Lupin has launched Raltegravir Tablets USP, 600 mg in the United States following the approval from the U.S. FDA for its Abbreviated New Drug Application. Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD) Isentress HD Tablets, 600 mg of Merck Sharp & Dohme, LLC. and indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity.
Raltegravir Tablets USP, 600 mg (RLD Isentress HD) had an estimated annual sale of $26 million in the U.S.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
