Lupin announced on February 24, 2026, that it received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution (10 mg/mL). The company immediately initiated the launch in the United States. This product is bioequivalent to UCB, Inc.’s Briviact® Oral Solution and treats partial-onset seizures in patients aged 1 month and older. The original product had estimated annual sales of USD 135 million in the U.S.
U.S. FDA Approval Secured for Brivaracetam Solution
Global pharmaceutical major Lupin Limited announced today, February 24, 2026, that it has successfully received approval from the U.S. Food and Drug Administration (FDA). The approval covers the Abbreviated New Drug Application (ANDA) for its Brivaracetam Oral Solution, 10 mg/mL.
Following this key regulatory milestone, Lupin has immediately commenced the launch of the product in the United States. Brivaracetam Oral Solution is indicated for the treatment of partial-onset seizures in pediatric and adult patients, specifically those 1 month of age and older.
Market Opportunity and Product Context
The approved generic product is bioequivalent to the branded reference listed drug (RLD), Briviact® Oral Solution (10 mg/mL), manufactured by UCB, Inc. The market potential is significant, as the RLD generated estimated annual sales reaching USD 135 million in the U.S. market as of December 2025 (based on IQVIA data).
About Lupin’s Global Footprint
Lupin Limited is headquartered in Mumbai, India, and operates as a global pharmaceutical leader, distributing products across more than 100 markets worldwide. The company specializes in a diverse portfolio, encompassing branded generics, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs). Lupin maintains a robust operational scale, featuring 15 state-of-the-art manufacturing sites and 7 dedicated research centers globally, supported by a workforce exceeding 24,000 professionals.
Source: BSE
