Lupin wins USFDA okay for HIV-1 drug Raltegravir
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (USFDA) has approved the Company's 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.
As per the company, 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 USD 34 million in the U.S. (IQVIA MAT March 2025).
Mdical Dialogues team had earlier reported that the company had received approval from the USFDA for its ANDA for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg. The approval granted for marketing of a generic equivalent of Descovy Tablets, 200 mg/25 mg of Gilead Sciences, Inc.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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