Lupin launches Raltegravir 600 mg tablets in US with 180-Day exclusivity

Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD) Isentress® HD Tablets, 600 mg of Merck Sharp & Dohme,

Global pharma major Lupin Limited (Lupin) today announced the launch of Raltegravir Tablets USP, 600 mg in the United Statesfollowing the approval from the U.S. FDA for its Abbreviated New Drug Application.

Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD) Isentress® HD Tablets, 600 mg of Merck Sharp & Dohme, LLC. and 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. 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 an estimated annual sale of USD 26 million in the U.S. (IQVIA MAT September 2026).