MUMBAI – – November 03, 2026 -- Lupin Limited has launched Raltegravir Tablets USP, 600 mg in the United States and is eligible for 180-day generic drug exclusivity, after the U.S. FDA approved its Abbreviated New Drug Application.

The product is bioequivalent to the reference listed drug Isentress HD Tablets, 600 mg, marketed by Merck Sharp & Dohme, LLC. Lupin is the exclusive first-to-file applicant for the product.

Reference product generated an estimated USD 26 million in annual US sales

Isentress HD 600 mg had estimated annual U.S. sales of USD 26 million, according to IQVIA MAT September 2026 data. That figure is the market the 180-day exclusivity window covers for Lupin.

Tablets are indicated for HIV-1 in adults and pediatric patients of at least 40 kg

The generic is approved for use in combination with other antiretroviral agents. It treats Human Immunodeficiency Virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg.