Lupin has announced the launch of Raltegravir Tablets USP, 600 mg in the United States, following approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).
Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD), Isentress® HD Tablets, 600 mg, of Merck Sharp & Dohme, LLC. The product is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adult patients and paediatric 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 estimated annual sales of USD 26 million in the US, according to IQVIA MAT September 2026