Archive · 25 Sep 2025
Lupin Gets FDA Nod, Shares Up on HIV Drug Approval
Lupin, an Indian pharmaceutical company, got a tentative approval from the US FDA for a generic version of an HIV treatment drug called Biktarvy.
This means Lupin can start selling its own version of the drug in the US.
The original Biktarvy drug makes billions of dollars each year.
Lupin's stock went up after the announcement.
The generic drug will be made at Lupin's facility in India.
Lupin Ltd received tentative approval from the US FDA for its HIV treatment tablets.
The drug is a generic equivalent of Biktarvy tablets (bictegravir, emtricitabine, and tenofovir alafenamide).
The generic drug will be manufactured at Lupin’s Nagpur facility in India.
Biktarvy, the original drug, recorded $16.24 billion in US sales in 2023.
Lupin's shares rose 2% on Thursday after the announcement.
- Who
- Lupin Ltd, US FDA
- What
- Received tentative approval for its generic HIV drug.
- When
- Thursday's trade
- Where
- US, Nagpur facility in India (manufacturing)
- Why
- To market a generic equivalent of an HIV treatment drug.
- Company
- Lupin Ltd
- Drug Approval
- Tentative FDA approval for HIV treatment tablets
- Generic Equivalent
- Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
- Original Drug Manufacturer
- Gilead Sciences Inc.
- Annual Sales (Biktarvy - US, 2023)
- $16.24 billion
- Manufacturing Location
- Lupin’s Nagpur facility in India
- Stock Performance
- Up 2% on Thursday, 12 of last 15 sessions gained
Sources
Indian drugmakers Dr Reddy's, Hetero to sell generic HIV prevention drug for $40 a year
HIV-Prevention Drug To Be Available For Rs 3,500 A Year From 2027
Dr Reddy's, Hetero to sell generic HIV prevention drug for $40 a year