Generic Launches

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Spring 2015

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Diovan	Novartis	valsartan tablets	Mylan	treatment of hypertension	1/5/2015
Diovan	Novartis	valsartan tablets	Lupin Pharms.	treatment of hypertension	1/6/2015
Diovan	Novartis	valsartan tablets	Teva	treatment of hypertension	1/6/2015
Clobex	Galderma Labs.	clobetasol propionate spray	Perrigo	topical treatment of moderate to severe plaque psoriasis	1/12/2015
AndroGel 1.0%	AbbVie	AB therapeutic equivalent testosterone gel 1.0%	Perrigo	treat adult males who have low or no testosterone	1/12/2015
Colcrys	Takeda Pharms. America	colchicine tablets	Prasco	prophylaxis and treatment of acute gout flares in adults, and the treatment of familial Mediterranean fever (FMF) in adults and children age 4 or older	1/12/2015
Epivir-HBV	GlaxoSmithKline	lamivudine tablets	Mylan	treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation	1/15/2015
Vancocin	ANI Pharms.	vancomycin hydrochloride capsules	Lupin	treatment of C. difficile- associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)	2/2/2015
Pulmicort Respules	AstraZeneca	budesonide inhalation suspension	Actavis	control and prevent asthma symptoms in children ages 12 months to 8 years	2/9/2015
Lovenox	Sanofi Aventis	enoxaparin sodium injection	Teva (and Chemi SPA)	prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in the medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT	2/17/2015
Zyvox	Pharmacia and Upjohn	linezolid injection	Teva (and Chemi SPA)	treatment of infections caused by Gram-positive bacteria	2/17/2015
Subutex	Reckitt Benckiser	buprenorphine tablets	Actavis	treatment of opioid dependence	2/20/2015
Lumigan	Allergan	bimatoprost ophthalmic solution, 0.03%	Lupin	reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension	2/23/2015
Seasonique	Teva Women's Health	levonorgestrel / ethinyl estradiol and ethinyl estradiol extended-cycle oral contraceptive tablets	Glenmark Generics	use by women to prevent pregnancy	2/25/2015
Tarka	AbbVie	trandolapril / verapamil hydrochloride extended-release tablets	Glenmark Generics	treatment of hypertension	2/26/2015
Temovate	Fougera	clobetasol cream 0.05%	Actavis	relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses	3/9/2015
Antabuse	Odyssey Pharm.	disulfiram tablets	Mylan	aid in management of selected chronic alcohol patients who want to remain in a state of enforced sobriety	3/11/2015
Subutex	Reckitt Benckiser	buprenorphine hydrochloride sublingual tablets	Mylan	treatment of opioid dependence and is preferred for induction	3/11/2015
Exforge	Novartis	amlodipine / valsartan tablets	Mylan	treatment of hypertension, to lower blood pressure: in patients not adequately controlled on monotherapy with DHP CCB or an ARB; as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals	3/31/2015
Exforge	Novartis	amlodipine / valsartan tablets	Sandoz	treatment of hypertension, to lower blood pressure: in patients not adequately controlled on monotherapy with DHP CCB or an ARB; as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals	3/31/2015
Exforge	Novartis	amlodipine / valsartan tablets	Teva	treatment of hypertension, to lower blood pressure: in patients not adequately controlled on monotherapy with DHP CCB or an ARB; as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals	3/31/2015

GENERICally Speaking Spring 2015

Jeffrey Alan Hovden

Partner

Oren D. Langer

Partner

Managing Partner, New York Office

Ryan M. Schultz