Lupin gets USFDA nod for Eslicarbazepine Acetate tablets

The company 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.

As per IQVIA MAT March 2025, Eslicarbazepine Acetate Tablets had estimated annual sales of $395 million in the U.S.

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

The company's consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025.

The scrip advanced 1.08% to end at Rs 2,070.95 on Wednesday, 7 May 2025.

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