Print

Generic Launches

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

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.