Drug Pipeline Monthly Update Critical updates in an ever changing environment June 2017 New drug information Baxdela (delafloxacin): The Food and Drug Administration (FDA) approved Melinta s Baxdela, a fluoroquinolone antibiotic, for the treatment of skin and skin structure infections caused by a range of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Baxdela is available both as an intravenous infusion and as an oral tablet. Symjepi (epinephrine injection): The FDA approved Adamis Symjepi, a therapeutic alternative to Mylan s EpiPen. Symjepi is available as a prefilled syringe that can be administered via intramuscular or subcutaneous routes for the emergency treatment of allergic reaction, including anaphylaxis. It is not an alternative for EpiPen Jr, but Adamis does plan to file a New Drug Application (NDA) for a junior version in the future. Adamis anticipates launch of Symjepi in the second half of 2017 at a lower cost than EpiPen. 1 Generic drug information Armour Thyroid (thyroid tab): Acella launched the first generic for Actavis Armour Thyroid for the replacement or supplemental therapy in patients with hypothyroidism. Strattera (atomoxetine): Teva, Glenmark, and Aurobindo/Rising have launched their generic versions of Eli Lilly s Strattera for the treatment of attention-deficit/hyperactivity disorder (ADHD). According to IMS, Strattera had approximately $535 million in sales over the past year. Pataday (olopatadine): Teva has launched the first generic for Novartis Pataday for the treatment of ocular itching associated with allergic conjunctivitis. Teva has 180 days of marketing exclusivity after which multiple manufactures will launch their generic versions of Pataday. According to IMS, Pataday had $303 million dollars in sales over the past year. Acticlate (doxycycline hyclate): Mayne Pharma launched their generic of Aqua Acticlate for the treatment of: rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, alternative treatment to penicillin where it is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and the prevention of malaria. Apotex may receive FDA approval for their generic version in 2018 2019. Acticlate generated $250 million in U.S. annual sales over the past year. Renvela (sevelamer carbonate): Aurobindo Pharma launched their generic of Genzyme s Renvela packets for oral suspension to control serum phosphorus in patients with chronic kidney disease on dialysis. It is unclear when the FDA will grant approval to additional generic versions of Renvela packets. 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 Monthly Update: June 2017 Page 2 New molecular entity approvals in the past 12 months Generic name Brand name Manufacturer Indication(s) Date approved* delafloxacin Baxdela Melinta Skin infections June 2017 naldemedine Symproic Shionogi Pain March 2017 safinamide Xadago Newron Parkinson s disease March 2017 desmopressin nasal spray Noctiva Allergan and Serenity Nocturnal polyuria March 2017 house dust mite sublingual allergy immunotherapy Odactra Merck, Sharp & Dohme House dust mite allergies March 2017 plecanatide Trulance Synergy Chronic idiopathic constipation January 2017 crisaborole Eucrisa Pfizer/Anacor Mild to moderate atopic dermatitis December 2016 prasterone Intrarosa Endoceutics Inc Pain during intercourse November 2016 lixisenatide Adlyxin Sanofi Diabetes July 2016 lifitegrast Xiidra Shire Dry eye disease July 2016 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer.
Drug Pipeline Monthly Update: June 2017 Page 3 Other new product approvals in the past twelve months Generic name Brand name Manufacturer Indication(s) Date approved* epinephrine injection Symjepi Adamis Allergic reactions June 2017 Corporation methotrexate solution Xatmep Silvergate ALL and arthritis in pediatric patients April 2017 oxycodone, immediate-release RoxyBond Inspirion/Daiichi Pain with abuse-deterrent April 2017 Sankyo dapagliflozin/saxagliptin Qtern AstraZeneca Diabetes February 2016 lisdexamfetamine Vyvanse Shire ADHD (chew tab) February 2017 naloxone nasal spray, 2 mg Narcan Adapt Pharma Inc Opioid overdose January 2016 fluticasone propionate fluticasone propionate/ salmeterol ArmonAir Teva Asthma January 2016 RespiClick AirDuo RespiClick Teva Asthma January 2016 oxymetazoline Rhofade Allergan Rosacea January 2016 hydrocodone extended release Vantrela ER Teva Pain, abuse deterrent January 2016 morphine extended release Arymo ER Egalet Pain, abuse deterrent January 2016 insulin glargine Basaglar Eli Lilly Diabetes December 2015, launched in December 2016 empagliflozin/metformin Synjardy XR Eli Lilly Diabetes December 2016 extended release Lantus (insulin glargine)/ Soliqua Sanofi Diabetes November 2016 Adlyxin (lixisenatide) Tresiba (insulin degludec/ Xultophy Novo Nordisk Diabetes November 2016 Victoza (liraglutide) doxylamine/pyridoxine XR Bonjesta Duchesnay Pregnancy-related nausea and vomiting November 2016 tenofovir alafenamide Vemlidy Gilead Hepatitis B November 2016 mebendazole Vermox Johnson & Johnson/ Parasitic disease November 2016 Janssen norethindrone/estradiol fe Taytulla Apil Pregnancy prevention October 2016 sumatriptan/naproxen Treximet Permix Migraine October 2016 levonorgestrel-releasing Kyleena Bayer AG Pregnancy prevention September 2016 intrauterine system phentermine HCl Lomaira KVK Tech Weight loss September 2016 aspirin/omeprazole delayedrelease oxycodone/naltrexone extended release granisetron, extended-release injection Yosprala Aralez, Inc Secondary prevention of CV disease in patients with high risk for ASA-induced ulcers September 2016 Troxyca ER Pfizer Pain August 2016 Sustol Heron Therapeutics Prevention of chemotherapy-induced nausea and vomiting August 2016 lisinopril oral solution Qbrelis Silvergate Hypertension July 2016, Inc dronabinol Syndros Insys Therapeutics HIV wasting and chemotherapy induced nausea and vomiting in cancer patients July 2016 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer.
Drug Pipeline Monthly Update: June 2017 Page 4 Pipeline watch Generic name Brand name Manufacturer Indication(s) Anticipated FDA decision date ozenoxacin N/A Medimetriks Impetigo June 2017 methylphenidate ER Cotempla XR-ODT Neos Therapeutics ADHD June 2017 mixed amphetamine salts long acting betrixaban N/A Portola methylphenidate delayed and extended release N/A Shire ADHD June 2017 N/A Ironshore / Highland Therapeutics Prevention of venous thromboembolism June 2017 (VTE) ADHD July 2017 CCP-08 N/A Vernalis/ Cough and cold August 2017 Tris ITCA 650 (exenatide mini-pump) N/A Intarcia Diabetes September 2017 oxycodone controlled-release Rexista Intellipharmaceuticals Pain, abuse deterrent September 2017 fluticasone furoate/ N/A GSK/Innoviva COPD September 2017 umeclidinium/vilanterol secnidazole Solosec Symbiomix Bacterial vaginosis September 2017 amphetamine XR N/A Neos Therapeutics ADHD September 2017 lesinurad/allopurinol Duzallo Ironwood Uncontrolled gout September 2017 insulin aspart FIAsp Novo Nordisk Diabetes September 2017 cetirizine Zerviate NicOx Eye itching and inflammation September 2017 tadalafil PharmFilm N/A MonoSol RX ED September 2017 testosterone enanthate QuickShot Antares Hypogonadism October 2017 aprepitant Cinvanti Heron Therapeutics Chemotherapy-induced nausea and November 2017 vomiting semaglutide N/A Novo Nordisk Diabetes December 2017 ertugliflozin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/metformin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/sitagliptin N/A Merck/Pfizer Diabetes December 2017 acetaminophen/ibuprofen Maxigesic AFT Pain December 2017
Drug Pipeline Monthly Update: June 2017 Page 5 First generic approvals of top selling brand name drugs in the past twelve months Generic name Brand name Manufacturer Indication(s) Approval date* atomoxetine Strattera Eli Lilly ADHD June 2017 ezetimibe Noctiva Allergan and Serenity Nocturnal polyuria March 2017 simvastatin Vytorin Merck/ Schering-Plough High cholesterol May 2017 desvenlafaxine SR Pristiq Pfizer Depression March 2017 methylphenidate ER Concerta Janssen ADHD January 2017 oseltamivir phosphate capsules Tamiflu Roche/Genetech Influenza December 2016 ezetimibe Zetia Merck High cholesterol December 2016 olmesartan and olmesartan/hctz Benicar / Benicar HCT Daiichi-Sankyo High blood pressure November 2016 quetiapine XR Seroquel XR AstraZeneca Schizophrenia/bipolar disorder November 2016 * 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 Monthly Update: June 2017 Page 6 Other first generic launches in the past twelve months Generic name Brand name Manufacturer Indication(s) Date approved* olopatadine solution Pataday Teva Eye itching June 2017 thyroid tab Armour Thyroid Actavis Hypothyroid June 2017 desoximetasone ointment Topicort Taro Skin conditions May 2017 tazarotene cream Tazorac Allergan Plaque psoriasis and acne April 2017 levonorgestrel/ethinyl estradiol Quartette Teva Pregnancy prevention April 2017 venlafaxine extended-release Venlafaxine ER UCB Pharma/Vertical Depression and anxiety April 2017 zileuton extended-release Zyflo CR Chiesi USA Asthma April 2017 prednisolone sodium phosphate Millipred Zylera Inflammatory conditions March 2017 oral solution 10 mg/5 ml prednisolone sodium phosphate Veripred 20 Zylera Inflammatory conditions March 2017 oral solution 20 mg/5 ml methylphenidate SR 60 mg Ritalin LA Novartis ADHD March 2017 flurandrenolide oint Cordran Aqua Skin irritation February 2017 lopinavir/ritonavir soln Kaletra AbbVie HIV January 2017 aspirin/dipyridamole Aggrenox Boehringer Ingelheim Reduce risk of stroke January 2017 dexmethylphenidate Focalin XR Novartis ADHD January 2017 rasagiline Azilect Teva Neuroscience Parkinson s disease January 2017 aprepitant Emend Merck/Schering-Plough Chemotherapy induced nausea/ vomiting epinephrine injection, USP auto-injection Authorized generic of Epipen and Epipen Jr Auto-Injector January 2017 Mylan Anaphylaxis December 2016 bimatoprost Latisse Allergan Dermatologics Eyelash growth December 2016 armodafinil Nuvigil Cephalon Improve wakefulness in patients with November 2016 excessive sleepiness associated certain disorders fluoxetine tablets Sarafem Actavis Premenstrual dysphoric disorder November 2016 olmesartan/amlodipine/ Tribenzor Daiichi Sankyo Hypertension November 2016 hydrochlorothiazide amlodipine/olmesartan Azor Daiichi Sankyo Hypertension November 2016 hydromorphone XR Exalgo Mallinckrodt Brand Pain October 2016 Pharma Yuvafem (estradiol vaginal tab) Vagifem Novo Nordisk Vaginitis October 2016 flurandrenolide lotion Cordran Aqua Eczema October 2016 valganciclovir solution Valcyte Genetech CMV September 2016 sumatriptan nasal spray, Imitrex nasal spray Glaxo Smith Kline Migraine August 2016 5 mg/act and 20 mg/act ethacrynic acid Edecrin Valeant Edema August 2016 nilutamide Nilandron Concordia Metastatic prostate cancer July 2016 / Covis omeprazole/sodium bicarbonate Zegerid powder pack Valeant For treatment of duodenal ulcer, GERD July 2016 for suspension pramipexole ER Mirapex ER 3.75 mg Boehringer Ingelheim Parkinson s disease July 2016 clindamycin phosphate/tretinoin Ziana gel Valeant Acne July 2016 fenofibrate Fenoglide Valeant High cholesterol July 2016 * 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 Monthly Update: June 2017 Page 7 Generics of top selling brand drugs potentially available soon Generic name Brand name Manufacturer Indication(s) To market date* eletriptan Relpax Pfizer Migraines 2017 oseltamivir phosphate suspension Tamiflu Roche/Genetech Influenza 2017 moxifloxacin ophthalmic solution Vigamox Alcon/Novartis Infection July 2017 prasugrel Effient Eli Lilly/Daiichi Sankyo Heart August 2017 exenatide Byetta AstraZeneca Diabetes October 2017 sildenafil citrate Viagra Pfizer ED December 2017 tadalafil Cialis Lilly ED December 2017 2018 glatiramer acetate 40 mg/ml Copaxone Teva Multiple sclerosis 2017 2018 *Expected to market dates are predictions made by Prime Therapeutics based on industry information. Reference 1. http://www.biopharmadive.com/news/adamis-fda-approval-epipen-alternative-symjepi/445217/ All brand names are property of their respective owners. 2992-A1 Prime Therapeutics LLC 06/17