Generic Launches Q4 2012

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

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Reference Listed Drug

NDA Holder

Generic Drug Name

ANDA Applicant(s)


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
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
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
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





Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

Back to Top