Lupin Secures USFDA Nod for Epilepsy Drug Brivaracetam in US
Mumbai: Mumbai-based pharmaceutical major Lupin Limited has received approval from the US Food and Drug Administration (USFDA) for its Brivaracetam Oral Solution 10 mg/mL and has launched the product in the United States for the treatment of partial-onset seizures in patients aged one month and older.
The approval was granted for Lupin’s Abbreviated New Drug Application (ANDA) for the oral solution, which is bioequivalent to Briviact Oral Solution, 10 mg/mL, originally developed by UCB, Inc. Brivaracetam belongs to the anti-epileptic drug class and is used in the management of seizures associated with epilepsy.
Following the regulatory approval, the company has initiated the commercial launch of the product in the US market, marking an expansion of its central nervous system portfolio. The reference listed drug (RLD), Briviact Oral Solution, recorded estimated annual sales of approximately USD 135 million in the United States, according to IQVIA data for the 12-month period ending December 2025.
Lupin Limited, headquartered in Mumbai, is a global pharmaceutical company with a presence in over 100 markets. The company develops and manufactures branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. It has established strong capabilities across multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
The company operates 15 manufacturing facilities and seven research centers worldwide and employs more than 24,000 professionals. Through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, the company continues to focus on expanding its global pharmaceutical footprint.
