Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for brivaracetam oral solution 10 mg/mL.

The approved product is bioequivalent to the reference listed drug (RLD), Briviact oral solution, 10 mg/mL, marketed by UCB. It is indicated for the treatment of partial-onset seizures in patients aged one month and older.

Following regulatory clearance, Lupin has initiated the launch of brivaracetam oral solution in the United States.

According to IQVIA MAT data for December 2025, Briviact oral solution recorded estimated annual sales of approximately USD 135 million in the US, presenting a significant market opportunity for the generic version.

Mumbai-headquartered Lupin Limited is a global pharmaceutical company with a presence in over 100 markets worldwide. The company’s portfolio spans branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.