Lupin gets tentative USFDA nod for HIV drug

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-09-24 11:46 GMT | Update On 2025-09-24 11:46 GMT

Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.

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

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc..

The product is indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg.

As per WHO, HIV remains one of the world's most significant public health challenges, particularly in low- and middle-income countries. An estimated 31.6 million people were receiving HIV treatment in 2024.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy) had estimated annual sales of USD 16,237 million in the U.S. (IQVIA MAT July 2025).

Read also: Lupin Manufacturing Solutions: Empagliflozin API gets CADIFA approval from ANVISA, Brazil

In May, Lupin received USFDA approval for the Company's Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. 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.

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.

Read also: Lupin Secures CDSCO Panel Nod for Phase IV Trial of Budesonide-Based COPD Inhaler

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Lupin gets tentative USFDA nod for HIV drug

Similar News

SC Quashes Substandard Rabeprazole Case Against Indica Labs, Cites Limitation Bar

NPPA Revises Ceiling Prices of Essential Drugs Including Riboflavin, Dialysis Solutions, Others; Details

NIT Rourkela Patents Pumpkin Petal-Silk Protein Formulation for Skin Cancer Treatment

CDSCO Panel Asks Astellas Pharma to Update Enzalutamide Label After Phase IV Study

Pfizer to buy obesity drug maker Metsera

Intas Pharma Told to Revise Phase I, III Pembrolizumab Trial Protocol

Sanofi SAR446268 wins USFDA fast track designation for non-congenital myotonic dystrophy type 1