Lupin gets US FDA nod for HIV drug

Business Sep 24, 2025

Lupin just received tentative approval from the US FDA for its generic version of a major HIV drug, aimed at adults and kids over 25kg.
This new medicine is a take on Gilead's Biktarvy and will be made in Nagpur.
Even with this win, Lupin's shares dipped slightly by 0.80% to ₹1,991 on Wednesday.

Biktarvy pulled in $16.2 billion in US sales

Biktarvy pulled in $16.2 billion in US sales over the past year, so Lupin's entry could be huge.
Meanwhile, their Pune plant was recently inspected by the FDA—they got four observations and say they'll fix them on time.
Just last week, Lupin also scored another FDA approval for a cancer drug used in multiple myeloma.