Global pharma major Lupin Ltd. has announced that it 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 US FDA. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.

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., and indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Eslicarbazepine Acetate Tablets had estimated annual sales of USD 395 million in the US (IQVIA MAT March 2025).

Lupin is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company enjoys a strong position in India and the US 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 centres globally.