Merck Sharp & Dohme

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.