Generic Launches

Summer 2016

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Femhrt	Warner Chilcott	Norethindrone Acetate and Ethinyl Estradiol Tablets	Lupin	indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis	4/5/2016
Epivir	ViiV Healthcare	Lamivudine Tablets	Mylan	indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection	4/6/2016
Lopressor	Novartis	Metoprolol Tartrate Tablets	Mylan	indicated for the treatment of hypertension	4/11/2016
Glucerna Asceptic Adult Nutritional Shake (OTC)	Abbott Laboratories	Glucerna Asceptic Adult Nutritional Shake (OTC)	Perrigo	nutritional shake for people with diabetes	4/12/2016
Zyvox	Pfizer	Linezolid Injection in Freeflex bags	Fresenius Kabi USA	indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial and Community-acquired pneumonia, Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, Uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecium infections	4/21/2016
BenzaClin Pump Topical Gel	Valeant Pharmaceutical	Clindamycin Phosphate 1% / Benzoyl Peroxide 5%	Perrigo	indicated for the topical treatment of acne vulgaris	5/2/2016
Mucinex DM ER Tablets (OTC)	Reckitt Benckiser	Guaifenesin / Dextromethorphan Hydrobromide ER Tablets (OTC)	Perrigo	indicated to control coughs and to break up mucus, making coughs more productive	5/3/2016
Apresoline	Novartis	Hydralazine Hydrochloride Injection	Mylan	treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure	5/5/2016
Lipofen	Cipher Pharmaceuticals	Fenofibrate Capsules	ANI Pharmaceuticals	indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia	5/9/2016
Frova	Endo Pharms	Frovatriptan Succinate Tablets	Mylan	treat acute migraine headaches in adults	5/12/2016
Rowasa	Alaven Pharmaceuticals	Mesalamine rectal suspension enema	ANI Pharmaceuticals Inc.	indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis	5/16/2016
Apresazide	Novartis	Hydralazine Hydrochloride Injection	Mylan	indicated for treatment of severe essential hypertension when the oral version of the drug cannot be given and there is in urgent need to lower blood pressure	5/16/2016
Doryx	Mayne	Doxycycline Hyclate Delayed-Release (DR) Tablets, 200 mg.	Mylan	indicated as adjunctive therapy for severe acne	5/23/2016
Flonase (OTC)	GlaxoSmithKline	Fluticasone 50 MCG Spray (OTC)	Hikma	indicated for the temporary relief of hay fever or for the upper respiratory allergies in adult and pediatric patients 4 years of age and older	5/31/2016
Flonase (OTC)	GlaxoSmithKline	Fluticasone Propionate Nasal Spray (OTC)	Perrigo	indicated for the temporary relief of hay fever or other upper respiratory allergies in adult and pediatric patients 4 years of age and older	5/31/2016
Doxteric	Mayne	Doxycycline Hyclate Delayed-Release (DR) Tablets, 50 mg.	Mylan	indicated as adjunctive therapy for severe acne	6/1/2016
Nuvigil	Cephalon	Armodafinil Tablets	Mylan	used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift-work disorder	6/1/2016
Rythmol SR	GlaxoSmithKline	Propafenone Hydrochloride ER Capsules	Mylan	indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease	6/2/2016
Vidaza	Celgene	Azacitidine for Injection	Mylan	indicated for the treatment of the five French-American-British (FAB) subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia	6/2/2016
Cleocin	Pharmacia and Upjohn	Clindamycin Palmitate Hydrochloride for Oral Solution	Mylan	indicated for treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives are inappropriate	6/3/2016
OxyIR	Purdue Pharma	Oxycodone HCI Capsules	ANI Pharmaceuticals	indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate	6/13/2016
Namenda	Forest Laboratories	Memantine Hydrochloride Tablets	Ajanta Pharma	anti-dementia drug	6/14/2016
Avodart	GlaxoSmithKline	Dutasteride Capsules	Mylan	indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery	6/24/2016
Imitrex	GlaxoSmithKline	Sumatriptan Injection	Teva / Antares Pharma	treat acute migraine with or without aura, and acute cluster headaches in adults	6/27/2016
Lutera 28	Alesse	Larissia	Amneal Pharmaceuticals	oral contraception	6/29/2016

GENERICally Speaking Summer 2016

First Quarter

ANDA Litigation Settlements