Lupin Ltd, one of India’s leading pharmaceutical companies, has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (50 mg/200 mg/25 mg), used in the treatment of human immunodeficiency virus (HIV) infection.
The approval, granted under the Abbreviated New Drug Application (ANDA) pathway, allows Lupin to manufacture the generic version at its Nagpur facility. The tablets are bioequivalent to Gilead Sciences’ Biktarvy, catering to adults and pediatric patients weighing at least 25 kg.
According to IQVIA MAT July 2025 data, Biktarvy tablets have estimated annual US sales of $16.24 billion, highlighting the commercial significance of Lupin’s approval in the world’s largest pharmaceutical market.
This milestone strengthens Lupin’s HIV portfolio in the US, one of its key international markets, and aligns with the company’s ongoing strategy to expand access to high-value, high-impact therapies globally.
✅ Summary
- Company: Lupin Ltd
- Approval: Tentative USFDA approval for generic Bictegravir/Emtricitabine/Tenofovir Alafenamide tablets (50/200/25 mg)
- Manufacturing: Nagpur facility, India
- Reference Product: Biktarvy by Gilead Sciences
- Market Potential: $16.24 billion US annual sales
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