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Drug Insights > September 2015 Drug Pipeline Update
→ New Drug Information → Generic Drug Information
●● Synjardy™ (empagliflozin and metformin): Boehringer ●● Xenazine® (tetrabenazine): Two manufacturers have Ingelheim received Food and Drug Administration (FDA) launched their generic version of Lundbeck’s Xenazine approval for combination type 2 diabetes drug, Synjardy. for the treatment of chorea associated with Huntington’s The orally administered drug is a combination of the disease. SGLT2-inhibitor Jardiance® and metformin. ●● Naprelan® SR (naproxen SR 24hr): Generic versions of ●● Varubi™ (rolapitant): Tesaro obtained FDA approval for Almatica and Shionogi Pharma’s Naprelan SR for the Varubi to be used in combination with other drugs to treatment of pain and other conditions are now prevent and treat nausea and vomiting associated with available. According to IMS, Naprelan had approximately chemotherapy. Varubi’s mechanism of action is similar $58 million in annual U.S. sales. to Merck’s Emend®. ●● Atralin® (tretinoin gel, 0.05%): Spear Dermatology ●● Durlaza™ (aspirin, extended-release): New Haven Product has launched their generic equivalent of Pharmaceuticals received FDA approval for their Valeant’s Atralin for topical treatment of acne vulgaris. 162.5 mg strength of aspirin for the secondary ●● Exelon® TD patch (rivastigmine TD patch): Sandoz has prevention of stroke and acute cardiac events such as launched their generic version of Novartis’ Exelon patch myocardial infarction in high-risk patients. Durlaza will for the treatment of Alzheimer’s disease. According to be available by prescription only. IMS, Exelon had approximately $626 million in annual ●● Vraylar™ (cariprazine): The FDA has approved Allergan’s U.S. sales. Vraylar for the treatment of adults with bipolar and schizophrenia. The FDA had previously rejected the application asking for more data.
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* 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 June 2015 with diarrhea ivabradine Corlanor® Amgen Heart failure April 2015
isavuconazonium Cresemba™ Astellas Broad-spectrum azole antifungal March 2015
ceftazidine/avibactam Avycaz™ Actavis/AstraZeneca Bacterial infection February 2015
edoxaban Savaysa™ Daiichi Sankyo Anticoagulant January 2015
ceftolozane/tazobactam Zerbaxa™ Cubist Bacterial infection December 2014
peramivir Rapivab™ BioCryst Pharmaceuticals Viral infection December 2014
finafloxacin otic suspension Xtoro™ Alcon Acute otitis externa December 2014
palonosetron/netupitant Akynzeo™ Eisai Nausea and vomiting October 2014
*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* 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™ Respimat® Boehringer Ingelheim COPD May 2015 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 Contraception (intrauterine) 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 enteral Duopa™ AbbVie Parkinson’s disease January 2015 suspension carbidopa/levodopa extended Rytary™ Impax Laboratories Parkinson’s disease January 2015 release ivermectin cream 1% Soolontra™ Galderma Rosacea January 2015 memantine extended release/ Namzaric™ Forest Alzheimer’s disease January 2015 donepezil liraglutide 3 mg Saxenda® Novo Nordisk Obesity December 2014 hydrocodone ER Hysingla™ ER Purdue Pain November 2014 dapagliflozin/metformin Xigduo™ XR AstraZeneca Diabetes November 2014 budesonide foam Uceris® Salix Ulcerative colitis October 2014
*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 codeine/chlorpheniramine Rinotuss™ 12 Spriaso/NexGen Cough and cold relief Summer 2015
saxagliptin/dapagliflozin N/A AstraZeneca Diabetes 4Q 2015
morphine ER MorphaBond™ ER Inspirion Delivery Pain (abuse deterrent) September 2015
aripiprazole lauroxil Aristada™ Alkermes Schizophrenia October 2015
oxycodone, extended-release Xtampeza™ Collegium Pharmaceuticals Pain (abuse deterrent) October 2015
hydrocodone ER N/A Teva Pain (abuse deterrent) October 2015
oxycodone IR Avridi™ Purdue Pain (abuse deterrent) October 2015
buprenorphine buccal film Belbuca™ Endo, Biodelivery Sciences Pain October 2015
oxycodone/naltrexone ER N/A Pfizer Pain (abuse deterrent) October 2015
amphetamine Dynavel™ XR Tris Pharma ADHD October 2015
insulin degludec/insulin aspart Ryzodeg™ NovoNordisk Diabetes October 2015
insulin degludec Tresiba™ NovoNordisk Diabetes October 2015
patiromer N/A Relypsa High potassium October 2015
lifitegrast N/A Shire Dry eye disease October 2015
brivaracetam N/A UCB Pharma Seizures November 2015
meloxicam N/A Iroko Pain November 2015
sumatriptan, intranasal powder N/A Avanir Migraine November 2015
methylphenidate ER, ODT Cotempla™ Neos Therapeutics ADHD November 2015 XR-ODT calcipotriene/betamethasone, N/A Leo Pharma Plaque psoriasis November 2015 aerosol foam naloxone nasal spray N/A Indivior, AntiOp Treatment of opioid overdose November 2015
enclomiphene N/A Repros Low testosterone November 2015
glycopyrronium N/A Novartis COPD December 2015
glycopyrronium/indacaterol N/A Novartis COPD December 2015
lesinurad N/A AstraZeneca Gout December 2015
safinamide Xadago™ Newron Pharmaceuticals Parkinson’s disease December 2015 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* 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 (PPI) February 2015
celecoxib Celebrex® Pfizer Pain December 2014
valganciclovir Valcyte® Genentech Viral infections November 2014
*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* 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 Shionogi Pain September 2015 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 August 2015
acetaminophen/caffeine/dihydrocodeine Trezix® Wraser Pharmaceuticals Pain August 2015
megestrol acetate suspension Megace® ES Par Loss of appetite August 2015
budesonide inhalation susp, 1 mg/2 mL Pulmicort® Respules AstraZeneca Respiratory August 2015
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 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
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 Contraception (oral) 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
guanfacine Intuniv® Shire ADHD December 2014
urea cream Keralac® Brava Pharmaceuticals Dry skin conditions December 2014
sulfacetamide sodium/sulfur liquid, Plexion® Brava Pharmaceuticals Acne December 2014 cream and lotion tacrolimus ointment Protopic® Astellas Atopic dermatitis December 2014
sirolimus Rapamune® Pfizer Prevention of transplant November 2014 rejection ivermectin Stromectol® Merck Parasitic roundworm November 2014 infections norethindrone/ethinyl estradiol/FE Loestrin® 24 FE Actavis Contraception (oral) November 2014 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* olopatadine nasal solution Patanase® Alcon Allergic rhinitis November 2014
mycophenolate Cellcept® suspension Genentech Prevention of transplant November 2014 rejection amlodipine, valsartan Exforge® Novartis High blood pressure October 2014
*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* aprepitant Emend® Merck Nausea and vomiting 4Q 2015
dutasteride Avodart® GlaxoSmithKline Benign prostatic hyperplasia 4Q 2015 (BPH) palonosetron Aloxi® (capsule) Eisai Nausea and vomiting October 2015
*Expected to market dates are predictions made by Prime Therapeutics based on industry information.
2992-A1 © Prime Therapeutics LLC 09/15