Generic Pharmaceutical Launches Spring 2020 | Hatch-Waxman

Spring 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
Neoral	Novartis	cyclosporine	Apotex	used for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants	1/3/2020
Silenor	Currax	doxepin	Teva	used to treat insomnia characterized by difficulty with sleep maintenance	1/3/2020
NovoLog/NovoLog Mix	Novo-Nordisk	insulin aspart recombinant	N/A	used to lower blood glucose	1/7/2020
Symbicort	Astra-Zeneca	budesonide / formoterol	Prasco	used as a maintenance treatment in chronic obstructive pulmonary disease (COPD)	1/8/2020
NovoLog/NovoLog Mix	Novo-Nordisk	insulin aspart protamine	N/A	used to lower blood glucose	1/21/2020
Carafate	Allergan	sucralfate	Endo	used to treat and prevent ulcers in the intestines	1/27/2020
Clobex	Micro/Saptalis	clobetasol	N/A	used to treat psoriasis and dermatitis	1/24/2020
Absorica LD	Sun	isotretinoin	N/A	used for the management of severe recalcitrant nodular acne in patients 12 years of age and older	2/4/2020
Syprine	Bausch & Lomb	trientine HCl	Dr. Reddy's	used to treat patients with Wilson's disease who are intolerant of penicillamine	2/7/2020
Marinol	AbbVie	dronabinol	Hetero (Camber)	used to treat nausea and vomiting caused by cancer chemotherapy; also used to treat loss of appetite and weight loss in people with HIV infection	2/11/2020
Moxeza	Novartis	moxifloxacin	Lupin	used to treat conjunctivitis caused by susceptible strains of certain organisms	2/14/2020
Nexium	Astra-Zeneca	esomeprazole magnesium	Hetero (Camber)	used to treat heartburn, gastroesophageal reflux disease (GERD), stomach ulcers, and a damaged esophagus	2/20/2020
Vimovo	Horizon	naproxen / esomeprazole	Dr. Reddy's	used for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers	2/27/2020
Vimovo	Horizon	naproxen / esomeprazole	Lupin	used for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers	3/5/2020
Geodon	Pfizer	ziprasidone	Dr. Reddy's	used to treat occurrences of severe agitation in patients with schizophrenia	3/17/2020
Daraprim	Vyera	pyrimethamine	Dr. Reddy's	used to treat toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination	3/20/2020
Lyrica	Pfizer	pregabalin	Hetero (Camber)	used to treat pain caused by nerve damage due to diabetes or shingles infection	3/24/2020
Adderall XR	Shire	dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate	Lannett	used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy	3/31/2020