MUMBAI, India and NAPLES, Fla., Feb. 24, 2026 /PRNewswire/ — Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the U.S. FDA 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 USD 135 million in the U.S. (IQVIA MAT December 2025).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
Briviact® is a registered trademark of UCB, Inc.
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SOURCE Lupin Pharmaceuticals
