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Drug Pipeline MONTHLY UPDATE

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Drug Pipeline MONTHLY UPDATE Drug Pipeline MONTHLY UPDATE Critical updates in an ever changing environment December 2019 NEW DRUG INFORMATION ™ ● Xcopri (cenobamate): The U.S. Food and Drug Administration (FDA) approved SK Biopharmaceuticals’ Xcopri as an antiepileptic drug for treatment of partial-onset seizures in adults. The approval is based on results from two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drug (AEDs). In these studies, Xcopri demonstrated significant reductions in seizure frequency compared to placebo.1 Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with Xcopri use. It has not been established that the risk of DRESS is prevented by a slower titration; however, it should be initiated at 12.5 mg once daily and titrated every two weeks. Xcopri is expected to be available in the United States 2Q2020, after scheduling review by the DEA, which typically occurs within 90 days of FDA approval. Price pending. GENERIC DRUG INFORMATION ® + ● Jadenu (deferasirox): Multiple manufacturers have launched their generic version of Novartis’ Jadenu for treatment of chronic iron overload. Jadenu generated $474 million in U.S. annual sales in 2018. ® ● Apriso (mesalamine ER): Multiple manufactures have launched their generic version of Bausch Health’s Apriso for treatment of ulcerative colitis. Apriso generated $312 million in U.S. annual sales in 2018. ® ● Nubupent (pentamidine isethionate): Fresenius launched their generic version of Seton Pharmaceuticals Nebupent inhaled solution for treatment of complicated lung infections. Nubupent does not have any further regulatory exclusivities. Nubupent U.S. sales for 2018 are not published. ® ● Carafate (sucralfate suspension): Amneal launched their generic version of Forest/Allergan’s Carafate suspension for treatment of ulcers. Carafate oral suspension is not protected by any patents or regulatory exclusivities. Carafate generated $245 million in U.S. annual sales in 2018. ® ● NuvaRing (etonogestrel/ethinyl estradiol): Amneal launched their generic version of Organon’s NuvaRing for pregnancy prevention. Multiple manufacturers are set to launch their generics in 2020. NuvaRing generated $926 million in U.S. annual sales in 2018. ® + ● Afinitor (everolimus): Par/Endo launched their generic version of Novartis’ Afinitor for treatment of certain forms of cancer. Multiple manufacturers are set to launch their generics in mid-2020. Afinitor generated $373 million in U.S. annual sales in 2018. + Specialty medication 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: December 2019 Page 2 NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* lasmiditan Reyvow® Lilly Acute migraine October 2019 tenapanor Ibsrela® Ardelyx IBS-C September 2019 istradefylline Nourianz™ Kyowa Kirin’s Parkinson’s disease ‘off’ episodes September 2019 pitolisant Wakix™ Harmony Narcolepsy August 2019 imipenem, cilastatin and Recarbrio™ Merck Complicated UTI and infections July 2019 relebactam solriamfetol Sunosi™ Jazz Narcolepsy or obstructive sleep apnea March 2019 (OSA) brexanolone Zulresso™ Sage Therapeutics Postpartum depression March 2019 triclabendazole Egaten® Novartis Fascioliasis February 2019 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: December 2019 Page 3 OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* cenobamate Xcopri™ SK Biopharmaceuticals Antiepileptic November 2019 cefiderocol Fetroja™ Shionogi Complicated urinary tract infections (cUTI) November 2019 rifabutin, amoxicillin and Talicia™ RedHill Helicobacter pylori November 2019 omeprazole minocycline foam 4% Amzeeq™ Foamix Acne vulgaris October 2019 Pharmaceuticals asenapine Secuado™ Noven Schizophrenia October 2019 Pharmaceuticals cetirizine, injectable Quzyttir™ JDP Therapeutics Acute urticaria October 2019 trifarotene cream Aklief™ Galderma Laboratories Acne October 2019 dexamethasone Hemady™ Dexcel Multiple myeloma October 2019 baclofen Ozobax™ Metacel Muscle relaxant September 2019 Pharmaceuticals fosaprepitant Fosaprepitant™ Teva Chemotherapy-induced nausea and September 2019 vomiting glucagon injection Gvoke™ Xeris Pharmaceuticals Severe hypoglycemia in diabetes September 2019 metformin HCl for extended- Riomet ER® Sun Pharma Type 2 diabetes September 2019 release oral suspension semaglutide Rybelsus® Novo Nordisk Type 2 diabetes September 2019 ferric maltol Accrufer™ Shield Therapeutics Iron deficiency July 2019 nasal glucagon Bagsimi™ Lilly Hypoglycemia July 2019 duloxetine DR Drizalma Sprinkle™ Sun Depression, anxiety and neuropathic pain July 2019 amlodipine benzoate suspension Katerzia™ Silvergate Pharms Hypertension July 2019 tiopronin DR Thiola EC™ Mission Pharmacal/ Cystinuria July 2019 Retrophin budesonide Ortikos™ Sun Pharma Crohn’s disease June 2019 drospirenone Slynd™ Exeltis Pregnancy prevention June 2019 dapagliflozin, saxagliptin and Qternmet XR™ AstraZeneca Type 2 diabetes May 2019 metformin hydrochloride midazolam Nayzilam™ UCB and proximagen Seizures May 2019 halobetasol propionate and Duobrii™ Ortho Dermatologics Plaque psoriasis April 2019 tazarotene (Valeant) ivabradine solution Corlanor™ Amgen To reduce the risk of hospitalization for April 2019 worsening heart failure in pediatric patients dolutegravir and lamivudine Dovato™ Viiv Healthcare HIV April 2019 colesevelam hydrochloride Welchol™ Daiichi Sankyo, Inc High cholesterol and type 2 diabetes April 2019 continued Drug Pipeline Monthly Update: December 2019 Page 4 OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* acyclovir ophthalmic ointment Avaclyr™ Fera Acute herpetic keratitis in patients with March 2019 herpes simplex virus tegaserod Zelnorm™ Sloan Pharma Irritable bowel syndrome with constipation March 2019 in women less than 65 years of age aclidinium and formoterol Duaklir™ Circassia and Chronic obstructive pulmonary disease March 2019 AstraZeneca (COPD) testosterone undecanoate Jatenzo™ Clarus Therapeutics Testosterone deficiency March 2019 efavirenz, lamivudine, and Symfi™ Macleods Pharam HIV March 2019 tenofovir disoproxil fumarate USA, Inc. netarsudil/latanoprost Rocklatan™ Aerie Glaucoma or ocular hypertension March 2019 methylphenidate hydrochloride Adhansia XR™ Adlon Therapeutics ADHD February 2019 loteprednol etabonate Lotemax SM™ Bausch + Lomb Post-operative inflammation and pain February 2019 prabotulinumtoxin A-xvfs Jeuveau™ Evolus Frown lines February 2019 amphetamine sulfate Evekeo ODT™ Arbor Phars ADHD January 2019 colchicine Gloperba™ Romeg Therapeutics Prevention of gout flares January 2019 sumatriptan nasal spray Tosymra™ Promius Pharma/ Migraine January 2019 Dr. Reddy’s *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: December 2019 Page 5 PIPELINE WATCH DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* diazepam Valtoco™ Neurelis Acute seizures 3Q2019 ubrogepant N/A Allergan Acute migraine December 2019 IDP-123 (tazarotene) N/A Ortho Dermatologics Acne December 2019 lumateperone N/A Intra-Cellular Therapies Schizophrenia December 2019 lemborexant N/A Eisai/Prudue Pharma Insomnia December 2019 cabotegravir N/A Viiv/Janssen HIV December 2019 cabotegravir/rilpivirine N/A Viiv/Janssen HIV December 2019 bimatoprost sustained-release (SR) N/A Allergan Open-angle glaucoma or ocular January 2020 hypertension risperidone, extended-release Rykindo™ Luye Pharma Group Schizophrenia and bipolar disorder January 2020 injection rimegepant N/A Biohaven Acute migraine February 2020 ethinyl estradiol and levonorgestrel Twirla™ Agile Therapeutics Contraceptive patch February 2020 empagliflozin, linagliptin and N/A Boehringer Ingelheim and Type 2 diabetes February 2020 metforminXR Eli Lilly bempedoic acid N/A Esperion Therapeutics High cholesterol February 2020 bempedoic acid/ezetimibe N/A Esperion Therapeutics High cholesterol February 2020 eptinezumab N/A Adler BioPharmaceuticals Migraine prevention February 2020 naloxone nasal spray N/A Insys Opioid overdose March 2020 bimatoprost SR N/A Allergan Glaucoma March 2020 ET-105 (lamotrigine) N/A Eton Pharmaceuticals Seizures March 2020 ITCA 650 (exenatide, subcutaneous N/A Intarcia Type 2 diabetes March 2020 minipump) rizatriptan, oral film Rizaport™ IntelGenx Migraine March 2020 opicapone N/A Neurocrine Biosciences Parkinson’s disease April 2020 dasotraline N/A Sunovion Binge eating disorder May 2020 apomorphine sublingual N/A Sunovion Parkinson’s disease May 2020 FMX103 (minocycline foam 1.5%) N/A Foamix Pharmaceuticals Severe papulopustular rosacea June 2020 RVL-1201 (oxymetazoline N/A Vertical Pharmaceuticals Acquired blepharoptosis July 2020 ophthalmic solution 0.1%) (Osmotica)
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