Generic Launches

Spring 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
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
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