Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg.
The approval has been granted to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Raltegravir Tablets USP, 600 mg are 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.
Raltegravir Tablets USP, 600 mg (RLD Isentress HD) had an estimated annual sale of USD 36 million in the U.S. (IQVIA MAT September 2024).
