Latest news with #EslicarbazepineAcetateTablets
Business Standard
08-05-2025
- Business
- Business Standard
Lupin gets USFDA nod for Eslicarbazepine Acetate tablets
Lupin announced that it has received an approval from US Food and Administration (USFDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg. 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 companys 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.
Business Upturn
07-05-2025
- Business
- Business Upturn
Lupin launches Eslicarbazepine Acetate Tablets in the US
By Aman Shukla Published on May 7, 2025, 16:29 IST Lupin Limited has announced the launch of Eslicarbazepine Acetate Tablets in the U.S. market. The product is available in 200 mg, 400 mg, 600 mg, and 800 mg strengths. The launch follows the U.S. Food and Drug Administration (FDA) approval of Lupin's Abbreviated New Drug Application (ANDA). As one of the first ANDA applicants, Lupin is eligible for 180 days of shared generic exclusivity. Eslicarbazepine Acetate Tablets are the generic version of Aptiom® by Sumitomo Pharma America, Inc. The medication is used for treating partial-onset seizures in patients aged 4 years and older. Lupin's version is deemed bioequivalent to the brand-name drug, ensuring similar safety and effectiveness. According to IQVIA MAT data as of March 2025, Aptiom® had estimated annual U.S. sales of around USD 395 million, indicating strong market potential for Lupin's launch. This development strengthens Lupin's U.S. generics portfolio and reinforces its commitment to delivering high-quality, affordable medications to patients. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
