Global pharma major Lupin Limited on Thursday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg.
The approval has been granted to market a generic equivalent of Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc.
Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.
Eslicarbazepine Acetate Tablets are 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 354 million in the U.S. (IQVIA MAT January 2024).
