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Lupin gets USFDA’s nod for Raltegravir Tablets USP, 600 mg
May-08-2025

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.

Raltegravir Tablets USP, 600 mg are 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. Raltegravir Tablets USP, 600 mg (RLD Isentress HD) had an estimated annual sale of $34 million in the U.S. (IQVIA MAT March 2025).  

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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