CLINICAL SOLUTIONS
Drug Insights > December 2015 Drug Pipeline Update
→ New Drug Information → Generic Drug Information
Narcan® (naloxone): Adapt Pharma and Lightlake Zyvox® (linezolid suspension): There is now a generic Therapeutics received Food and Drug Administration version of Pfizer’s Zyvox for the treatment of different (FDA) approval for their nasally administered naloxone types of bacterial infections. for administration by non-medically trained personnel Jalyn® (dutasteride/tamsulosin): GlaxoSmithKline’s for treatment of opioid overdose. Jalyn, a treatment for benign prostatic hyperplasia Basaglar™ (insulin glargine): The FDA approved Lilly’s (BPH), is now available generically. Basaglar, basal insulin, for the treatment of diabetes. Prandimet™ (repaglinide/metformin): A generic version Because of a settlement agreement, the drug is not of NovoNordisk’s combination diabetes drug, Prandimet, anticipated to launch until December 2016. is now available. QuilliChew™ ER (methylphenidate extended-release): Pfizer received approval for their long-acting, chewable formulation of methylphenidate for the treatment of attention deficit-hyperactivity disorder (ADHD) in patients 6 and older.
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 Insights > Drug Pipeline Update Page 2
New Molecular Entity Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s) Date Approved* glycopyrronium Seebri™ Novartis COPD November 2015 Neohaler glycopyrronium/indacaterol Utibron™ Novartis COPD November 2015 Neohaler 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 Irritable bowel syndrome with June 2015 diarrhea ivabradine Corlanor® Amgen Heart failure April 2015
isavuconazonium Cresemba™ Astellas Broad-spectrum azole antifungal March 2015
ceftazidine/avibactam Avycaz™ Actavis/AstraZeneca Antibiotic February 2015
edoxaban Savaysa™ Daiichi Sankyo Anticoagulant January 2015
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Insights > Drug Pipeline Update Page 3
Other New Product Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s) Date Approved* 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 Pain (abuse deterrent) October 2015 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 kidney July 2015 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 levetiracetam extended-release Elepsia™ XR Sun Pharmaceuticals Seizures March 2015 tablets levonorgestrel Liletta™ Actavis/Medicines 360 Intrauterine contraceptive February 2015 insulin U-300 Toujeo™ Sanofi Diabetes February 2015 olopatadine ophthalmic solution Pazeo™ Alcon Ocular allergies February 2015 empagliflozin/linagliptin Glyxambi™ Boehringer Ingelheim/ Diabetes January 2015 Eli Lilly hydrocodone ER Zohydro™ ER Zogenix Pain January 2015 perindopril and amlodpine Prestalia™ Symplmed Pharmaceuticals High blood pressure January 2015 carbidopa/levodopa Duopa™ AbbVie Parkinson’s disease January 2015 enteral suspension carbidopa/levodopa Rytary™ Impax Laboratories Parkinson’s disease January 2015 extended release ivermectin cream 1% Soolontra™ Galderma Rosacea January 2015 memantine extended release/ Namzaric™ Forest Alzheimer’s disease January 2015 donepezil *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Insights > Drug Pipeline Update Page 4
Pipeline Watch Anticipated FDA Generic Name Brand Name Manufacturer Indication(s) Decision Date lesinurad N/A AstraZeneca Gout December 2015
gepirone ER N/A Fabre-Kramer Depression 1Q2016 Pharmaceuticals oxycodone/naltrexone, N/A Pfizer Pain January 2016 extended release granisetron, extended release Sustol™ Heron Therapeutics Nausea/vomiting January 2016
amphetamine, extended release, NA Neos Therapeutics ADHD January 2016 orally disintegrating buprenorphine implant Probuphine™ Braeburn and Titan Maintenance treatment of February 2016 opioid dependence safinamide Xadago™ Newron Pharmaceuticals Parkinson’s disease March 2016
calcifediol Rayaldee Opko Health Chronic kidney disease and March 2016 vitamin D insufficiency aripiprazole, digital tablet Abilify® Otsuka/Proteus Health Schizophrenia, bipolar disorder April 2016 and major depression dronabinol oral solution NA 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 Drug Insights > Drug Pipeline Update 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* dutasteride Avodart® GlaxoSmithKline BPH October 2015
memantine Namenda® Actavis Alzheimer’s disease July 2015
glatiramer Glatopa™ Teva Relapsing-remitting multiple June 2015 sclerosis aripiprazole Abilify® Bristol-Myers Squibb Schizophrenia, bipolar disorder May 2015 and Tourette’s syndrome esomeprazole Nexium® AstraZeneca Gastrointestinal disorders February 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 Insights > Drug Pipeline Update Page 6
Other First Generic Approvals in the Past Twelve Months
Generic Name Brand Name Brand Manufacturer Indication(s) Date Approved* 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 disorder October 2015
methyltestosterone Testred® and Valeant Hormone replacement October 2015 Android® 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/ Trezix® Wraser Pharmaceuticals Pain August2015 dihydrocodeine megestrol acetate suspension Megace® ES Par Los of appetite August2015
budesonide inhalation susp, Pulmicort® AstraZeneca Respiratory August2015 1 mg/2 mL Respules almotriptan Axert® Jannsen Migraine July 2015
pyridostigmine bromide Mestinon® Valeant Myasthenia gravis July 2015 Timespan bexarotene Targretin® Valeant Cutaneous T-cell lymphoma July 2015
alosetron Lotronex® Prometheus Irritable bowel syndrome June 2015 with diarrhea 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
Continued → Drug Insights > Drug Pipeline Update Page 7
Other First Generic Approvals in the Past Twelve Months (Continued)
Generic Name Brand Name Brand Manufacturer Indication(s) Date Approved* benzonatate Zonatuss® Vertical Cough relief May 2015
metoclopramide ODT Metozolv® ODT Salix Gastroesophageal reflux April 2015 disease norethindrone/ethinyl estradiol/FE Generess FE® Warner Chilcott Oral contraceptive April 2015
naproxen sustained-release Naprelan® Almatica Pain March 2015
methylphenidate chewable tabs Methylin® Shionogi Pharma ADHD March 2015
pramipexole Mirapex® ER Boehringer Ingelheim Parkinson’s disease February 2015
clobetasol spray, 0.05% Clobex® spray Galderma Psoriasis January 2015
estradiol TD patch Vivelle® Dot Novartis Vasomotor symptoms January 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.
Generics of Top Selling Brand Drugs Potentially Available Soon
Generic Name Brand Name Brand Manufacturer Indication(s) To Market Date* imatinib Gleevec® Novartis Cancer (multiple indications) February 2016
rosuvastatin Crestor® AstraZeneca High cholesterol May 2016
olmesartan and olmesartan/HCTZ Benicar®/ Daiichi-Sankyo High blood pressure October 2016 Benicar® HCT *Expected to market dates are predictions made by Prime Therapeutics based on industry information. 03001858
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