Generic Launches

First Quarter

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Amitiza Takeda Lubiprostone Par Used to treat chronic idiopathic constipation, as well as opioid-induced constipation in adult with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation. The drug is also used to treat irritable bowel syndrome with constipation in women at least 18 years old 1/4/2021
Firazyr Takeda icatibant Apotex Used to treat acute attacks of
hereditary angioedema
1/6/2021
Zytiga Johnson & Johnson abiraterone Amneal Used to treat metastatic prostate cancer 1/8/2021
Uloric Takeda febuxostat Dr. Reddy's Labs Used for the chronic
management of hyperuricemia in adult
patients with gout
1/11/2021
Tecfidera Biogen dimethyl fumarate TWi Used to treat relapsing forms of multiple sclerosis 1/11/2021
Albenza Amneal albendazole Cost Plus Used to treat parasitic infections such as hydatid disease and neurocysticercosis 1/14/2021
NuvaRing Merck etonogestrel / ethyl estradiol Teva Used by women to prevent pregnancy 1/14/2021
Effexor XR Wyeth venlafaxine Hetero Used to treat major depressive disorder, anxiety, and panic disorder 1/21/2021
Minipress Pfizer prazosin ANI Used to treat hypertension, to lower blood pressure 2/1/2021
Sabril Lundbeck vigabatrin Dr. Reddy's Labs Used to treat refractory complex partial seizures and infantile spasms 2/2/2021
Thorazine Glaxo chlorpromazine Lannett Used to treat psychotic disorders such as schizophrenia or manic-depression in adults 2/8/2021
AndroGel 1.62% Unimed testosterone Teva Used for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone 2/12/2021
Noxafil Merck posaconazole Lupin Used for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy 2/17/2021
Xeloda Roche capecitabine Dr. Reddy's Labs Used to treat adjuvant colon cancer, metastatic colorectal & breast cancer 2/17/2021
Northera Lundbeck droxidopa Hetero Used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH) 2/19/2021
Prevacid SoluTab Takeda lansoprazole Dr. Reddy's Used to treat certain stomach and esophagus problems (such as acid reflux, ulcers) 2/22/2021
Northera Lundbeck droxidopa Hikma Used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH) 3/2/2021
Depen Mylan penicillamine Lupin Usedto treat Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy 3/2/2021
Azopt Novartis brinzolamide Teva Used to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma 3/8/2021
Alinia Romark nitazoxamide Lupin Used in the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older 3/10/2021
Foscavir Teva foscarnet Fresenius Kabi Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and in Combination therapy with Foscarnet Sodium Injection and ganciclovir for patients who have relapsed after monotherapy with either drug 3/15/2021
Lopid Pfizer gemfibrozil Hetero Used together with proper diet to treat very high cholesterol and triglyceride levels and raise “good” cholesterol (HDL) in the blood 3/30/2021

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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