Shares of Lupin Ltd were trading in the green and 1% higher on 8 May after the company announced securing USFDA approval. 

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) has approved eslicarbazepine acetate tablets with strengths of 200 mg, 400 mg, 600 mg, and 800 mg.

The company was one of the initial ANDA applications, and therefore is entitled for 180 days of shared generic exclusivity.

Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Sumitomo Pharma America, Inc.’s Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, and are recommended for the treatment of partial-onset seizures in patients aged 4 years and older.

According to IQVIA MAT March 2025, Eslicarbazepine Acetate Tablets had a $395 million yearly sales in the United States.

Lupin is a multinational pharmaceutical company headquartered in Mumbai, India, with products available in over 100 locations. It focuses on pharmaceutical items, such as branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company’s consolidated net profit increased 39.5% to Rs 855.16 crore in Q3 FY25, from Rs 613.12 crore in Q4 FY24. Net sales increased by 10.6% year on year to Rs 5618.56 crore in the quarter ending 31 March 2025.

However, at 12:47 pm, the shares of Lupin shed all their early gains and were trading 1.32% lower at Rs 2,044.10 on NSE.

Wondering About Lupin Ltd? The Analyst Has Answers.

Ready to invest like a pro? Unicorn Signals app equips you with 100+ Free tools and knowledge you need to succeed. Download the Unicorn Signals app and gain access to daily stock lists and insightful market analysis and much more!