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Indian pharmaceutical major Lupin has received USFDA approval for its Eslicarbazepine Acetate Tablets in strengths of 200 mg, 400 mg, 600 mg, and 800 mg. The tablets are bioequivalent to Aptiom, a drug developed by Sumitomo Pharma America, Inc., and are used in the treatment of partial-onset seizures in patients aged 4 years and above.
Lupin is among the first Abbreviated New Drug Application (ANDA) filers for this product, making it eligible for 180 days of shared generic exclusivity in the U.S. market.
According to IQVIA MAT March 2025 data, the annual U.S. sales of Eslicarbazepine Acetate Tablets are estimated at $395 million, offering significant revenue potential.
The approval comes on the heels of Lupin's strong financial performance. The company posted a 39.5% jump in consolidated net profit to Rs 855.16 crore in Q3 FY25, with net sales rising 10.6% YoY to Rs 5,618.56 crore.
Lupin’s stock reacted positively to the news, gaining 1.08% to close at Rs 2,070.95 on May 7, 2025.
Disclaimer
This news article is for informational purposes only and does not constitute financial or medical advice. Jobaaj News encourages readers to consult certified professionals before making investment or healthcare decisions.
