Generic Launches

Winter 2016

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Cerebyx Injection	Pfizer	Fosphenytoin Sodium Injection	Amneal	indicated for the control of generalized tonic-clonic epilepsy and the prevention and treatment of seizures occurring during neurosurgery	10/6/2016
Lamictal ODT	GSK	Lamotrigine Orally Disintegrating Tablets	Dr. Reddy's Labs	treatment of certain types of seizures in epileptic patients	10/10/2016
Merrem	AztraZeneca	Meropenem for Injection	Amneal	treatment for intra-abdominal infections and bacterial meningitis	10/12/2016
Beyaz	Bayer	Rajani	Teva	oral contraceptive	10/12/2016
Abilify	Otsuka	Aripiprazole Tablets	Dr. Reddy's Labs	used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression)	10/13/2016
Vagifem	Novo Nordisk	Yuvafem	Amneal	used after menopause to treat menopausal changes in and around the vagina	10/18/2016
Benicar	Daiichi Sankyo	Olmesartan Medoxomil Tablets	Mylan	indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure	10/26/2016
Benicar HCT	Daiichi Sankyo	Olmesartan Medoxomil / Hydrochlorothiazide Tablets	Mylan	indicated for treatment of hypertension to lower blood pressure, and are not indicated for the initial therapy of hypertension	10/26/2016
Entocort EC	Perrigo	Budesonide Extended Release Capsules	Mayne Pharma	used as treatment for patients with mild to moderate Crohn's disease	10/27/2016
Benicar	Daiichi Sankyo	Olmesartan Medoxomil Tablets	Sun Pharm	indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure	10/27/2016
Benicar HCT	Daiichi Sankyo	Olmesartan Medoxomil / Hydrochlorothiazide Tablets	Sun Pharm	indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure	10/27/2016
Azor	Daiichi Sankyo	Amlodipine Besylate / Olmesartan Medoxomil Tablets	Sun Pharm	used to treat high blood pressure (hypertension)	10/27/2016
Tribenzor	Daiichi Sankyo	Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil Tablets	Sun Pharm	used to treat high blood pressure (hypertension)	10/27/2016
Crestor	AstraZeneca	Rosuvastatin Tablets	Camber Pharms	used to treat high cholesterol and triglyceride levels	10/31/2016
Seroquel XR	AstraZeneca	Quetiapine Fumarate Extended Release (ER) Tablets	Endo	add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and schizophrenia	11/1/2016
Azor	Daiichi Sankyo	Amlodipine Besylate / Olmesartan Medoxomil Tablets	Ajanta	used to treat high blood pressure (hypertension)	11/2/2016
Avodart	GlaxoSmithKline	Dutasteride Capsules	Camber Pharms	used to treat enlarged prostrate	11/3/2016
Levaquin	Ortho-McNeil-Janssen	Levofloxacin Tablets	Camber Pharms	used to treat a variety of bacterial infections	11/3/2016
MS Contin	Purdue Pharma	Morphine Sulfate Extended-Release Tablets	Mayne Pharma	an opioid analgesic for moderate to severe pain management	11/3/2016
Angiomax	The Medicines Company	Bivalirudin for Injection	Fresenius Kabi USA	used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty	11/7/2016
Tribenzor	Daiichi Sankyo	Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil Tablets	Teva	indicated for treatment of hypertension, to lower blood pressure	11/7/2016
Azor	Daiichi Sankyo	Amlodipine Besylate / Olmesartan Medoxomil Tablets	Teva	indicated for treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure	11/7/2016
Methergine	Edison Therapeutics	Methylergonovine Maleate Injection	Breckenridge / Ergoject	used for the prevention and control of postpartum hemorrhage	11/9/2016
Evista	Eli Lilly	Raloxifene Hydrochloride Tablets	Dr. Reddy's Labs	prevention and treatment of osteoporosis	11/11/2016
Ditropan XL	Janssen	Oxybutynin Chloride Extended-Release Tablets	Aceto	used in the treatment of overactive bladder	11/14/2016
Activella	Amneal	Amabelz Tablets	Lupin	indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis	11/15/2016
Abilify	Otsuka	Aripiprazole Tablets	Ajanta	used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression)	11/16/2016
Benzamycin Gel	Valeant	Erythromycin / Benzoyl Peroxide Topical Gel	Aceto	used in treatment of acne vulgaris	11/17/2016
Temodar	Merck Sharp & Dohme	Temozolomide Capsules	Mayne Pharma	indicated for the treatment of adult patients with newly diagnosed cancerous brain tumors known as glioblastoma multiform concomitantly with radiotherapy and then as maintenance treatment	11/21/2016
Nuvigil	Cephalon	Armodafinil Tablets	Breckenridge / Natco	indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD)	11/28/2016
Nystatin and Triamcinolone Acetonide Cream	Taro Pharms	Nystatin / Triamcinolone Acetonide Cream	Dr. Reddy's Labs	used to treat fungal skin infections	12/5/2016
Tygacil	Pfizer	Tigecycline for Injection	Fresenius Kabi USA	tetracycline class antibacterial indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections; complicated intra-abdominal infections; and community acquired bacterial pneumonia	12/5/2016
CellCept	Hoffman-LaRoche	Mycophenolate Mofetil Hydrochloride for Injection	Endo	indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney, heart, or liver transplants	12/6/2016
Vancocin	ViroPharma	Vancomycin HCI Capsules	ANI Pharms	indicated for treatment of C. difficile-associated diarrhea	12/10/2016
Tamiflu	Hoffman-LaRoche	Oseltamivir Phosphate Capsules	Alvogen	used to treat the flu (influenza)	12/12/2016
Zetia	Merck	Ezetimibe Tablets	Endo / Glenmark	indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia	12/12/2016
Zetia	Merck	Ezetimibe Tablets	Endo / Glenmark	indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol	12/12/2016
EpiPen Auto-Injector	Mylan	Epinephrine Injection	Mylan	emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens	12/16/2016
Vfend	PF Prism	Voriconazole Tablets / Voriconazole Oral Suspension	Lupin	indicated for use in patients 12 years of age and older in the treatment of fungal infections	12/19/2016
Lithobid	Noven Pharms	Lithium Carbonate Extended Release Tablets	ANI Pharms	used in the treatment of manic episodes of Bipolar Disorder, Manic (DSM-IV)	12/21/2016
Kadian	Allergan	Morphine Sulfate Extended Release Tablets	Impax Labs	indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate	12/22/2016
Zovia 1/50E-28 Tablets	Watson	Ethynodiol Diacetate / Ethinyl Estradiol Tablets	Mylan	indicated for use by women to prevent pregnancy	12/28/2016
Cerebyx	Pfizer	Fosphenytoin Sodium Injection	Mylan	treatment of certain types of severe seizures	12/29/2016
Concerta	Janssen	Methylphenidate Hydrochloride Extended-Release Tablets	Mylan	treatment of Attention Deficit Hyperactivity Disorder (ADHD)	12/29/2016

GENERICally Speaking Winter 2016

Oren D. Langer

Partner

Managing Partner, New York Office

Miles A. Finn, Ph.D.

Counsel

Jeffrey Alan Hovden

Partner

Ryan M. Schultz