New Delhi, May 7 (PTI) Pharma major Lupin Ltd on Wednesday said it has launched in the US its generic version of Eslicarbazepine Acetate tablets used in the treatment of partial-onset seizures.
The company has launched the drug in strengths of 200 mg, 400 mg, 600 mg, and 800 mg, following the approval of its abbreviated new drug application (ANDA) from the USFDA, Lupin said in a regulatory filing.
The company is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity, it added.
Eslicarbazepine Acetate tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Aptiom tablets in the same strengths of Sumitomo Pharma America, Inc.
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older, Lupin said.
Citing IQVIA MAT March 2025 data, Lupin said Eslicarbazepine Acetate tablets, Aptiom had estimated annual sales of USD 395 million in the US.
Lupin launches generic drug in US
PTI
Updated: May 07, 2025 18:30 IST
(This story has not been edited by THE WEEK and is auto-generated from PTI)
