Drug Pipeline Update
D Drug Insights > March 2016
→ New drug information → Generic drug information
●● Briviact® (brivaracetam): UCB received Food and ●● Oxistat® cream (oxiconazole cream, 1%): There is now a Drug Administration (FDA) approval for their new generic version of Pharmaderm’s Oxistat cream for the anticonvulsant. Briviact is approved as an adjunctive topical treatment of fungal infections. therapy for the treatment of partial-onset seizures ●● Cyclogyl 0.5%® (cyclopentolate ophthalmic solution, in epilepsy patients over 16 years of age. It is similar 0.5%): Alcon’s Cyclogyl, used to produce mydriasis and in mechanism of action to Keppra® (levetiracetam) cycloplegia, is now available generically. and generics.
While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Drug Pipeline > March 2016 Page 2
New molecular entity approvals in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* brivaracetam Briviact® UCB Seizure February 2016
glycopyrronium Seebri™ Neohaler Novartis COPD November 2015
glycopyrronium/indacaterol Utibron™ Neohaler Novartis COPD November 2015
patiromer Veltassa™ Relypsa High potassium October 2015
insulin degludec/insulin aspart Ryzodeg™ Novo Nordisk Diabetes October 2015
insulin degludec Tresiba™ Novo Nordisk Diabetes October 2015
cariprazine Vraylar™ Allergan Bipolar and schizophrenia September 2015
rolapitant Varubi™ Tesaro Prevention and treatment of September 2015 chemotherapy induced nausea and vomiting flibanserin Addyi™ Sprout Pharmaceuticals Hypoactive sexual desire disorder August 2015 (women) sacubitril/valsartan Entresto™ Novartis Heart failure July 2015
brexpiprazole Rexulti™ Otsuka/Lundbeck Schizophrenia/depression July 2015
eluxadoline Viberzi™ Actavis IBS-D June 2015
ivabradine Corlanor® Amgen Heart failure April 2015
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline > March 2016 Page 3
Other new product approvals in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* sumatriptan succinate injection Zembrace™ Dr. Reddy’s Migraine February 2016 SymTouch™ sumatriptan, intranasal powder Onzetra™ Xsail™ Avanir and Optinose Migraine February 2016
lesinurad Zurampic™ AstraZeneca Gout January 2016
amphetamine extended-release ODT Adzenys XR-ODT™ Neos Therapeutics ADHD January 2016
insulin human injection Humulin® R Lilly Diabetes January 2016 U-500 KwikPen methylphenidate extended-release QuilliChew™ ER Pfizer ADHD December 2015
insulin glargine Basaglar™ Lilly Diabetes December 2015
naloxone Narcan® Adapt Pharma/ Opioid overdose November 2015 Lightlake Therapeutics calcipotriene/betamethasone, Enstilar® Leo Pharma Plaque psoriasis November 2015 aerosol foam meloxicam Vivlodex™ Iroko Pain October 2015
amphetamine Dynavel™ XR Tris Pharma ADHD October 2015
buprenorphine buccal film Belbuca™ Endo, Biodelivery Sciences Pain October 2015
aripiprazole lauroxil Aristada™ Alkermes Schizophrenia October 2015
morphine ER MorphaBond™ ER Inspirion Delivery Diabetes November 2014
aspirin, extended-release Durlaza™ New Haven Pharmaceuticals Cardiovascular prevention September 2015
empagliflozin and metformin Synjardy™ Boehringer Ingelheim Diabetes August 2015
levetiracetam Spritam™ Aprecia Seizures August 2015
tacrolimus Envarsus® XR Veloxis Pharma Prophylaxis of rejection in July 2015 kidney transplant doxycycline hyclate Targadox™ Journey Medical Corporation Treatment of various infections June 2015
duloxetine 40 mg Irenka™ Lupin Pharmaceuticals Major depressive disorder, June 2015 generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain olodaterol/tiotropium Stiolto™ Boehringer Ingelheim COPD May 2015 Respimat® paliperidone palmitate Invega Trinza™ Johnson & Johnson Schizophrenia May 2015
codeine/chlorpheniramine Tuzistra™ XR Tris Pharma/Vernalis Cough and cold relief May 2015
albuterol Proair® RespiClick Teva Asthma April 2015
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline > March 2016 Page 4
Pipeline watch Anticipated FDA Generic name Brand name Manufacturer Indication(s) decision date gepirone ER n/a Fabre-Kramer Depression 1Q2016 Pharmaceuticals granisetron, extended-release Sustol™ Heron Therapeutics Nausea/vomiting 1st half 2016
safinamide Xadago™ Newron Pharmaceuticals Parkinson’s disease March 2016
calcifediol Rayaldee Opko Health Chronic kidney disease and March 2016 vitamin D insufficiency glycopyrrolate/formoterol n/a AstraZeneca COPD 2Q2016
aripiprazole, digital tablet Abilify® Otsuka/Proteus Health Schizophrenia, bipolar disorder April 2016 and major depression dronabinol oral solution n/a Insys Therapeutics Cachexia April 2016
bromfenac 0.075% BromSite™ InSite Vision Inflammation and pain associated April 2016 with cataract surgery methylnaltrexone Relistor® Valeant Opioid-induced constipation April 2016
pimavanserin Nuplazid™ Acadia Psychosis associated with April 2016 Parkinson's disease arbaclofen, extended-release Ontinua™ ER Osmotica Spasticity associated with May 2016 multiple sclerosis sodium zirconium cyclosilicate N/A ZS Pharma Treatment of hyperkalemia May 2016
buprenorphine implant Probuphine™ Braeburn and Titan Maintenance treatment of May 2016 opioid dependence epinephrine N/A Adamis Pharmaceuticals Treatment of allergic reactions June 2016 (anaphylaxis) benzyhydrocodone/acetaminophen N/A KemPharm Treatment of acute pain June 2016 (immediate release) lixisenatide/insulin glargine LixiLan™ Sanofi Diabetes June 2016
testosterone N/A Lipocine Replacement therapy June 2016 Drug Pipeline > March 2016 Page 5
First generic approvals of top selling brand name drugs in the past twelve months
Generic name Brand name Brand manufacturer Indication(s) Date approved* imatinib Gleevec® Novartis Cancer (multiple indications) February 2016
dutasteride Avodart® GlaxoSmithKline BPH October 2015
memantine Namenda® Actavis Alzheimer’s disease July 2015
glatiramer Glatopa™ Teva Relapsing-remitting June 2015 multiple sclerosis aripiprazole Abilify® Bristol-Myers Squibb Schizophrenia, bipolar disorder May 2015 and Tourette’s syndrome *Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. Drug Pipeline > March 2016 Page 6
Other first generic approvals in the past twelve months Generic name Brand name Brand manufacturer Indication(s) Date approved* oxiconazole cream, 1% Oxistat® cream Pharmaderm Fungal infection March 2016 cyclopentolate ophthalmic solution, 0.5% Cyclogyl® 0.5% Alcon To produce mydriasis March 2016 and cycloplegia naftifine cream, 2% Naftin® Merz Pharmaceuticals Fungal infection February 2016 metformin modified release 24hr SR Glumetza® Valeant Diabetes February 2016 norgestimate/ethinyl estradiol Ortho Tri-Cyclen Lo® Jannsen Oral contraceptive January 2016 linezolid suspension Zyvox® Pfizer Treatment of bacterial December 2015 infection repaglinide/metformin Prandimet™ NovoNordisk Diabetes December 2015 dutasteride/tamsulosin Jalyn® GlaxoSmithKline BPH December 2015 trimipramine Surmontil® Teva Antidepressant November 2015 nevirapine ER Viramune® XR Boehringer Ingelheim HIV November 2015 paliperidone ER Invega® Janssen Schizophrenia October 2015 fluvastatin Lescol® XL Novartis High cholesterol October 2015 testosterone transdermal gel, 1% Androgel® AbbVie Low testosterone October 2015 pimozide Orap® Teva Tourette’s syndrome October 2015 methyltestosterone Testred® and Android® Valeant Hormone replacement October 2015 memantine oral solution Namenda® Actavis Alzheimer’s disease October 2015 rivastigmine TD patch Exelon® TD patch Novartis Alzheimer’s disease September 2015 tretinoin gel, 0.05% Atralin® Valeant Acne September 2015 naproxen SR 24hr Naprelan® SR Almatica and Pain September 2015 Shionogi Pharma tetrabenazine Xenazine® Lundbeck Chorea associated with August 2015 Huntington’s disease pramipexole extended-release Mirapex® Boehringer Ingelheim Parkinson’s disease August 2015 phenoxybenzamine Dibenzyline® Concordia Pheochromocytoma August2015 acetaminophen/caffeine/dihydrocodeine Trezix® Wraser Pharmaceuticals Pain August2015 megestrol acetate suspension Megace® ES Par For the treatment of August2015 appetite loss budesonide inhalation susp, 1 mg/2 mL Pulmicort® Respules AstraZeneca Respiratory August2015 almotriptan Axert® Jannsen Migraine July 2015 pyridostigmine bromide Mestinon® Timespan Valeant Myasthenia gravis July 2015 bexarotene Targretin® Valeant Cutaneous t-cell lymphoma July 2015 alosetron Lotronex® Prometheus IBS-D June 2015 naftifine cream, 1% Naftin® Merz Fungal infections (topical) June 2015 risedronate Actonel® Actavis Osteoporosis June 2015 norethindrone/ethinyl estradiol Femhrt® Actavis Menopause symptoms May 2015 tolcapone Tasmar® Valeant’ Parkinson’s disease May 2015 benzonatate Zonatuss® Vertical Relief of cough May 2015 metoclopramide ODT Metozolv® ODT Salix Relief of GERD April 2015 norethindrone/ethinyl estradiol/FE Generess FE® Warner Chilcott Oral contraceptive April 2015
*Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. Drug Pipeline > March 2016 Page 7
Generics of top selling brand drugs potentially available soon
Generic name Brand name Brand manufacturer Indication(s) To market date* rosuvastatin Crestor® AstraZeneca High cholesterol May 2016
olmesartan and olmesartan/HCTZ Benicar®/ Daiichi-Sankyo High blood pressure October 2016 Benicar® HCT *Expected launch dates are predictions made by Prime Therapeutics based on industry information. 03002301
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