Lupin wins USFDA okay for HIV-1 drug Raltegravir

This product will be manufactured at Lupin’s Nagpur facility in India.

Read also: Lupin Launches Ajaduo M Forte, a Triple Fixed-Dose Combination of Empagliflozin, Linagliptin, and Metformin Extended Release (ER)

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.

Read also: BRESER Study Demonstrates Real-World Efficacy and Safety of Lupin's Ranibizumab Biosimilar (Ranieyes)

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.

Read also: Revise study protocol: CDSCO Panels tells Lupin on Ranibizumab Solution for Injection 10 mg/mL