Lupin Receives Approval from U.S. FDA for Raltegravir Tablets USP, 600 mg; Eligible for 180-day Generic Exclusivity

Global pharma major Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. The product is bioequivalent to Isentress® HD Tablets, 600 mg of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupin’s Nagpur facility in India and is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. Raltegravir Tablets USP, 600 mg (RLD Isentress® HD) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT March 2025).