Lupin bags tentative USFDA nod for Raltegravir Tablets for HIV-1 infection
Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day 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 36 million in the U.S. (IQVIA MAT September 2024).
Read also: Lupin Gets CDSCO Panel Nod to Study Antidiabetic FDC
Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovy Tablets, 200 mg/25 mg, of Gilead Sciences, Inc.
Read also: Lupin bags tentative USFDA nod for HIV-1 infection drugs
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 has 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.
