New Launch24 Feb 2026, 07:21 pm
Lupin Ltd Announces Approval and Launch of Brivaracetam Oral Solution in the US with $135 Million Market
AI Summary
Global pharma major Lupin Limited has announced the approval and launch of Brivaracetam Oral Solution in the United States by the U.S. FDA. The bioequivalent to Briviact® Oral Solution, 10 mg/mL, of UCB, Inc., is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Lupin, a trusted healthcare professional and consumer brand worldwide, specializes in pharmaceutical products across multiple therapy areas and has a strong presence in India and the U.S. Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of USD 135 million in the U.S. (IQVIA MAT December 2025).
Key Highlights
- Lupin Ltd receives U.S. FDA approval for Brivaracetam Oral Solution ANDA
- Brivaracetam Oral Solution is bioequivalent to Briviact® Oral Solution, 10 mg/mL, of UCB, Inc.
- Indicated for the treatment of partial-onset seizures in patients 1 month of age and older
- Lupin Ltd initiates launch of Brivaracetam Oral Solution in the United States
- Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of USD 135 million in the U.S. (IQVIA MAT December 2025)