Lupin Secures FDA Approval for Brivaracetam Oral Solution

Global pharmaceutical leader Lupin Limited has announced that it has received U.S. FDA approval for its Brivaracetam Oral Solution 10 mg/mL under the Abbreviated New Drug Application (ANDA) pathway.

This product is the bioequivalent of Briviact Oral Solution, 10 mg/mL, developed by UCB, Inc., and is prescribed for the treatment of partial-onset seizures in patients aged 1 month and older.

The approval marks an important milestone for Lupin, expanding its portfolio of epilepsy treatments and reinforcing its strong presence in the U.S. market.

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Brivaracetam Oral Solution is expected to provide a reliable, affordable alternative to the brand-name product, offering patients and healthcare providers an option with the same therapeutic benefits. The solution comes in an easy-to-administer oral form, improving patient compliance, especially for younger children or those with difficulty swallowing pills.

Following the regulatory approval, Lupin has already initiated the launch of its Brivaracetam Oral Solution in the United States. The product has an estimated annual sales potential of USD 135 million in the U.S., based on IQVIA’s MAT December 2025 data. Lupin's move to offer this bioequivalent is set to make a significant impact in the market, especially as demand for affordable seizure management options rises.

Lupin’s latest FDA approval highlights its ongoing commitment to enhancing access to high-quality, life-saving treatments. As the company moves forward with its launch, it is poised to provide patients with an important option for managing partial-onset seizures effectively and affordably.