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Lupin has obtained tentative approval from the US FDA for its HIV generic (bictegravir/emtricitabine/tenofovir), to be made at its Nagpur plant. Its rival Biktarvy sells ~$16.2 bn in U.S. Lupin share price fell modestly.
Source: Lupin Press Release (NSE Exchange Fillings) | Published on Sept 25, 2025
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As quoted in the press release of Lupin (NSE Exchange Filings), the company has shared that it has received a tentative approval from the United States Food and Drug Administration (FDA) for its generic formulation of bictegravir, emtricitabine, and tenofovir alafenamide tablets in strengths of 50 mg, 200 mg, and 25 mg. It is for the treatment of HIV infection in adults and in paediatric patients weighing at least 25 kg.
The drug was approved as a generic version of Biktarvy, a well-established treatment for HIV sold by Gilead Sciences Inc. Lupin plans to manufacture the approved tablets at its plant in Nagpur. Industry data estimates that Biktarvy generated approximately USD 16.2 billion in annual sales in the United States for the twelve months ending July 2025.
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Lupin has received tentative FDA approval for a generic HIV treatment.
The drug will be produced at the company’s Nagpur facility.
Biktarvy, the reference drug, reported estimated annual sales of USD 16.2 billion.
Lupin faced four FDA observations during a recent inspection of its Pune facility.
The company also recently gained approval for a drug to treat multiple myeloma.
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The HIV product from Lupin intends to offer a therapeutic alternative in a valuable market. Production at the Nagpur site will allow Lupin to have good supply once regulatory issues are sorted out. Tentative approval indicates the product meets FDA quality and safety standards, but it will be up to Lupin to commercialise it, which will depend on patent expiry and further possible approvals.
Strong sales of the reference product highlight the commercial potential of this market. With global demand for HIV treatments still growing, the approval puts Lupin in line to the market when full clearance is attained.
In early September, Lupin noted that it had received four observations from the FDA after FDA’s product-specific pre-approval inspection of its biotechnology facility in Pune between September 8 and 19. The company said that it will respond to the regulator within the specific time period and is still focused on continuing the compliance with current Good Manufacturing Practices across all facilities.
It also announced FDA gave it approval on September 18 for lenalidomide capsules in strength of 2.5 mg to 25 mg for the treatment of multiple myeloma. The company continues to make progress in building its pipeline and regulatory approvals as part of its long-term strategy.
Lupin share price fell slightly in reaction to the announcement, an effect of market caution in the wake of regulatory updates. As of 24 September 2025, 15:30 PM IST, Lupin share price was at ₹1,991 per share on the BSE.
The change in Lupin share price illustrates how regulatory changes directly impact investor perception. Even if another approved application is a step forward in the company's US generics pipeline, market players may now also start to monitor how the company responds to the observations from the FDA, and how it plans to achieve a commercial launch.
This development is noteworthy because it suggests that Lupin is enhancing its footprint in the US generics space. Focus on a high-value therapeutic category like HIV treatment may help fortify its positioning in regulated markets.
Lupin's update on its Nagpur manufacturing site and updates around regulatory inspections will continue to be the areas to watch for the next few quarters. The stock remains one to watch as updates in these areas may alter the pace of Lupin's growth outlook and its trajectory with respect to overall market performance.
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