Lupin gets USFDA’s nod for Brivaracetam Oral Solution
Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States
Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL. Brivaracetam is the bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States.
Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of $135 million in the U.S. (IQVIA MAT December 2025).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
