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Business Standard
13-05-2025
- Business
- Business Standard
Lupin rises after launching Talvaptan tablets in US market
Lupin gained 2.81% to Rs 2,098.35 after the company announced the launch of Tolvaptan Tablets in the U.S. market, with 180-day exclusivity under the first-to-file status. The tablets are the generic version of Jynarque, developed by Otsuka Pharmaceutical Company, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The product has an estimated annual market size of $1,467 million in the U.S. for the fiscal year ended 31 December 2024. Vinita Gupta, CEO of Lupin, said, We are pleased to announce the launch of Tolvaptan Tablets in the U.S. to provide ADPKD patients with increased access to high-quality treatment options. 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 Hindu
24-04-2025
- Business
- The Hindu
U.S. FDA grants approval for Lupin's generic Tolvaptan tablets
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Tolvaptan tablets of different strengths. It is the exclusive first-to-file for this product and consequently eligible for 180 days of generic drug exclusivity. The product will be manufactured at its Nagpur facility and launched soon, Lupin said on Thursday. The approved product is bioequivalent to Otsuka Pharmaceutical Company's Jynarque Tablets 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. Tolvaptan tablets had an estimated annual sale of $1,467 million in the U.S. during 2024. CEO Vinita Gupta said the development marks 'a significant entry into the nephrology segment' for the company.
