Generic Launches Q2 2012

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

April 04, 2012

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Avapro	Sanofi Aventis	Irbesartan	Teva	High blood pressure treatment	Apr. 2, 2012
Avalide	Sanofi Aventis	Irbesartan-hydrochlorothiazide	Teva	High blood pressure treatment	Apr. 2, 2012
Sular Extended Release	Shionogi	Nisoldipine extended release tablets	Prasco	Treatment of high blood pressure	Apr. 2, 2012
Mesnex Injection	Baxter Healthcare	Mesna injection	Mylan	Prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis	Apr. 3, 2012
Provigil	Cephalon/Teva	Modafinil tablets	Par Pharmaceutical	Wakefulness-promoting agent	Apr. 6, 2012
Vancocin HCl Capsules	ViroPharma	Vancomycin hydrochloride	Watson Pharmaceuticals	Treatment of C. difficile-associated diarrhea and enterocolitis	Apr. 10, 2012
Vancocin HCl Capsules	ViroPharma	Vancomycin hydrochloride	Akorn	Treatment of C. difficile-associated diarrhea and enterocolitis	Apr. 10, 2012
Vancocin HCl Capsules	ViroPharma	Vancomycin hydrochloride	Prasco	Treatment of C. difficile-associated diarrhea and enterocolitis	Apr. 11, 2012
Mucinex	Adams Respiratory Therapeutics	Guaifenesin extended-release tablets	Perrigo	Relieve chest congestion and make coughs more productive	Apr. 12, 2012
Lescol Capsules	Novartis	Fluvastatin capsules	Mylan	Familial and nonfamilial hypercholesterolemia and mixed dyslipidemia	Apr. 13, 2012
Fortamet	Shionogi	Metformin hydrochloride extended-release tablets	Watson Pharmaceuticals	Adjunct to diet and exercise to lower blood glucose	Apr. 19, 2012
Zyprexa Tablets	Eli Lilly and Company	Olanzapine	Mylan	Treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar 1 disorder and maintenance treatment of bipolar 1 disorder	Apr. 24, 2012
Stalevo	Orion Corporation/Novartis	Levodopa, carbidopa and entacapone	Wockhardt	Treatment of Parkinson's disease	Apr. 24, 2012
Doryx	Mayne Pharmaceutical	Dolycycline hyclate delayed-release tablets	Mylan	Antimicrobial	Apr. 30, 2012
Plavix	Sanofi Aventis	Clopidogrel tablets	Mylan	Acute coronary syndrome and recent myocardial infarction, stroke or established peripheral arterial disease	May. 17, 2012
Prevacide 24HR Capsules	Novartis	Lansoprazole	Perrigo	Treatment of frequent heartburn	May. 18, 2012
Requip XL	GlaxoSmithKline	Ropinirole extended-release tablets.	Actavis	Treatment for Parkinson's disease	May. 18, 2012
Viramune Tablets	Boehringer Ingelheim	Nevirapine tablets.	Mylan	Combination antiretroviral treatment of HIV-1 infection	May. 23, 2012
Lipitor	Pfizer	Atorvastatin calcium tablets	Mylan	Treatment of hypercholesterolemia and mixed dyslipidemia	May. 29, 2012
Adalat CC	Bayer	Nifedipine extended-release tablets	Actavis	Treatment of hypertension	May. 30, 2013
Requip XL	GlaxoSmithKline	Ropinirole hydrochloride XR	Dr. Reddy's Laboratories	Treatment for Parkinson's disease	Jun. 7 2012
Exelon	Novartis	Rivastigmine tartrate Capsules	Breckenridge Pharmaceutical	Treatment of mild to moderate dementia of the Alzheimer's type, and for the treatment of mild to moderate dementia associated with Parkinson's disease	Jun. 14 2012
Exelon	Novartis	Rivastigmine tartrate capsules	Alembic Pharmaceuticals	Treatment of mild to moderate dementia of the Alzheimer's type, and for the treatment of mild to moderate dementia associated with Parkinson's disease	Jun. 14 2012
Symbyax	Lilly USA	Olanzapine/fluoxetine	Teva	Treatment-resistant depression and bipolar I depression	Jun. 21, 2012
Duac Gel	Stiefel Laboratories	Clindamycin phosphate and benzoyl peroxide 1.2%/5% topical gel	Perrigo	Topical treatment of inflammatory acne vulgaris	Jun. 27 2012
Thiamine Hydrochloride		Thiamine hydrochloride	Mylan	Thiamine deficiency	Jun. 28 2012
Boniva	Roche	Ibandronate	Dr. Reddy's Laboratories	Treatment of osteoporosis in women after menopause	Jun. 29 2012