Latest news with #Jynarque
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.
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Business Standard
24-04-2025
- Business
- Business Standard
Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan
Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator for its generic version of Tolvaptan tablets indicated for a certain type of kidney disease. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, Lupin said in a regulatory filing. These are bioequivalent to Jynarque tablets in the same strengths of Otsuka Pharmaceutical Company Ltd, it added. "Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin's Nagpur facility and will be launched soon," the company said. Commenting on the approval, Lupin CEO Vinita Gupta said,"This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally." Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it said. These tablets had an estimated annual sale of $1,467 million in the US in 2024.
Business Standard
24-04-2025
- Business
- Business Standard
Lupin receives USFDA approval for Tolvaptan Tablets
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan Tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin's Nagpur facility in India and will be launched soon. Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
