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Drug Pipeline Monthly Update

New drug information ● Slynd™ (drospirenone): Exeltis’ Slynd, an oral progesterone only pill (POP) for pregnancy prevention,

has been approved by the U.S. Food and Drug Administration (FDA). Slynd is the only POP for pregnancy prevention with 24 active and 4 inactive tablets with a 24-hour missed pill window allowed. Combined oral contraceptives (i.e., contain estrogen and a progestin) are contraindicated in women with thromboembolic disorders. Slynd is not contraindicated in women with thromboembolic disorders as there was not an increase in thromboembolic events in women taking Slynd in clinical trials. Launch is anticipated in the fall of 2019.1

● Ortikos™ (budesonide): Sun Pharma received FDA approval for Ortikos for the treatment of mild to moderate active Crohn’s disease; as well as maintenance of clinical remission of mild to moderate Crohn’s disease. Launch plans are pending.

Generic drug information ● Faslodex® (fulvestrant injection): Sandoz launched their generic version of AstraZeneca’s Faslodex

for the treatment of certain forms of breast cancer. Other manufacturers are set to launch their generic versions of Faslodex in 2021. Faslodex had $533 million in annual U.S. sales in 2018.

● Revatio®+ (sildenafil oral suspension 10mg/ml): Novitium launched their generic version of Pfizer’s Revatio for the treatment of pulmonary arterial hypertension. Novitium will lose exclusivity in November 2019. Revatio oral suspension had $187 million in annual U.S. sales in 2018.

● Naftin® (naftifine gel 1%): Tolmar/Amneal launched their generic version of Sebela’s Naftin Gel 1% for the topical treatment of certain fungal infections. Naftin Gel 1% is not protected by patents or regulatory exclusivities. Naftin had <$10 million in annual U.S. 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.

June 2019

Critical updates in an ever changing environment

Drug Pipeline Monthly Update: June 2019

New molecular entity approvals in the past twelve monthsGeneric name Brand name Manufacturer Indication(s) Date approved*

solriamfetol Sunosi™ Jazz Narcolepsy or obstructive sleep apnea (OSA)

March 2019

brexanolone Zulresso™ Sage Therapeutics Postpartum depression March 2019

triclabendazole Egaten® Novartis Fascioliasis February 2019

prucalopride Motegrity™ Shire Chronic idiopathic constipation December 2018

rifamycin Aemcolo™ Cosmo Pharmaceuticals

Travelers' diarrhea November 2018

revefenacin Yupelri™ AcelRx Pharmaceuticals

COPD November 2018

baloxavir marboxil Xofluza™ Shinogi & Co Influenza October 2018

omadacycline Nuzyra™ Paratek Pharmaceuticals

Pneumonia and skin infections October 2018

sarecycline Seysara™ Allergan and Paratek Pharmaceuticals

Acne October 2018

galcanezumab-gnlm Emgality™ Eli Lilly Prevention of migraine September 2018

fremanezumab-vfrm Ajovy™ Teva Prevention of migraine September 2018

doravirine Pifeltro™ Merck HIV September 2018

eravacycline Xerava™ Tetraphase Pharma Complicated intra-abdominal infections September 2018

segesterone acetate/ ethinyl estradiol

Annovera™ TherapeuticsMD Inc Pregnancy prevention August 2018

elagolix Orilissa® AbbVie Pain with endometriosis July 2018

tafenoquine Krintafel® GSK Radical cure of P. vivax malaria July 2018

tecovirimat Tpoxx™ Siga Technologies Smallpox July 2018

glycopyrronium tosylate Qbrexa™ Dermina Excessive sweating July 2018

plazomicin Zemdri™ Achaogen Complicated urinary tract infections July 2018

*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.


Other new product approvals in the past twelve months

Generic name Brand name Manufacturer Indication(s) Date approved*

budesonide Ortikos™ Sun Pharma Crohn’s disease June 2019

drospirenone Slynd™ Exeltis Pregnancy prevention June 2019

dapagliflozin, saxagliptin and metformin hydrochloride

Qternmet XR™ AstraZeneca Type 2 diabetes May 2019

midazolam Nayzilam™ UCB and Proximagen Seizures May 2019

halobetasol propionate and tazarotene

Duobrii™ Ortho Dermatologics (Valeant)

Plaque psoriasis April 2019

ivabradine solution Corlanor™ Amgen To reduce the risk of hospitalization for worsening heart failure in pediatric patients

April 2019

dolutegravir and lamivudine Dovato™ Viiv Healthcare HIV April 2019

colesevelam hydrochloride Welchol™ Daiichi Sankyo, Inc High cholesterol and type 2 diabetes April 2019

acyclovir ophthalmic ointment Avaclyr™ Fera Acute herpetic keratitis in patients with herpes simplex virus

March 2019

tegaserod Zelnorm™ Sloan Pharma Irritable bowel syndrome with constipation in women less than 65 years of age

March 2019

aclidinium and formoterol Duaklir™ Circassia and AstraZeneca

Chronic obstructive pulmonary disease (COPD)

March 2019

testosterone undecanoate Jatenzo™ Clarus Therapeutics Testosterone deficiency March 2019

efavirenz, lamivudine, and tenofovir disoproxil fumarate

Symfi™ Macleods Pharam USA, Inc.

HIV March 2019

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/ Dr. Reddy’s

Migraine January 2019

diclofenac epolamine Licart™ Institut Biochimique Acute pain December 2018

levetiracetam Elepsia XR™ Sun Pharma Partial-onset seizures December 2018

buprenorphine Brixadi™

(tentative approval)Braeburn Pharmaceuticals

Opioid use disorder December 2018

levodopa Inbrija™ Accorda Therapeutics Parkinson’s disease December 2018

rosuvastatin Ezallor™ Sun Pharma Global High cholesterol December 2018

itraconazole capsule Tolsura™ Mayne Pharma Fungal infections December 2018

lamivudine/tenofovir disoproxil fumarate

Temixys™ Celltrion HIV November 2018

continued



sufentanil Dsuvia™ AcelRx Pharmaceuticals

Pain November 2018

clobazam oral soluble film (OSF) Sympazan™ Aquestive Therapeutics

Lennox-Gastaut syndrome November 2018

levoleucovorin Khapzory™ Spectrum Rescue after high-dose methotrexate therapy

October 2018

halobetasol propionate lotion 0.01%

Bryhali™ Bausch Health Cos Inc (Valeant)

Plaque psoriasis October 2018

meloxicam orally disintegrating tables

Qmiiz ODT™ TerSera Pain and inflammation October 2018

estradiol and progesterone Bijuva™ TherapeuticsMD Vasomotor symptoms due to menopause October 2018

testosterone enanthate Xyosted™ Antares Testosterone replacement therapy October 2018

latanoprost Xelpros™ Sun Pharma Open-angle glaucoma September 2018

buprenorphine/naloxone SL film Cassipa™ Teva Opioid dependence September 2018

doravirine, lamivudine and tenofovir disoproxil fumarate

Delstrigo™ Merck HIV September 2018

loteprednol etabonate Inveltys™ Kala Pharmaceuticals Post-operative inflammation and pain following ocular surgery

September 2018

tretinoin Altreno™ Ortho Dermatologic Acne September 2018

methylphenidate Jornay PM™ Ironshore Pharmaceuticals

ADHD August 2018

cyclosporine Cequa™ Sun Pharma Dry eye disease August 2018

tafenoquine Arakoda™ 60 Degrees Pharmaceuticals

Prevention of malaria August 2018

risperidone injectable Perseris™ Indivior Schizophrenia August 2018

pimavanserin, 34 mg capsule, 10 mg tablet

Nuplaxid® Acadia Pharmaceutical

Parkinson’s disease psychosis July 2018

darunavir, cobicistat, emtricitabine, tenofovir alafenamide

Symtuza® Janssen HIV July 2018

aripiprazole lauroxil Aristada Initio™ Alkermes Schizophrenia July 2018

desmopressin Nocdurna™ Ferring Pharmaceuticals

Nocturia July 2018

*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

Other new product approvals in the past twelve months (continued)


Generic Name Brand Name Manufacturer Indication(s)Anticipated FDA Decision Date

loxicodegol N/A Nektar Therapeutics Chronic lower back pain 2019

glucagon rescue pen XeriSol Glucagon™ Xeris Pharmaceuticals

Severe hypoglycemia June 2019

tiopronin Thiola® Mission Pharmcal and Retrophin

Cystinuria June 2019

bremelanotide Vyleesi™ AMAG/Palatin Hypoactive sexual desire disorder in women

June 2019

diazepam Valtoco™ Neurelis Acute seizures 3Q2019

relebactam, cilastatin and imipenem

N/A Merck Complicated urinary tract infection (cUTI) or complicated intra-abdominal infection (cIAI)

July 2019

loteprednol etabonate N/A Kala Pharmaceuticals Dry eye disease August 2019

lefamulin N/A Nabriva Therapeutics Community acquired bacterial pneumonia August 2019

pitolisant N/A Harmony Narcolepsy August 2019

istradefylline N/A Kyowa Kirin Parkinson’s disease August 2019

oxycodone controlled-release Rexista™ Intellipharmaceutics Pain August 2019

tenapanor N/A Ardelyx Irritable bowel syndrome with constipation September 2019

lumateperone N/A Intra-cellular therapies

Schizophrenia September 2019

ferric maltol Ferracru™ Shield Therapeutics Iron deficiency October 2019

cetirizine Qzytir™ JDP Therapeutics Acute urticaria October 2019

lasmiditan N/A Lilly Migraine October 2019

triamcinolone acetonide Xipere™ Clearside Medical Macular edema with uveitis October 2019

minocycline foam 4% FMX 101 Foamix Pharmaceuticals

Acne vulgaris October 2019

testosterone undecanoate Tlando™ Lipocine Oral testosterone November 2019

cenobamate N/A SK Biopharmaceuticals

Partial-onset seizures November 2019

ethinyl estradiol and levonorgestrel

Twirla™ Agile Therapeutics Contraceptive patch November 2019

ubrogepant N/A Allergan Acute migraine December 2019

lemborexant N/A Eisai/Prudue Pharma Insomnia December 2019

semaglutide N/A Novo Nordisk Reduction of CV risk in T2DM January 2020

bempedoic acid/ezetimibe N/A Esperion Therapeutics

High cholesterol February 2020

eptinezumab N/A Adler BioPharmaceuticals

Migraine prevention February 2020

bempedoic acid N/A Esperion Therapeutics

High cholesterol February 2020

Pipeline watch



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™ (fluticasone/salmeterol)

Advair Diskus® Glaxo Smith Kline Asthma and COPD February 2019

acyclovir Zovirax® Bausch Health Cold sores February 2019

cinacalcet Sensipar® Amgen Hyperparathyroidism or hypercalcemia January 2019

pimecrolimus Elidel® Valeant Atopic dermatitis January 2019

mesalamine Canasa® Allergan Ulcerative proctitis December 2018

epinephrine auto-injector, 0.3 mg Epipen® Mylan Specialty The emergency treatment of allergic reactions

December 2018

clobazam tablet Onfi® Lundbeck Lennox-Gastaut syndrome November 2018

testosterone Androgel® 1.62% pump

Abbvie Testosterone replacement therapy (TRT) October 2018

tadalafil Cialis® Lilly Benign prostatic hyperplasia (BPH) and erectile dysfunction (ED)

October 2018

tadalafil Adcirca® Lilly PAH August 2018

mesalamine DR Asacol HD® Allergan Ulcerative colitis August 2018

* 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


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 Wilson’s disease

May 2019

valrubicin Valstar® Endo Bladder cancer April 2019

ambrisentan+ Letairis® Gilead Sciences Pulmonary arterial hypertension April 2019

aliskiren Tekturna® Noden Pharma USA Hypertension April 2019

First generic approvals of top selling brand name drugs in the past twelve months

Other first generic launches in the past twelve months

continued



treprostinil sodium+ Remodulin® United Therapeutics Corp

Pulmonary arterial hypertension (PAH) March 2019

ranolazine ER Ranexa® Gilead Sciences Chronic angina March 2019

minocycline ER Solodyn® Bausch Health Acne March 2019

erythromycin ethylsuccinate EryPed 400® Arbor Pharmaceuticals

Infection caused by listeria and bordetella 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

aminocaproic acid Amicar® Clover Pharmaceuticals

Hemostasis December 2018

silodosin Rapaflo® Allergan BPH December 2018

abiraterone tab+ Zytiga® Janssen Biotech Cancer chemotherapy November 2018

testosterone transdermal gel pump

Fortesta® Endo Pharmaceuticals

TRT November 2018

buprenorphine Butrans® Purdue Pain November 2018

estradiol patch Minivelle® Noven Therapeutics Menopause November 2018

vardenafil Staxyn® Bayer Erectile dysfunction November 2018

glycopyrrolate tablet Glycate® Carwin Pharmaceutical Associates

Peptic ulcer disease (PUD) November 2018

vardenafil Levitra® Bayer Erectile dysfunction October 2018

itraconazole oral solution Sporanox® Janssen Fungal infections September 2018

dalfampridine ER+ Ampyra® Acorda Therapeutics Multiple sclerosis September 2018

carmustine BiCNU® Heritage Cancer chemotherapy September 2018

nevirapine Viramune® Boehringer Ingelheim HIV September 2018

albendazole Albenza® Amedra Parasitic disease September 2018

dorzolamide/timolol Cosopt PF® Merck Sharp & Dohme

Glaucoma August 2018

dexamethasone Dexpak® Valeant Inflammation/allergic reactions/ autoimmune diseases

August 2018

crotamiton Eurax® Ranbaxy Scabies and itchy skin August 2018

desoximetasone Topicort® Topical Spray

Taro Plaque psoriasis August 2018

colesevelam oral suspension Welchol® Sankyo High cholesterol/diabetes July 2018

budesonide Uceris® Valeant Ulcerative colitis July 2018

* 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.


Other first generic launches in the past twelve months (continued)


2992-A1 © Prime Therapeutics LLC 06/19

References1. https://www.biospace.com/article/releases/exeltis-usa-inc-announces-the-approval-of-slynd-the-first-and-only-progestin-only-pill-providing-pregnancy-prevention-with-a-24-4-dosing-regimen-and-

24-hour-missed-pill-window/

All brand names are property of their respective owners.

Generics of top selling brand drugs potentially available soon

Generic name Brand name Manufacturer Indication(s) To market date*

cyclosporine Restasis® Allergan Dry eye 2019

ascorbic acid; PEG; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate

Moviprep® Salix Valeant Osmotic laxative 2019

difluprednate Durezol® Alcon/Novartis Eye inflammation 2019

exenatide Byetta® AstraZeneca Diabetes 2019

ethinyl estradiol/etonogestrel NuvaRing® Organon/Merck & Co Pregnancy prevention 1H2019

albuterol sulfate Proventil® HFA/ProAir® HFA

Merck/Teva Asthma/COPD 2H2019

ramelteon Rozerem® Takeda Insomnia 2H2019

pregabalin Lyrica® Pfizer CNS July 2019

teriparatide+ Forteo® Lilly Osteoporosis November 2019

icatibant acetate+ Firazyr® Shire HAE 2019

deferasirox+ Jadenu® Novartis Iron overload 2019

tolvaptan+ Samsca® Otsuka Hypernatremia 2019

travoprost Travatan Z® Alcon Glaucoma 2019

dapsone Aczone 7.5%® Allergan Acne January 2020

topiramate Qudexy XR® Upsher-Smith Seizures March 2020

vilazodone hydrochloride Viibryd® Forest Depression 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 May 2020

ipratropium Atrovent HFA® Boehringer Ingelheim Chronic obstructive pulmonary disease (COPD)

May 2020

* Expected to market dates are predictions made by Prime based on industry information.


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