Generic Launches Q4 2012

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

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Cafcit	Bedford Labs	Caffeine Citrate Injection,	Sagent Pharmaceuticals	treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age	10/3/2012
Cafcit	Bedford Labs	Caffeine Citrate Oral Solution, USP	Sagent Pharmaceuticals	treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age	10/3/2012
Evoxac	Daiichi Sankyo	Cevimeline Hydrochloride 30 mg. capsules	Ranbaxy Laboratories	treatment of symptoms of dry mouth associated with Sjogren's Syndrome	10/9/2012
Topicort	Taro Pharms North	Desoximetasone Ointment USP, 0.25%	Sandoz	topical steroid: allergic reactions, eczema, and psoriasis	10/10/2012
Avapro	Sanofi	Irbesartan Tablets	Watson Laboratories	hypertension	10/12/2012
Sanctura XR	Allergan	Trospium Chloride Extended-release Capsules	Watson Pharmaceuticals	overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency	10/12/2012
Avapro	Sanofi Aventis	Irbesartan	Roxane Laboratories	hypertension	10/15/2012
Avalide	Sanofi Aventis	Irbesartan / Hydrochlorothiazide	Roxane Laboratories	hypertension	10/15/2012
Optivar	Meda Pharmaceuticals	Azelastine Ophthalmic Solution	Sandoz	antihistamine: itchy eyes	10/23/2012
Seasonale	Teva Branded Pharmaceuticals	Levonorgestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg	Lupin Pharmaceuticals	oral contraceptive	10/25/2012
Actos	Takeda Pharms USA	Pioglitazone Hydrochloride	Watson Pharmaceuticals	type 2 diabetes	10/26/2012
Leucovorin Calcium	Bedford Labs	Leucovorin Calcium for Injection	Sagent Pharmaceuticals	megaloblastic anemias	10/29/2012
Revatio	Pfizer	Sildenafil Tablets	Watson Pharmaceuticals	pulmonary arterial hypertension	11/12/2012
Revatio	Pfizer	Sildenafil Citrate Tablets	Mylan Laboratories	pulmonary arterial hypertension	11/13/2012
Diamox	Teva Women's	Acetazolamide for Injection, USP	Sagent Pharmaceuticals	adjunctive treatment of edema due to congestive heart failure	11/13/2012
Revatio	Pfizer	Sildenafil Citrate Tablets	Dr. Reddy’s Laboratories	pulmonary arterial hypertension	11/16/2012
Tricor	Abbott	Fenofibrate Tablets, 48 mg and 145 mg	Lupin Pharmaceuticals	primary hypercholesterolemia and severe hypertriglyceridemia	11/20/2012
Absorica	Cipher Pharmaceuticals	Isotretinoin	Ranbaxy Laboratories	treatment of severe recalcitrant nodular acne	11/26/2012
Nallpen	Baxter Healthcare	Nafcillin - semisynthetic	Sagent Pharmaceuticals	treatment of infections caused by penicillinase-producing staphylococci	11/28/2012
Detrol	Pharmacia and Upjohn	Tolterodine Tartrate Tablets	Mylan Pharmaceuticals	overactive bladder	11/29/2012
Symbyax	Eli Lilly & Co	Olanzapine / Fluoxetine	Sandoz	depression caused by bipolar disorder	11/30/2012
Atacand HCT	AstraZeneca	Candesartan Cilexetil / Hydrochlorothiazide Tablets	Mylan Pharmaceuticals	hypertension	12/5/2012
Qualaquin	Mutual Pharmaceutical Company	Quinine Sulfate Capsules USP	Mylan Pharmaceuticals	plasmodium falciparum malaria	12/18/2012
Yasmin	Bayer Healthcare	Drospirenone / Ethinyl Estradiol Tablets, 3 mg/0.03 mg	Lupin Pharmaceuticals	oral contraceptive	12/19/2012
Nordette 28	Teva Branded Pharmaceutical Products	Levonorgestrel / Ethinyl Estradiol Tablets USP	Mylan Inc Partner Famy Care (Distributed in the U.S. by Mylan Pharmaceuticals Inc.)	method of contraception	12/28/2012
Dilantin	Pfizer	Phenytoin Chewable Tablets USP	Mylan Pharmaceuticals	prevention and treatment of seizures occurring during or following neurosurgery	12/28/2012

GENERICally Speaking Winter 2012

Jeffrey Alan Hovden

Partner

Oren D. Langer

Partner

Managing Partner, New York Office

Ryan M. Schultz