Lupin unveils partial onset seizures drug Eslicarbazepine Acetate in US
Mumbai: Global pharma major Lupin Limited has announced that the company has
launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, following the
approval of its Abbreviated New Drug Application (ANDA) from the U.S. FDA.
The product is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc..
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According to the Company, it is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
Eslicarbazepine Acetate Tablets (RLD Aptiom) had estimated annual sales of USD 395 million in the
U.S. (IQVIA MAT March 2025).
Last year, Lupin secured the USFDA approval for its Abbreviated New Drug Application for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent of Trokendi XR Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, of Supernus Pharmaceuticals, Inc.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in
over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations,
complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across
multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal,
central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research
centers globally.