Lupin gets USFDA nod for Brivaracetam Oral Solution

Lupin said it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL.

Brivaracetam Oral Solution is bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients aged one month and older.

Following the regulatory approval, the company has initiated the launch of Brivaracetam Oral Solution in the United States market.

According to IQVIA MAT data for December 2025, Brivaracetam Oral Solution (RLD Briviact) recorded estimated annual sales of $135 million in the US.

The approval strengthens Lupins portfolio in the central nervous system (CNS) segment and reinforces its presence in the US generics market.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

The counter rose 0.48% to Rs 2,263.85 on the BSE.

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