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Lupin has received tentative approval from the USFDA for its generic version of Symtuza. The drug had annual sales of $1,374 million in the US. Lupin, the exclusive first-to-file applicant, will manufacture it at its Nagpur facility. Shares rose 3.5% to ₹2,103.
Drug manufacturer Lupin has secured tentative approval from the US Food and Drug Administration for its generic version of a combination HIV treatment. The approval covers Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets, marking a crucial step for Lupin in the US market. The drug is therapeutically equivalent to Symtuza, a widely used combination HIV treatment marketed by Janssen Products.
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Lupin secures tentative USFDA approval for a combination HIV treatment.
The generic drug is therapeutically equivalent to Symtuza tablets.
US market sales of the drug reached $1,374 million as per IQVIA MAT December 2024 data.
Lupin is the exclusive first-to-file applicant, gaining a potential advantage in exclusivity.
The product will be manufactured at Lupin’s Nagpur facility in India.
Lupin share price surged 3.5%, closing at ₹2,103 on BSE.
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With an estimated market size of $1,374 million in the US, Lupin’s tentative approval strengthens its position in the HIV drug segment. The company’s status as the exclusive first-to-file applicant enhances its competitive standing, as it could benefit from potential exclusivity upon final approval. This move also aligns with Lupin’s strategy to expand its presence in the US generics market.
The product’s manufacturing at Lupin’s Nagpur facility highlights the company’s growing capabilities in producing complex formulations. This approval positions Lupin for higher market penetration once the final approval is granted.
Following the announcement, Lupin share price surged 3.5%, closing at ₹2,103 on the Bombay Stock Exchange. Investors responded positively to the regulatory progress, reflecting confidence in the company’s US growth trajectory.
Drug Component | Strength (mg) | US Market Sales (USD million) |
Darunavir | 800 mg | $1,374M (combined) |
Cobicistat | 150 mg | Included in total |
Emtricitabine | 200 mg | Included in total |
Tenofovir Alafenamide | 10 mg | Included in total |
Lupin’s tentative USFDA approval for its generic HIV treatment marks a step forward in strengthening its US portfolio. While the company did not classify this approval as a material event under SEBI regulations, it remains a significant development for Lupin’s future market presence. With the Lupin share price rising post-announcement, investor sentiment suggests optimism for the company’s potential earnings growth.
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