Shares of Lupin Ltd edged up on Thursday, September 25, trading 1.34% higher at ₹2,017.50 apiece, after the company announced a key regulatory milestone. The global pharma major has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of an HIV treatment.
The product — bictegravir, emtricitabine, and tenofovir alafenamide tablets (50 mg/200 mg/25 mg) — will be manufactured at Lupin’s Nagpur facility. It is the generic equivalent of Biktarvy tablets from Gilead Sciences Inc, prescribed for the treatment of HIV infection in adults and paediatric patients weighing at least 25 kg.
According to IQVIA MAT July 2025, Biktarvy had estimated annual sales of USD 16.2 billion in the US, highlighting the significant market opportunity for Lupin.
The development follows a string of updates from the company. On September 20, Lupin disclosed that the FDA issued four observations after a pre-approval inspection at its biotech facility in Pune. Earlier, on September 18, the company had secured FDA approval for its lenalidomide capsules (2.5 mg to 25 mg), used in the treatment of multiple myeloma.
Shares of Lupin have been trending upward on the back of these regulatory developments, with the latest approval boosting investor sentiment further.
