Generic Drug Launches and 505b2 Applications Spring 2021

First Quarter

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