CLINICAL SOLUTIONS Drug Insights > September 2015 Drug Pipeline Update New Drug Information Synjardy (empagliflozin and metformin): Boehringer Ingelheim received Food and Drug Administration (FDA) approval for combination type 2 diabetes drug, Synjardy. The orally administered drug is a combination of the SGLT2-inhibitor Jardiance and metformin. Varubi (rolapitant): Tesaro obtained FDA approval for Varubi to be used in combination with other drugs to prevent and treat nausea and vomiting associated with chemotherapy. Varubi s mechanism of action is similar to Merck s Emend. Durlaza (aspirin, extended-release): New Haven Pharmaceuticals received FDA approval for their 162.5 mg strength of aspirin for the secondary prevention of stroke and acute cardiac events such as myocardial infarction in high-risk patients. Durlaza will be available by prescription only. Vraylar (cariprazine): The FDA has approved Allergan s Vraylar for the treatment of adults with bipolar and schizophrenia. The FDA had previously rejected the application asking for more data. Generic Drug Information Xenazine (tetrabenazine): Two manufacturers have launched their generic version of Lundbeck s Xenazine for the treatment of chorea associated with Huntington s disease. Naprelan SR (naproxen SR 24hr): Generic versions of Almatica and Shionogi Pharma s Naprelan SR for the treatment of pain and other conditions are now available. According to IMS, Naprelan had approximately $58 million in annual U.S. sales. Atralin (tretinoin gel, 0.05%): Spear Dermatology Product has launched their generic equivalent of Valeant s Atralin for topical treatment of acne vulgaris. Exelon TD patch (rivastigmine TD patch): Sandoz has launched their generic version of Novartis Exelon patch for the treatment of Alzheimer s disease. According to IMS, Exelon had approximately $626 million in annual U.S. sales. 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 chemotherapy induced nausea and vomiting flibanserin Addyi Sprout Pharmaceuticals Hypoactive sexual desire disorder (women) September 2015 August 2015 sacubitril/valsartan Entresto Novartis Heart failure July 2015 brexpiprazole Rexulti Otsuka/Lundbeck Schizophrenia/depression July 2015 eluxadoline Viberzi Actavis Irritable bowel syndrome 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 transplant July 2015 doxycycline hyclate Targadox Journey Medical Corporation Treatment of various infections duloxetine 40 mg Irenka Lupin Pharmaceuticals Major depressive disorder, 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 tablets Elepsia XR Sun Pharmaceuticals Seizures March 2015 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/ Eli Lilly Diabetes January 2015 hydrocodone ER Zohydro ER Zogenix Pain January 2015 perindopril and amlodpine Prestalia Symplmed Pharmaceuticals High blood pressure January 2015 carbidopa/levodopa enteral suspension carbidopa/levodopa extended release Duopa AbbVie Parkinson s disease January 2015 Rytary Impax Laboratories Parkinson s disease January 2015 ivermectin cream 1% Soolontra Galderma Rosacea January 2015 memantine extended release/ donepezil Namzaric Forest Alzheimer s disease January 2015 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 Generic Name Brand Name Manufacturer Indication(s) Anticipated FDA 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 calcipotriene/betamethasone, aerosol foam Cotempla XR-ODT Neos Therapeutics ADHD November 2015 N/A Leo Pharma Plaque psoriasis November 2015 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 sclerosis aripiprazole Abilify Bristol-Myers Squibb Schizophrenia, bipolar disorder and Tourette s syndrome May 2015 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 Pharma tetrabenazine Xenazine Lundbeck Chorea associated with Huntington s disease Pain September 2015 August 2015 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 with diarrhea naftifine cream, 1% Naftin Merz Fungal infections (topical) risedronate Actonel Actavis Osteoporosis 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, cream and lotion Plexion Brava Pharmaceuticals Acne December 2014 tacrolimus ointment Protopic Astellas Atopic dermatitis December 2014 sirolimus Rapamune Pfizer Prevention of transplant rejection ivermectin Stromectol Merck Parasitic roundworm infections November 2014 November 2014 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 rejection November 2014 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 (BPH) 4Q 2015 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