Pharma major Lupin has received U.S. FDA approval for its Brivaracetam Oral Solution (10 mg/ml), a generic equivalent of UCB’s Briviact®, used in treating partial-onset seizures in epilepsy patients aged one month and older. The approval enhances Lupin’s neurology offerings and expands its footprint in the U.S. generics market.
On February 23, 2026, Lupin announced that the U.S. Food and Drug Administration (FDA) has approved its Abuse-Deterrent Brivaracetam Oral Solution (10 mg/ml). This formulation is indicated for the treatment of partial-onset seizures in patients one month of age and older, offering a cost-effective alternative to UCB’s branded drug Briviact®.
The approval is a significant milestone for Lupin, which has been focusing on strengthening its neurology and central nervous system (CNS) portfolio. Brivaracetam is a widely prescribed antiepileptic drug, and Lupin’s entry into this segment is expected to improve accessibility for patients while boosting the company’s U.S. generics business.
Major Takeaways
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Lupin receives FDA approval for Brivaracetam Oral Solution (10 mg/ml)
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Generic equivalent of UCB’s Briviact®, used for partial-onset seizures
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Approved for patients aged one month and older
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Strengthens Lupin’s neurology and CNS portfolio in the U.S.
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Expands Lupin’s generics footprint in the American pharmaceutical market
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Enhances patient access to affordable epilepsy treatment options
Conclusion
The FDA approval of Brivaracetam Oral Solution marks a strategic win for Lupin, reinforcing its commitment to neurology innovation and affordable healthcare. With this launch, Lupin is poised to capture a larger share of the U.S. epilepsy treatment market while supporting patients with accessible therapies.
Sources: Business Standard, The Economic Times, U.S. FDA Press Release