Human Use Reported to the PMPRB in 2017 119

PMPRB Annual Report 2017

Servier Canada Inc.

DIN Brand Name Medicinal Ingredient 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 HD perindopril C09BA Oral Solid Within 8/2.5 erbumine/indapamide /Tablet Guidelines

02246568 COVERSYL PLUS LD perindopril C09BA Oral Solid Within 2/0.625 erbumine/indapamide /Tablet Guidelines

02242987 DIAMICRON MR - gliclazide A10BB Oral Solid Within 30 MG/TAB /Modified Guidelines release tablets

02356422 DIAMICRON MR - gliclazide A10BB Oral Solid Within 60 MG/TAB /Modified Guidelines release tablets

02459973 LANCORA - ivabradine C01EB Oral Solid Does Not 5 MG/TAB /Tablet Trigger

02459981 LANCORA - ivabradine C01EB Oral Solid Does Not 7.5 MG/TAB /Tablet Trigger

02458640 LIXIANA - 15 MG/TAB edoxaban B01AF Oral Solid Introduced Within /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 120

PMPRB Annual Report 2017

02458659 LIXIANA - 30 MG/TAB edoxaban B01AF Oral Solid Introduced Within /Tablet Guidelines

02458667 LIXIANA - 60 MG/TAB edoxaban B01AF Oral Solid Introduced Within /Tablet Guidelines

02451557 VIACORAM 14/10 perindopril C09BB Oral Solid Within arginine/amlodipine /Tablet Guidelines

02451530 VIACORAM 3.5/2.5 perindopril C09BB Oral Solid Within arginine/amlodipine /Tablet Guidelines

02451549 VIACORAM 7/5 perindopril C09BB Oral Solid Within arginine/amlodipine /Tablet Guidelines

Shire Human Genetic Therapies, Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

REPLAGAL - agalsidase alfa A16AB Parenteral Expired Subj. 3.5 MG/VIAL /Solution Investigation

02357119 VPRIV - velaglucerase alfa A16AB Parenteral Within 400 UNIT/VIAL /Powder for Guidelines solution

Shire Pharma Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02248808 ADDERALL XR - mixed salts amphetamine N06BA Oral Solid Within 5 MG/CAPSULE /Modified Guidelines release capsules

Patented Medicines for Human Use Reported to the PMPRB in 2017 121

PMPRB Annual Report 2017

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

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 Does Not 250 MG/TAB hydrate /Tablet Trigger

02287153 FOSRENOL - lanthanum carbonate V03AE Oral Solid Within 500 MG/TAB hydrate /Tablet Guidelines

02287161 FOSRENOL - lanthanum carbonate V03AE Oral Solid Does Not 750 MG/TAB hydrate /Tablet Trigger

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 122

PMPRB Annual Report 2017

02409119 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Within 2 MG/TAB /Modified Guidelines release tablets

02409127 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Within 3 MG/TAB /Modified Guidelines release tablets

02409135 INTUNIV XR - guanfacine hydrochloride C02AC Oral Solid Within 4 MG/TAB /Modified Guidelines release tablets

02297558 MEZAVANT - mesalamine A07EC Oral Solid Within 1.2 G/TAB /Modified Guidelines release tablets

02467135 ONIVYDE - irinotecan hydrochloride L01XX Parenteral Introduced Under Review 4.3 MG/MILLILITER trihydrate /Solution

02445727 REVESTIVE - teduglutide A16AX Oral Liquid Within 5 MG/VIAL /Powder for Guidelines solution

02458071 VYVANSE - lisdexamfetamine N06BA Oral Solid Introduced Does Not 70 MG/CAPSULE dimesylate /Capsule Trigger

02439603 VYVANSE - lisdexamfetamine N06BA Oral Solid Within 10 MG/CAPSULE dimesylate /Capsule Guidelines

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 123

PMPRB Annual Report 2017

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

Sunovion Pharmaceuticals Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02426862 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 200 MG/TAB /Tablet Guidelines

02426870 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 400 MG/TAB /Tablet Guidelines

02426889 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 600 MG/TAB /Tablet Guidelines

02426897 APTIOM - eslicarbazepine acetate N03AF Oral Solid Within 800 MG/TAB /Tablet Guidelines

02299909 CUBICIN - daptomycin J01XX Parenteral Within 500 MG/VIAL /Powder for Guidelines solution

02422050 LATUDA - 20 MG/TAB lurasidone hydrochloride N05AE Oral Solid Within /Tablet Guidelines

02387751 LATUDA - 40 MG/TAB lurasidone hydrochloride N05AE Oral Solid Within /Tablet Guidelines

02413361 LATUDA - 60 MG/TAB lurasidone hydrochloride N05AE Oral Solid Within /Tablet Guidelines

02387778 LATUDA - 80 MG/TAB lurasidone hydrochloride N05AE Oral Solid Within /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 124

PMPRB Annual Report 2017

02387786 LATUDA - lurasidone hydrochloride N05AE Oral Solid Within 120 MG/TAB /Tablet Guidelines

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 Does Not 750 MG/TAB /Modified Trigger release tablets

02309289 NIASPAN FCT - niacin C10AD Oral Solid Does Not 1000 MG/TAB /Modified Trigger release tablets

Swedish Orphan Biovitrum, SOBI AB

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02245913 KINERET - anakinra L04AA Parenteral Within 100 MG/SYRINGE /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 125

PMPRB Annual Report 2017

Takeda Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02242572 ACTOS - 15 MG/TAB pioglitazone A10BG Oral Solid Does Not hydrochloride /Tablet Trigger

02242573 ACTOS - 30 MG/TAB pioglitazone A10BG Oral Solid Does Not hydrochloride /Tablet Trigger

02242574 ACTOS - 45 MG/TAB pioglitazone A10BG Oral Solid Does Not hydrochloride /Tablet Trigger

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 Expired Within 300 MG/VIAL /Powder for Guidelines solution

02417235 KAZANO 12.5/1000 alogliptin A10BD Oral Solid Within benzoate/metformin /Tablet Guidelines hydrochloride

02417219 KAZANO 12.5/500 alogliptin A10BD Oral Solid Within benzoate/metformin /Tablet Guidelines hydrochloride

02417227 KAZANO 12.5/850 alogliptin A10BD Oral Solid Does Not benzoate/metformin /Tablet Trigger hydrochloride

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 126

PMPRB Annual Report 2017

02417200 NESINA - alogliptin benzoate A10BH Oral Solid Within 25 MG/TAB /Tablet Guidelines

02456796 NINLARO - ixazomib citrate L01XX Oral Solid Within 2.3 MG/CAPSULE /Capsule Guidelines

02456818 NINLARO - ixazomib citrate L01XX Oral Solid Within 3 MG/CAPSULE /Capsule Guidelines

02456826 NINLARO - ixazomib citrate L01XX Oral Solid Within 4 MG/CAPSULE /Capsule Guidelines

02239616 PANTO IV - pantoprazole sodium A02BC Parenteral Within 40 MG/VIAL /Powder for Guidelines solution

02241804 PANTOLOC - pantoprazole sodium A02BC Oral Solid Does Not 20 MG/TAB /Tablet Trigger

02229453 PANTOLOC - pantoprazole sodium A02BC Oral Solid Within 40 MG/TAB /Tablet Guidelines

02267233 TECTA - 40 MG/TAB pantoprazole magnesium A02BC Oral Solid Subj. /Tablet Investigation

02357380 ULORIC - 80 MG/TAB febuxostat M04AA Oral Solid Within /Tablet Guidelines

Teva Canada Innovation G.P.-S.E.N.C.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02245619 COPAXONE - glatiramer acetate L03AX Parenteral Within 20 MG/SYRINGE /Solution Guidelines

02456915 COPAXONE - glatiramer acetate L03AX Parenteral Within 40 MG/MILLILITER /Solution Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 127

PMPRB Annual Report 2017

02408007 FENTORA - fentanyl citrate N02AB Dental - Within 100 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02408015 FENTORA - fentanyl citrate N02AB Dental - Does Not 200 MCG/TAB Sublingual Trigger Buccal /Sublingual tablets

02408023 FENTORA - fentanyl citrate N02AB Dental - Within 400 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02408031 FENTORA - fentanyl citrate N02AB Dental - Within 600 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02408058 FENTORA - fentanyl citrate N02AB Dental - Within 800 MCG/TAB Sublingual Guidelines Buccal /Sublingual tablets

02257084 FROVA - 2.5 MG/TAB frovatriptan succinate N02CC Oral Solid Subj. /Tablet Investigation

Theratechnologies Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02438712 EGRIFTA - 1 MG/VIAL tesamorelin H01AC Parenteral Within /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 128

PMPRB Annual Report 2017

Tribute Pharmaceuticals Canada Ltd.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02454130 BLEXTEN - bilastine R06AX Oral Solid Introduced Does Not 20 MG/TAB /Tablet Trigger

02381680 CAMBIA - diclofenac potassium M01AB Oral Liquid Within 50 MG/POUCH /Powder for Guidelines solution

UCB Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02452936 BRIVLERA - brivaracetam N03AX Oral Solid Within 10 MG/TAB /Tablet Guidelines

02452944 BRIVLERA - brivaracetam N03AX Oral Solid Within 25 MG/TAB /Tablet Guidelines

02452952 BRIVLERA - brivaracetam N03AX Oral Solid Within 50 MG/TAB /Tablet Guidelines

02452960 BRIVLERA - brivaracetam N03AX Oral Solid Within 75 MG/TAB /Tablet Guidelines

02452979 BRIVLERA - brivaracetam N03AX Oral Solid Within 100 MG/TAB /Tablet Guidelines

02465574 CIMZIA - certolizumab pegol L04AB Parenteral Introduced Under Review 200 MG/MILLILITER /Powder for solution

02331675 CIMZIA - certolizumab pegol L04AB Parenteral Within 200 MG/MILLILITER /Powder for Guidelines solution

Patented Medicines for Human Use Reported to the PMPRB in 2017 129

PMPRB Annual Report 2017

02247027 KEPPRA - levetiracetam N03AX Oral Solid Does Not 250 MG/TAB /Tablet Trigger

02247028 KEPPRA - levetiracetam N03AX Oral Solid Subj. 500 MG/TAB /Tablet Investigation

02247029 KEPPRA - levetiracetam N03AX Oral Solid Subj. 750 MG/TAB /Tablet Investigation

02403897 NEUPRO - rotigotine N04BC Topical Within 1 MG/PATCH /Patches Guidelines

02403900 NEUPRO - rotigotine N04BC Topical Within 2 MG/PATCH /Patches Guidelines

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 - 50 MG/TAB lacosamide N03AX Oral Solid Does Not /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

Patented Medicines for Human Use Reported to the PMPRB in 2017 130

PMPRB Annual Report 2017

02357666 VIMPAT - lacosamide N03AX Parenteral Within 10 MG/MILLILITER /Solution Guidelines

Valeant Canada LP

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02281074 ACZONE - dapsone D10AX Topical /Gel Does Not 50 MG/GRAM Trigger

02456532 BEPREVE - bepotastine besilate S01 Ophthalmic Introduced/Expired Within 15 MG/ /Powder for Guidelines MILLILITER solution

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 Within 80 MG/TAB /Tablet Guidelines

02397749 EDARBYCLOR azilsartan C09DA Oral Solid Does Not 40/12.5 medoxomil/chlorthalidone /Tablet Trigger

02397765 EDARBYCLOR azilsartan C09DA Oral Solid Does Not 40/25 medoxomil/chlorthalidone /Tablet Trigger

02247238 ELIDEL - pimecrolimus D11AX Topical Within 10 MG/GRAM /Cream Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 131

PMPRB Annual Report 2017

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 Does Not 100 MG/GRAM /Liquid Trigger

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

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

Patented Medicines for Human Use Reported to the PMPRB in 2017 132

PMPRB Annual Report 2017

02306980 RETISERT - fluocinolone acetonide S01BA Ophthalmic Does Not 0.59 MG/ /Modified Trigger IMPLANT 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

TESTRED - methyltestosterone G03BA Oral Solid Does Not 10 MG/CAPSULE /Capsule Trigger

02256738 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Within 120 MG/TAB /Modified Guidelines release tablets

02256746 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Within 180 MG/TAB /Modified Guidelines release tablets

02256754 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Within 240 MG/TAB /Modified Guidelines release tablets

02256762 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Within 300 MG/TAB /Modified Guidelines release tablets

Patented Medicines for Human Use Reported to the PMPRB in 2017 133

PMPRB Annual Report 2017

02256770 TIAZAC XC - diltiazem hydrochloride C08DB Oral Solid Within 360 MG/TAB /Modified Guidelines release tablets

02365561 VYLOMA - imiquimod D06BB Topical Does Not 3 MG/POUCH /Cream Trigger

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/ /Solution Guidelines MILLILITER

02340445 ZYCLARA - imiquimod D06BB Topical Does Not 250 MG/POUCH /Cream Trigger

Valneva Austria GMBH

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02333279 IXIARO - japanese encephalitis J07BA Parenteral Within 6 MCG/DOSE vaccine (inactivated, /Suspensions Guidelines adsorbed) or Emulsions

Patented Medicines for Human Use Reported to the PMPRB in 2017 134

PMPRB Annual Report 2017

Vertex Pharmaceuticals Canada Inc.

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

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

02397412 KALYDECO - ivacaftor R07AX Oral Solid Within 150 MG/TAB /Tablet Guidelines

02463040 ORKAMBI 125/100 lumacaftor/ivacaftor R07AX Oral Solid Introduced Under Review /Tablet

02451379 ORKAMBI 200/125 lumacaftor/ivacaftor R07AX Oral Solid Subj. /Tablet Investigation

VIIV Healthcare ULC

DIN Brand Name Medicinal Ingredient ATC Dosage Comments Status

02192691 3TC - lamivudine J05AF Oral Liquid Does Not 10 MG/MILLILITER /Solution Trigger

02192683 3TC - 150 MG/TAB lamivudine J05AF Oral Solid Does Not /Tablet Trigger

02247825 3TC - 300 MG/TAB lamivudine J05AF Oral Solid Does Not /Tablet Trigger

02299844 CELSENTRI - maraviroc J05AX Oral Solid Does Not 150 MG/TAB /Tablet Trigger

Patented Medicines for Human Use Reported to the PMPRB in 2017 135

PMPRB Annual Report 2017

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 Subj. sulfate/lamivudine /Tablet Investigation

02238348 RESCRIPTOR - delavirdine mesylate J05AG Oral Solid Does Not 100 MG/TAB /Tablet Trigger

02261553 TELZIR - fosamprenavir calcium J05AE Oral Liquid Does Not 50 MG/MILLILITER /Suspension Trigger

02261545 TELZIR - 700 MG/TAB fosamprenavir calcium J05AE Oral Solid Within /Tablet Guidelines

02461218 TIVICAY - 10 MG/TAB dolutegravir J05AX Oral Solid Introduced Within /Tablet Guidelines

02461226 TIVICAY - 25 MG/TAB dolutegravir J05AX Oral Solid Introduced Within /Tablet Guidelines

02414945 TIVICAY - 50 MG/TAB dolutegravir J05AX Oral Solid Within /Tablet Guidelines

02430932 TRIUMEQ dolutegravir/abacavir/ J05AR Oral Solid Within 50/600/300 lamivudine /Tablet Guidelines

02244757 TRIZIVIR abacavir J05AF Oral Solid Within 150/300/300 sulfate/lamivudine/ /Tablet Guidelines zidovudine

02240358 ZIAGEN - abacavir sulfate J05AF Oral Liquid Does Not 20 MG/MILLILITER /Solution Trigger

02240357 ZIAGEN - abacavir sulfate J05AF Oral Solid Within 300 MG/TAB /Tablet Guidelines

Patented Medicines for Human Use Reported to the PMPRB in 2017 136