Generic Launches

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

Winter 2015

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Reference Listed Drug NDA Holder Generic Drug Name ANDA
Indication Launch Date
Avodart GlaxoSmithKline Dutasteride Capsules Teva indicated for the treatment of the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate 10/12/2015
Lescol XL Novartis Fluvastatin Sodium Extended-Release Tablets Sandoz indicated as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease, and reduce the risk of needing procedures to improve blood flow to the heart 10/16/2015
PhosLo Gelcaps Fresenius Medical Care North America Calcium Acetate Capsules Lupin Pharms indicated for control of hyperphosphatemia in end stage of renal failure 10/26/2015
Fusilev Spectrum Pharms Levoleucovorin Calcium Injection Mylan indicated for rescue use after high-dose methotrexate therapy in osteosarcoma; also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists 10/27/2015
Glucotrol XL Pfizer Glipizide Extended-Release Tablets Mylan indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 11/16/2015
Viramune XR Boehringer Ingelheim Nevirapine Extended-Release Tablets Mylan used in combination with other antiretroviral agents for treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age 11/16/2015
Axert Janssen Pharms Almotriptan Tablets Mylan used for the acute treatment of migraine attacks in adult patients with history of migraine with or without aura 11/17/2015
Adderall Teva Dextroamphetamine Saccharate / Amphetamine Aspartate / Dextroamphetamine Sulfate / Amphetamine Sulfate Tablets (mixed salts of a single entity amphetamine product) Mylan indicated for the treatment of attention deficit hyperactivity disorder (ADHD) 11/19/2015
FazaClo ODT Jazz Pharm Clozapine Orally Disintegrating Tablets Mylan treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment 11/24/2015
Zyvox Pfizer Linezolid Tablets Mylan treatment of certain infections caused by susceptible Gram-positive bacteria 12/29/2015



Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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