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SAURABH SAHU

24th Feb · SEBI-Registered Analyst

Lupin Gets USFDA Approval, Launches Brivaracetam Oral Solution in the U.S.! 🚀

India’s pharma major **Lupin Limited** has announced a fresh regulatory win! 🎉 The company has received approval from the **U.S. Food and Drug Administration** (USFDA) for its **Brivaracetam Oral Solution (10 mg/mL)** and has officially launched the product in the United States. 🇺🇸 The approved product is a bioequivalent version of **Briviact**, originally marketed by **UCB, Inc.**. It is used for the treatment of partial-onset seizures in patients aged one month and above — a crucial therapy area in the Central Nervous System (CNS) segment 🧠💊. 📊 As per IQVIA MAT (December 2025), the reference drug recorded estimated annual U.S. sales of **USD 135 million**, indicating a solid revenue opportunity for Lupin in the American generics market. 🔎 Why This Matters: * ✅ Expands Lupin’s U.S. generics portfolio * ✅ Strengthens presence in the CNS therapy segment * ✅ Adds a meaningful product to its complex generics pipeline * ✅ Supports revenue visibility in a regulated market With operations in over 100 countries 🌍 and a strong foothold in India and the U.S., Lupin continues to build momentum through strategic approvals and timely launches. 📈 Investors will closely watch how this launch contributes to U.S. sales growth in the coming quarters. --- ⚠️ **Disclaimer:** This post is for informational purposes only and not investment advice. Please consult your financial advisor before making any investment decisions.

LUPIN

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