Drug Pipeline Monthly Update
Critical updates in an ever changing environment
June 2019
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. Drug Pipeline Monthly Update: June 2019 Page 2
New molecular entity approvals in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* 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
prucalopride Motegrity™ Shire Chronic idiopathic constipation December 2018
rifamycin Aemcolo™ Cosmo Travelers' diarrhea November 2018 Pharmaceuticals revefenacin Yupelri™ AcelRx COPD November 2018 Pharmaceuticals baloxavir marboxil Xofluza™ Shinogi & Co Influenza October 2018
omadacycline Nuzyra™ Paratek Pneumonia and skin infections October 2018 Pharmaceuticals sarecycline Seysara™ Allergan and Paratek Acne October 2018 Pharmaceuticals 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/ Annovera™ TherapeuticsMD Inc Pregnancy prevention August 2018 ethinyl estradiol 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. Drug Pipeline Monthly Update: June 2019 Page 3
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 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
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 diclofenac epolamine Licart™ Institut Biochimique Acute pain December 2018
levetiracetam Elepsia XR™ Sun Pharma Partial-onset seizures December 2018
buprenorphine Brixadi™ Braeburn Opioid use disorder December 2018 (tentative approval) Pharmaceuticals 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 Temixys™ Celltrion HIV November 2018 fumarate
continued Drug Pipeline Monthly Update: June 2019 Page 4
Other new product approvals in the past twelve months (continued)
Generic name Brand name Manufacturer Indication(s) Date approved* sufentanil Dsuvia™ AcelRx Pain November 2018 Pharmaceuticals clobazam oral soluble film (OSF) Sympazan™ Aquestive Lennox-Gastaut syndrome November 2018 Therapeutics levoleucovorin Khapzory™ Spectrum Rescue after high-dose methotrexate October 2018 therapy halobetasol propionate lotion Bryhali™ Bausch Health Cos Plaque psoriasis October 2018 0.01% Inc (Valeant) meloxicam orally disintegrating Qmiiz ODT™ TerSera Pain and inflammation October 2018 tables 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 Delstrigo™ Merck HIV September 2018 tenofovir disoproxil fumarate loteprednol etabonate Inveltys™ Kala Pharmaceuticals Post-operative inflammation and pain September 2018 following ocular surgery tretinoin Altreno™ Ortho Dermatologic Acne September 2018
methylphenidate Jornay PM™ Ironshore ADHD August 2018 Pharmaceuticals cyclosporine Cequa™ Sun Pharma Dry eye disease August 2018
tafenoquine Arakoda™ 60 Degrees Prevention of malaria August 2018 Pharmaceuticals risperidone injectable Perseris™ Indivior Schizophrenia August 2018
pimavanserin, 34 mg capsule, Nuplaxid® Acadia Parkinson’s disease psychosis July 2018 10 mg tablet Pharmaceutical darunavir, cobicistat, Symtuza® Janssen HIV July 2018 emtricitabine, tenofovir alafenamide aripiprazole lauroxil Aristada Initio™ Alkermes Schizophrenia July 2018
desmopressin Nocdurna™ Ferring Nocturia July 2018 Pharmaceuticals *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 2019 Page 5
Pipeline watch
Anticipated FDA Generic Name Brand Name Manufacturer Indication(s) Decision Date loxicodegol N/A Nektar Therapeutics Chronic lower back pain 2019
glucagon rescue pen XeriSol Glucagon™ Xeris Severe hypoglycemia June 2019 Pharmaceuticals tiopronin Thiola® Mission Pharmcal Cystinuria June 2019 and Retrophin bremelanotide Vyleesi™ AMAG/Palatin Hypoactive sexual desire disorder in June 2019 women diazepam Valtoco™ Neurelis Acute seizures 3Q2019
relebactam, cilastatin and N/A Merck Complicated urinary tract infection (cUTI) July 2019 imipenem or complicated intra-abdominal infection (cIAI) 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 Schizophrenia September 2019 therapies 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 Acne vulgaris October 2019 Pharmaceuticals testosterone undecanoate Tlando™ Lipocine Oral testosterone November 2019
cenobamate N/A SK Partial-onset seizures November 2019 Biopharmaceuticals ethinyl estradiol and Twirla™ Agile Therapeutics Contraceptive patch November 2019 levonorgestrel 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 High cholesterol February 2020 Therapeutics eptinezumab N/A Adler Migraine prevention February 2020 BioPharmaceuticals bempedoic acid N/A Esperion High cholesterol February 2020 Therapeutics Drug Pipeline Monthly Update: June 2019 Page 6
First generic approvals of top selling brand name drugs in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* 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
mesalamine Canasa® Allergan Ulcerative proctitis December 2018
epinephrine auto-injector, 0.3 mg Epipen® Mylan Specialty The emergency treatment of allergic December 2018 reactions clobazam tablet Onfi® Lundbeck Lennox-Gastaut syndrome November 2018
testosterone Androgel® 1.62% Abbvie Testosterone replacement therapy (TRT) October 2018 pump tadalafil Cialis® Lilly Benign prostatic hyperplasia (BPH) and October 2018 erectile dysfunction (ED) 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
Other first generic launches in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* naftifine gel, 1% Naftin gel® Amneal Fungal infections June 2019 Pharmaceuticals sildenafil for suspension+ Revatio® Pfizer Pulmonary arterial hypertension June 2019
mifepristone Mifeprex® Dance Laboratories Termination of pregnancy May 2019
bosentan+ Tracleer® Actelion Pulmonary hypertension May 2019 Pharmaceuticals mesalamine Delzicol® Allergan IBD May 2019
penicillamine+ Cuprimine® Bausch Health Hepatic encephalopathy and Wilson’s May 2019 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
continued Drug Pipeline Monthly Update: June 2019 Page 7
Other first generic launches in the past twelve months (continued)
Generic name Brand name Manufacturer Indication(s) Date approved* treprostinil sodium+ Remodulin® United Therapeutics Pulmonary arterial hypertension (PAH) March 2019 Corp ranolazine ER Ranexa® Gilead Sciences Chronic angina March 2019
minocycline ER Solodyn® Bausch Health Acne March 2019
erythromycin ethylsuccinate EryPed 400® Arbor Infection caused by listeria and bordetella March 2019 Pharmaceuticals 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 Hemostasis December 2018 Pharmaceuticals silodosin Rapaflo® Allergan BPH December 2018
abiraterone tab+ Zytiga® Janssen Biotech Cancer chemotherapy November 2018
testosterone transdermal gel Fortesta® Endo TRT November 2018 pump Pharmaceuticals 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 Peptic ulcer disease (PUD) November 2018 Pharmaceutical Associates 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 & Glaucoma August 2018 Dohme dexamethasone Dexpak® Valeant Inflammation/allergic reactions/ August 2018 autoimmune diseases crotamiton Eurax® Ranbaxy Scabies and itchy skin August 2018
desoximetasone Topicort® Taro Plaque psoriasis August 2018 Topical Spray 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. +Specialty medication Drug Pipeline Monthly Update: June 2019 Page 8
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 Moviprep® Salix Valeant Osmotic laxative 2019 chloride; sodium ascorbate; sodium chloride; sodium sulfate 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/ Merck/Teva Asthma/COPD 2H2019 ProAir® HFA 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 A c z o n e 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 Lice May 2020 Pharmaceuticals varenicline tartrate Chantix® Pfizer Smoking cessation May 2020
mometasone/formoterol Dulera® Merck & Co Asthma May 2020 fumarate ipratropium Atrovent HFA® Boehringer Ingelheim Chronic obstructive pulmonary disease May 2020 (COPD) * Expected to market dates are predictions made by Prime based on industry information. +Specialty medication
References 1. 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.
2992-A1 © Prime Therapeutics LLC 06/19