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) (droopy eyelid) calcipotriene 0.005% and Wynzora™ MC2 Therapeutics Plaque psoriasis July 2020 betamethasone 0.064% cream veverimer N/A Tricida Metabolic acidosis in patients with August 2020 chronic kidney disease (CKD) clascoterone Winlevi™ Cassiopea SPA Acne August 2020 Drug Pipeline Monthly Update: December 2019 Page 6

FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS BRAND DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* everolimus+ Afinitor® Novartis Certain forms of cancer December 2019

etonogestrel/ethinyl estradiol NuvaRing® Organon Pregnancy prevention December 2019

deferasirox+ Jadenu® Novartis Iron overload November 2019

fosaprepitant dimeglumine Emend® Merck Sharp & Chemotherapy-induced nausea and September 2019 Dohme vomiting posaconazole Noxafil® Merck Sharp & Fungal infections September 2019 Dohme pregabalin Lyrica® Pfizer Neuropathic pain and seizures July 2019

erlotinib+ Tarceva® Genentech Lung cancer May 2019

loteprednol etbonate Lotemax® Bausch Health Allergic conjunctivitis May 2019

solifenacin Vesicare® Astellas Incontinence April 2019

deferasirox Exjade® Novartis Chronic iron overload March 2019

buprenorphine/naloxone Suboxone® Indivior Inc Opioid dependence March 2019

Wixela™ Inhub™ Advair Diskus® Glaxo Smith Kline Asthma and COPD February 2019 (fluticasone/salmeterol) acyclovir Zovirax® Bausch Health Cold sores February 2019

cinacalcet Sensipar® Amgen Hyperparathyroidism or hypercalcemia January 2019

pimecrolimus Elidel® Valeant Atopic dermatitis January 2019

*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. + Specialty medication

OTHER FIRST GENERIC LAUNCHES IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* sucralfate suspension Carafate® Forest/Allergan Ulcers December 2019

pentamidine Nebupent® Seton Pharmaceuticals Serious lung infections December 2019

mesalamine ER Apriso® Bausch Health Ulcerative colitis December 2019

ciprofloxacin/fluocinoloneotic Otovel® Arbor Pharmaceuticals Ear infections November 2019

ivermectin cream, 1% Soolantra® Galderma Rosacea October 2019

aminocaproic acid oral syrup Amicar® Clover Pharmaceuticals Hemostasis September 2019

triamterene Dyrenium® Concordia Edema September 2019

halcinonide Halog® Ranbaxy Itchy skin August 2019

ramelteon Rozerem® Takeda Insomnia August 2019

icatibant injection+ Firazyr® Shire/Takeda HAE July 2019

daptomycin injection Daptomycin® Sagent/Xelia Complicated bacterial infections July 2019

continued Drug Pipeline Monthly Update: December 2019 Page 7

OTHER FIRST GENERIC LAUNCHES IN THE PAST TWELVE MONTHS (continued)

DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* carboprost injection Hemabate® Pfizer Termination of pregnancy July 2019

febuoxostat Uloric® Takeda Hyperuricemia in patients with gout July 2019

doxylamine/pyridoxine DR Diclegis® Duchesnay Nausea and vomiting in pregnancy June 2019

naftifine gel, 1% Naftin gel® Amneal Pharmaceuticals Fungal infections June 2019

sildenafil for suspension+ Revatio® Pfizer Pulmonary arterial hypertension June 2019

mifepristone Mifeprex® Dance Laboratories Termination of pregnancy May 2019

bosentan+ Tracleer® Actelion Pharmaceuticals Pulmonary hypertension May 2019

mesalamine Delzicol® Allergan IBD May 2019

penicillamine+ Cuprimine® Bausch Health Hepatic encephalopathy and May 2019 Wilson’s disease valrubicin Valstar® Endo Bladder cancer April 2019

ambrisentan+ Letairis® Gilead Sciences Pulmonary arterial hypertension April 2019

aliskiren Tekturna® Noden Pharma USA Hypertension April 2019

treprostinil sodium+ Remodulin® United Therapeutics Corp Pulmonary arterial hypertension March 2019 (PAH) ranolazine ER Ranexa® Gilead Sciences Chronic angina March 2019

minocycline ER Solodyn® Bausch Health Acne March 2019

erythromycin ethylsuccinate EryPed 400® Arbor Pharmaceuticals Bacterial infections March 2019

pyridostigmine bromide syrup Mestinon® Bausch Health Myasthenia gravis March 2019

sirolimus Rapamune® Pfizer Prevention of organ rejection February 2019

toremifene+ Fareston® Kyowa Kirin Metastatic breast cancer January 2019

vigabatrin+ Sabril® Lundbeck Partial seizures or infantile spasms January 2019

GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* ascorbic acid; PEG; potassium Moviprep® Salix Valeant Osmotic laxative 2019 chloride; sodium ascorbate; sodium chloride; sodium sulfate tolvaptan+ Samsca® Otsuka Hypernatremia 2019

travoprost Travatan Z® Alcon Glaucoma 2019

dapsone Aczone® 7.5% Allergan Acne 2020

albuterol sulfate Proventil® HFA/ Merck/Teva Asthma/COPD 2020 ProAir® HFA difluprednate Durezol® Alcon/Novartis Eye inflammation 2020

exenatide Byetta® AstraZeneca Diabetes 2020

ethinyl estradiol/etonogestrel NuvaRing® Organon/Merck & Co Pregnancy prevention 2020

teriparatide+ Forteo® Lilly Osteoporosis February 2020

topiramate Qudexy XR® Upsher-Smith Seizures March 2020

ethinyl estradiol Taytulla® Allergan Pregnancy prevention March 2020

ivermectin Sklice® Arbor Pharmaceuticals Lice May 2020

varenicline Tartrate Chantix® Pfizer Smoking cessation May 2020

mometasone/formoterol fumarate Dulera® Merck & Co Asthma November 2020

vilazodone hydrochloride Viibryd® Forest Depression 2021

fluticasone propionate Flovent® GSK Respiratory 2021

nebivolol Bystolic® Allergan Hypertension 2021

dabigatran Pradaxa® Boehringer Ingelheim Anticoagulant 2021 Pharmaceuticals * Expected to market dates are predictions made by Prime based on industry information. + Specialty medication

REFERENCES

1. https://www.prnewswire.com/news-releases/fda-approves-xcopri-cenobamate-tablets-an-anti-epileptic-drug-aed-from-sk-biopharmaceuticals-co-ltd-and-us-subsidiary-sk-life-science-inc-300963478.html.

All brand names are property of their respective owners.