Line design
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
GENERICally Speaking: A Hatch Waxman Litigation Bulletin
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

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