Lupin Limited has announced regulatory approval from the United States Food and Drug Administration (US FDA) for its Brivaracetam Oral Solution, marking a further expansion of the company’s presence in the US pharmaceutical market.
The approval allows the company to commercialise the treatment for seizure management, strengthening its portfolio in neurological therapies while supporting its broader global growth strategy.
The company received approval for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL. Following regulatory clearance, Lupin has commenced the product’s launch in the United States.
The medication is a bioequivalent version of the reference listed drug and is prescribed for the treatment of partial-onset seizures in patients aged one month and above. The approval enables Lupin to participate in a therapy segment addressing neurological disorders within the US generics market.
According to industry estimates, the reference product recorded annual sales of approximately USD 135 million in the United States for the period ending December 2025. Entry into this market provides Lupin with an opportunity to expand its offerings within the central nervous system therapeutic category while strengthening its presence in regulated markets.
Lupin continues to focus on complex generics, branded formulations, biotechnology products, and active pharmaceutical ingredients across multiple therapy areas. The addition of Brivaracetam Oral Solution aligns with the company’s strategy of expanding products that address specialised treatment needs, particularly in neurological and chronic disease segments.
Headquartered in Mumbai, Lupin operates across more than 100 markets worldwide. The company maintains manufacturing facilities and research centres across various regions and supports healthcare systems through a diversified portfolio covering respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, and women’s health therapies.
Its broader operations also include subsidiaries focused on diagnostics, digital health solutions, and manufacturing services aimed at supporting long-term healthcare delivery.
Shares of Lupin Limited traded higher during intraday activity on February 25, 2026. The stock was quoted at ₹2,289.90, reflecting a gain of ₹39.70 or 1.76% compared with the previous close of ₹2,250.20.
The stock opened at ₹2,267.20 and moved within a day’s range of ₹2,254.80 to ₹2,299.70, indicating steady trading activity during the session amid ongoing corporate developments.
Read More:Natco Pharma Share Price Jumps 11% in 4 Sessions on Semaglutide Approval.
The approval and launch of Brivaracetam Oral Solution represent another regulatory milestone for Lupin in the US market. The development adds to the company’s neurological treatment portfolio while supporting its strategy of expanding in regulated pharmaceutical markets. Future performance will depend on market adoption, competitive dynamics, and continued progress in product development and regulatory approvals.
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Published on: Feb 25, 2026, 2:43 PM IST
Neha Dubey
Neha Dubey is a Content Analyst with 3 years of experience in financial journalism, having written for a leading newswire agency and multiple newspapers. At Angel One, she creates daily content on finance and the economy. Neha holds a degree in Economics and a Master’s in Journalism.
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