Lupin Secures Tentative U.S. FDA Approval For Generic HIV Drug Raltegravir

Global pharmaceutical company Lupin Limited has announced that it received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. This approval allows Lupin to market a generic equivalent of Merck Sharp & Dohme’s Isentress HD Tablets, 600 mg, which are used in HIV-1 treatment.

Lupin holds the exclusive first-to-file status for this product, positioning it to potentially gain 180 days of market exclusivity in the United States. The Raltegravir Tablets USP, 600 mg will be produced at Lupin's Nagpur facility in India.

The approved Raltegravir Tablets are intended for use in combination with other antiretroviral agents to treat HIV-1 infection in both adult patients and pediatric patients weighing at least 40 kg. The brand-name equivalent, Isentress HD, recorded annual U.S. sales of approximately USD 36 million, according to IQVIA MAT data for September 2024.