Generic Launches

Fall 2020

Robins Kaplan 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
Prolixin Bristol-Myers Squibb fluphenazine Amneal Used to treat schizophrenia 7/10/2020
Nicorette Lozenges Glaxo nicotine polacrilex Dr. Reddy's Used to aid in smoking cessation in adults 7/14/2020
Cubicin Merck daptomycin Sandoz Used to treat adult patients with complicated skin and skin structure infections 7/13/2020
Mexitil Boehringer Ingelheim mexiletine Lannett Used to treat documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening 7/23/2020
Cyklokapron ANI tranexamic acid Apotex Used to treat cyclic heavy menstrual bleeding 7/29/2020
Zyclara Bausch & Lomb imiquimod Teva Used topically to treat clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults; the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older 7/30/2020
Levo-T Cediprof levothyroxine sodium Lannett Used to treat an underactive thyroid gland (hypothyroidism) 8/3/2020
Canasa Allergan mesalamine Camber Used to treat a certain bowel disease (ulcerative colitis) 8/3/2020
Ciprodex Novartis ciprofloxacin / dexamethasone Dr. Reddy's Used to treat infections
caused by susceptible isolates of the designated microorganisms in the
specific conditions Acute Otitis Media in pediatric patients and Acute Otitis Externa
8/11/2020
Yaz Bayer drospirenone / ethyl estradiol Camber Used as a contraception to prevent pregnancy 8/11/2020
Zyflo CR Chiesi zileuton Lupin Used for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older 8/11/2020
Effexor XR Pfizer venlafaxine Hetero Used to treat major depressive disorder, anxiety and panic disorder 8/13/2020
Tecfidera Biogen dimethyl fumarate Mylan Used to treat relapsing forms of multiple sclerosis (MS) 8/19/2020
Revatio Pfizer sildenafil Teva Used to treat erectile dysfunction (impotence) in men 8/19/2020
Rapaflo Allergan silodosin Hetero Used to treat the signs and symptoms of Benign Prostatic Hyperplasia (BPH) 8/21/2020
Cuprimine Bausch & Lomb penicillamine 250mg capsules Dr. Reddy's Used to 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 8/27/2020
Cleocin T gel Pfizer clindamycin Solaris Used topically to treat acne vulgaris in patients 12 years or older 8/31/2020
MoviPrep Bausch & Lomb PEG-3350 / sodium sulfate / sodium chloride / potassium / sodium ascorbate Teva Used to cleanse the colon as a preparation for colonoscopy in adults 8/31/2020
Concerta Johnson & Johnson methylphenidate Dr. Reddy's Used to treat Attention Deficit Hyperactivity Disorder (ADHD) 9/3/2020
Arava Sanofi leflunomide Lupin Used to treat adults with active rheumatoid arthritis (RA) 9/2/2020
Bafiertam Banner monomethyl fumarate Banner Used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease 9/3/2020
Voltaren gel Glaxo diclofenac Perrigo Used to relieve pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands 9/8/2020
Voltaren gel Glaxo diclofenac Dr. Reddy's Used to relieve pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands 9/9/2020
Bethkis Chiesi tobramycin Teva Used to manage cystic fibrosis patients with P. aeruginosa 9/15/2020
Pataday Novartis olopatadine Dr. Reddy's Used to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander 9/17/2020
Depakote ER AbbVie divalproex Lupin Used to treat manic or mixed episodes associated with bipolar disorder, with or without psychotic features; monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures; Prophylaxis of migraine headaches 9/22/2020
Tecfidera Biogen dimethyl fumarate Camber Used to treat relapsing forms of multiple sclerosis 9/24/2020
Tecfidera Biogen dimethyl fumarate Cipla Used to treat relapsing forms of multiple sclerosis 9/25/2020
Precedex Hospira dexmedetomidine Dr. Reddy's Used for sedation of non-intubated patients prior to and/or during surgical and other procedures 9/25/2020
Tecfidera Biogen dimethyl fumarate Dr. Reddy's Used to treat relapsing forms of multiple sclerosis 9/26/2020
Ferriprox Chiesi deferiprone Taro Used to treat patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate 9/28/2020
Tecfidera Biogen dimethyl fumarate Teva Used to treat relapsing forms of multiple sclerosis 9/28/2020
Tykerb Glaxo lapatinib Lupin Used to treat advanced hormone-related breast cancer that has progressed or spread after treatment with other cancer medicines 9/30/2020

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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