Generic Launches

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

December 29, 2011

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Reference Listed Drug NDA Holder Generic Drug Name ANDA Applicant(s) Indication Launch Date
Lonamin Celltech Pharma, Inc. Phentermine HCL Capsules Lannett Co. Weight loss 10/14/2011
Loxitane capsules Watson Pharma Loxapine capsules Lannett Co. Schizophrenia 10/14/2011
Zyprexa Zydis ODT Eli Lilly Olanzapine (ODT) Apotex Inc, Dr. Reddys Labs, Par Pharma, Torrent Pharms LLC, Proasco Atypical antipsychotics 10/24/2011
Zyprexa Eli Lilly Olanzapine (Tabs) Dr. Reddys Labs., Teva Intramuscular Solution Atypical Antipsychotics 10/24/2011
Tenuate Aventis Pharma. Inc. Diethylpropion tablets Lannett Co. Weight loss 10/24/2011
Elestat Allergan Pharma Epinastine HCL Ophthalmic solution Perrigo/ PharmaForce/Luitpold Pharma Prevention of ocular itching associated with allergic conjunctivitis. 11/1/2011
Xyzal Solution Sanofi Aventis Levocetirizine dihydrochloride Perrigo Co partner w/Synthon Pharms AntihistaminesNon Sedating 11/7/2011
Kadian Actavis Morphine Sulfate Watson/Actavis (authorized generic) Pain Extended Release 11/10/2011
Primaxin Merk Imipenem/cilastatin Hospira Antibiotic 11/16/2011
Lipitor Pfizer Atorvastatin Watson/Pfizer (authorized generic) HMG CoA Reductase Inhibitors 11/29/2011
Cyclokapron Injection Pharmacia & Upjohn Tranexamic acid Injection Mylan Short-term use in patients with Hemophilia to reduce or prevent hemorrhage during and following oral surgery 12/2/2011
Epivir VIIV healthcare - (GSK and Pfizer joint venture) Lamivudine Aurobindo and Apotex HIV-1 12/2/2011
Lipitor/Caduet Pfizer Atorvastatin/amlodipine Ranbaxy/Pfizer, Mylan/Pfizer HMG CoA Reductase Inhibitors, hypertension 12/6/2011
LoSeasonique Teva Amethia Lo (levonorgestrel/ethinyl estradiol) Watson Contraceptive pill 12/7/2011
Dyazide Capsules SmithKline Beecham Triamterene with Hydrochlorothiazide Lannett Co. Antihypertensive drug with a potassium-sparing diuretic 12/12/2011
Toprol-XL Tablets AstraZeneca Metoprolol Succinate Mylan Inc. Hypertension 12/16/2011
Vfend Pfizer Voriconazole tablets Sandoz Infections caused by yeast or other types of fungal infections. 12/20/2011
Teveten Tablets Abbott Laboratories Eprosartan Mesylate Mylan Pharmaceuticals Inc. Hypertension 12/27/2011
Keppra UCB Pharma's Levetiracetam Mylan Inc. Epilepsy 12/27/2011
Combivir GSK Lamivudine and Zidovudine Teva Pharmaceutical HIV-1 12/27/2011

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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