Lupin Launches Eslicarbazepine Acetate Tablets in the United States, Eligible for 180 Days of Shared Generic Exclusivity

Global pharma major Lupin Limited has launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, in the United States following the approval of its Abbreviated New Drug Application (ANDA) from the U.S. FDA. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. Eslicarbazepine Acetate Tablets are bioequivalent to Aptiom® Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc., and indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine Acetate Tablets (RLD Aptiom®) had estimated annual sales of USD 395 million in the U.S. (IQVIA MAT March 2025).