Generic Launches

Summer 2017

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Avodart	GlaxoSmithKline	Dutasteride Soft Gelatin Capsules	Marksans	Indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.	4/7/2017
Nasonex	Merck Sharp Dohme	Mometasone Furoate Monohydrate Nasal Spray	Amneal	Indicated to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itching, and sneezing).	4/11/2017
Lozol	Aventis	Indapamide Tablets	ANI	Indicated for treatment of hypertension and swelling associated with congestive heart failure.	4/19/2017
Prometrium	AbbVie	Progesterone Capsules	Dr. Reddy's	Indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.	4/21/2017
Vytorin	Merck Sharp & Dohme	Ezetimibe / Simvastatin	Impax	Indicated for the treatment of high cholesterol.	4/26/2017
Vytorin	Merck Sharp & Dohme	Ezetimibe / Simvastatin	Teva	Indicated, along with diet, to lower the level of "bad" cholesterol; increase the level of "good" cholesterol; and lower the level of fat in blood.	4/26/2017
Benicar	Daiichi Sankyo	Olmesartan Medoxomil Tablets	Aurobindo	Indicated for treatment of hypertension.	5/1/2017
Benicar HCT	Daiichi Sankyo	Olmesartan Medoxomil / Hydrochlorothiazide Tablets	Aurobindo	Indicated for treatment of hypertension.	5/1/2017
Glumetza	Valeant	Metformin Hydrochloride ER Tablets	Teva	Indicated, along with diet and exercise, to help control high blood sugar in adults with type 2 diabetes mellitus.	5/15/2017
Clolar	Genzyme	Clofarabine Injection	Fresenius Kabi USA	Indicated for treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regiments.	5/16/2017
Doxil	ALZA	Doxorubicin Hydrochloride Liposome Injection	Dr. Reddy's	Indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy; treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.	5/17/2017
Edecrin	Aton	Ethacrynic Acid Tablets	West-Ward Pharmaceuticals	Indicated for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required.	5/17/2017
Azor	Daiichi Sankyo	Amlodipine / Olmesartan Medoxomil Tablets	Aurobindo	Indicated for treatment of hypertension.	5/22/2017
Namenda	Forest Labs	Memantine Hydrochloride Tablets	Strides	Indicated for treatment of moderate to severe Alzheimer-type dementia.	5/24/2017
Strattera	Eli Lilly	Atomoxetine Capsules	Aceto	Indicated for treatment of Attention-Deficit Hyperactivity Disorder.	5/31/2017
Motrin IB (OTC)	Johnson and Johnson	Ibuprofen Tablets (marketed under OTC brand Nuprin)	Strides	Indicated for the treatment of pain relief from various conditions such as headache, dental pain, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.	6/1/2017
Azilect	Teva	Rasagiline Tablets	Mylan	Indicated for treatment of Parkinson's disease.	6/2/2017
Reclast	Novartis	Zoledronic Acid Injection	Mylan	Indicated for the treatment of Paget's disease of bone in men and women.	6/2/2017
Angiomax	The Medicines Company	Bivalirudin for Injection	Dr. Reddy's	Indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.	6/6/2017
Pataday	Novartis	Olopatadine Hydrochloride Ophthalmic Solution 0.2%	Teva	Indicated for treatment of ocular itching associated with allergic conjunctivitis.	6/9/2017
Percocet	Vintage	Oxycodone / Acetaminophen Tablets	Camber	Indicated for treatment of moderate to moderately severe pain.	6/12/2017
Norpramin	U.S. Pharmaceutical Holdings II	Desipramine IR Tablets	Heritage	Indicated for the treatment of depression.	6/12/2017
Pataday	Alcon	Olopatadine Hydrochloride Ophthalmic Solution 0.2%	Sandoz	Indicated for treatment of ocular itching associated with allergic conjunctivitis.	6/12/2017
Zetia	Merck Sharp & Dohme	Ezetimibe Tablets	Teva	Indicated to lower levels of total cholesterol and low-density lipoprotein cholesterol in the blood.	6/12/2017
Zetia	Merck Sharp & Dohme	Ezetimibe Tablets	Amneal	Indicated to lower levels of total cholesterol and low-density lipoprotein cholesterol in the blood.	6/15/2017
Wellbutrin XL Tablets	Valeant	Bupropion Hydrochloride ER Tablets	Lupin	Indicated for the treatment of Major Depressive Disorder and prevention of Seasonal Affective Disorder in adults.	6/15/2017
Acticlate	Aqua Pharmaceuticals	Doxycycline Hyclate IR Tablets	Mayne	Indicated for treatment of a number of infections, including adjunctive therapy in severe acne.	6/15/2017
Hycodan	Endo	Hydrocodone Bitartrate / Homatropine Methylbromide Oral Solution	Perrigo	Indicated for the symptomatic relief of cough in adults and children 6 years of age and older.	6/19/2017
Glucotrol XL	Pfizer	Elipizide ER Tablets	Aceto	Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.	6/20/2017
Micardis	Boehringer Ingelheim	Telmisartan Tablets	Camber	Indicated to treat high blood pressure (hypertension).	6/21/2017
Derma-Smoothe/FS Scalp Oil / Derma-Smoothe/FS Body Oil	Hill Laboratories	Fluocinolone Acetonide Scalp Oil / Fluocinolone Acetonide Topical Oil, 0.01%	Perrigo	Indicated for the topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to four weeks.	6/21/2017
Topicort	Taro	Desoximetasone Cream USP, 0.05% / Desoximetasone Cream USP, 0.25%	Lupin	Indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.	6/22/2017

GENERICally Speaking Summer 2017

Oren D. Langer

Partner

Managing Partner, New York Office

Miles A. Finn, Ph.D.

Counsel

Jeffrey Alan Hovden

Partner

Ryan M. Schultz