07-05-2025
Lupin launches Eslicarbazepine Acetate Tablets in the US
By Aman Shukla Published on May 7, 2025, 16:29 IST
Lupin Limited has announced the launch of Eslicarbazepine Acetate Tablets in the U.S. market. The product is available in 200 mg, 400 mg, 600 mg, and 800 mg strengths.
The launch follows the U.S. Food and Drug Administration (FDA) approval of Lupin's Abbreviated New Drug Application (ANDA). As one of the first ANDA applicants, Lupin is eligible for 180 days of shared generic exclusivity.
Eslicarbazepine Acetate Tablets are the generic version of Aptiom® by Sumitomo Pharma America, Inc. The medication is used for treating partial-onset seizures in patients aged 4 years and older. Lupin's version is deemed bioequivalent to the brand-name drug, ensuring similar safety and effectiveness.
According to IQVIA MAT data as of March 2025, Aptiom® had estimated annual U.S. sales of around USD 395 million, indicating strong market potential for Lupin's launch.
This development strengthens Lupin's U.S. generics portfolio and reinforces its commitment to delivering high-quality, affordable medications to patients.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
