Generic Drug Launches and 505b2 Applications Fall 2020

Fall 2020

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

GENERICally Speaking Fall 2020

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

Jeffrey Alan Hovden

Partner

Christopher A. Pinahs

Partner

Kelsey J. McElveen

Associate

GENERICally Speaking Fall 2020

VOL. 10, NO. 3

Third Quarter

ANDA Approvals