Generic Launches

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

Fall 2015

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Aggrenox	Boehringer Ingelheim	Aspirin / Extended-Release Dipyridamole Capsules	Teva	reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis	7/1/2015
Axert	Janssen	Almotriptan Malate Tablets	Teva	acute treatment of migraine attacks in adults with a history of migraine with or without aura; acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more	7/8/2015
Targretin	Valeant	Bexarotene	Mylan	treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy	7/9/2015
Namenda	Forest Labs	Memantine Hydrochloride Tablets	Amneal Pharms	treatment of moderate to severe dementia of the Alzheimer's type	7/11/2015
Namenda	Merz Pharma	Memantine Hydrochloride Tablets	Dr. Reddy's Labs	treatment of moderate to severe dementia of the Alzheimer's type	7/12/2015
Tobi	Novartis	Tobramycin Inhalation Solution	Amneal Pharms	for the management of cystic fibrosis patients with Pseudomonas aeruginosa	7/13/2015
Namenda	Forest Labs	Memantine Hydrochloride Tablets	Mylan	treatment of moderate to severe dementia of the Alzheimer's type	7/14/2015
Angiomax	The Medicines Company	Bivalirudin for Injection	Hospira	indicated as an anticoagulant	7/16/2015
Pulmicort	AstraZeneca	Budesonide Inhalation Suspension	Sandoz	indicated for maintenance treatment of asthma and as a prophylactic therapy in children 12 months to 8 years of age	7/28/2015
Megace ES	E. R. Squibb & Sons	Megestrol Acetate, USP, Oral Suspension	Par Pharm	indicated for the treatment of anorexia, cachexia, or an unexplained significant weigh loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)	7/29/2015
Sodium Edecrin	Alton Pharma	Ethrynate Sodium for Injection USP	Par Pharm	treatment of edema	8/4/2015
Nexium	AstraZeneca	Esomeprazole Magnesium Delayed-Release Capsules	Mylan	treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older	8/5/2015
Lidoderm	Endo Pharm	Lidocaine Patch 5%	Mylan	indicated for relief of pain associated with post-herpetic neuralgia	8/10/2015
Mirapex ER	Boehringer Ingelheim	Pramipexole Dihydrochloride ER Tablets	Dr. Reddy's Labs	treatment for Parkinson's disease	8/11/2015
Xenazine	Valeant	Tetrabenazine	Sun Pharm	treatment of chorea associated with Huntington’s disease.	8/17/2015
Abilify	Bristol-Myers Squibb	Aripiprazole Oral Solution	Amneal Pharms	add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age.	8/18/2015
Abilify	Bristol-Myers Squibb	Aripiprazole Oral Solution	Silarx Pharms	add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age.	8/18/2015
Yaz	Bayer HealthCare	Drospirenone / Ethinyl Estradiol Tablets	Glenmark Pharms	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	8/19/2015
Zosyn	Pfizer	Piperacillin / Tazobactam for Injection	Mylan	indicated for treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria	8/25/2015
Dibenzyline	WellSpring Pharms	Phenoxybenzamine Hydrochloride Capsules	Roxane Labs	treating high blood pressure and sweating caused by a certain kind of tumor (pheochromocytoma)	8/25/2015
Exelon	Novartis	Rivastigmine Transdermal System	Alvogen	treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease.	8/31/2015
Exelon	Novartis	Rivastigmine Transdermal System	Sandoz	treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease.	8/31/2015
Cymbalta DR	Eli Lilly and Co.	Duloxetine DR Capsules	Lupin	Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathic Pain; Chronic Musculoskeletal Pain	9/3/2015
Vfend	PF Prism	Voriconazole Tablets	Glenmark Pharms	treating certain fungal infections	9/4/2015
Yasmin	Bayer	Drospirenone / Ethinyl Estradiol Tablets	Mylan	indicated for use by women to prevent pregnancy	9/8/2015
Unasyn	Pfizer	Ampicillin / Sulbactam for Injection	Mylan	indicated for the treatment of infections due to susceptible strains of designated microorganisms in skin and skin structure infections, intra-abdominal infections and gynecological infections	9/14/2015
Lescol XL	Novartis	Fluvastatin Sodium ER Tablets	Mylan	indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride and increase HDL-C in adults with primary hypercholesterolemia and mixed dyslipidemia	9/18/2015
BenzaClin	Valeant	Phosphate 1% / Benzoyl Peroxide 5%	Perrigo	indicated for the topical treatment of acne vulgaris	9/22/2015
Invega	Janssen	Paliperidone ER Tablets	Allergan	treatment of schizophrenia in adults and adolescents (12-17 years of age)	9/25/2015
Invega	Janssen	Paliperidone ER Tablets	Patriot Pharm	treatment of schizophrenia in adults and adolescents (12-17 years of age)	9/25/2015
Nexium	AstraZeneca	Esomeprazole Magnesium DR Capsules	Dr. Reddy's Labs	treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older	9/28/2015
Invega	Janssen	Paliperidone ER Tablets	Mylan	treatment of schizophrenia in adults and adolescents (12-17 years of age) in addition to schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants in adults	9/28/2015
Orap	Teva	Pimozide	Par Pharm	antipsychotic indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment	9/30/2015