Latest news with #Tolvaptan
Time of India
13-05-2025
- Business
- Time of India
Lupin launches generic version of kidney disorder treatment drug in US
Pharma major Lupin Ltd on Tuesday said it has launched the generic version of Tolvaptan tablets used to slow kidney function decline in the US market , following the recent approval received from the country's health regulator. The company has launched Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the US, after receiving the approval from the US Food and Drug Administration ( USFDA ). #Operation Sindoor The damage done at Pak bases as India strikes to avenge Pahalgam Why Pakistan pleaded to end hostilities Kashmir's Pahalgam sparks Karachi's nightmare "Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity," Lupin said in a statement. Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added. Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like She is Revealing Her Secret Strategy in Commodity Trading TradeWise Learn More Undo by Taboola by Taboola Lupin CEO Vinita Gupta said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
Business Upturn
13-05-2025
- Business
- Business Upturn
Lupin launches Tolvaptan tablets in the US for ADPKD treatment
By Aman Shukla Published on May 13, 2025, 12:00 IST Lupin Limited, a global pharmaceutical company, has announced the launch of its generic Tolvaptan Tablets in the United States following approval from the U.S. Food and Drug Administration (FDA). The product is available in multiple strengths: 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan Tablets are the generic equivalent of Jynarque®, a brand-name medication developed by Otsuka Pharmaceutical Company, Ltd. The drug is used to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Lupin has secured exclusive first-to-file status for the generic version of Tolvaptan, which grants the company 180 days of marketing exclusivity in the U.S. market. This exclusivity period allows Lupin to be the only generic manufacturer selling the product during that time. Vinita Gupta, CEO, Lupin, stated, '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.' According to available data, Jynarque® recorded estimated U.S. sales of approximately $1.467 billion for the fiscal year ending December 31, 2024. The launch of Tolvaptan Tablets is part of Lupin's strategy to expand its portfolio of affordable treatments in the U.S. pharmaceutical market. 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
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.
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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 rallies after receiving USFDA nod for Tolvaptan tablets
Lupin rose 1.09% to Rs 2,111.55 after the global pharmaceutical major received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tolvaptan Tablets. The drug is bioequivalent to Jynarque Tablets by Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic market exclusivity in the U.S. market. The product will be manufactured at Lupins Nagpur facility in India and is expected to launch soon. Tolvaptan is used to treat hyponatremia (low sodium levels in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). It is also approved to slow the progression of kidney function decline in adults at risk of rapidly advancing autosomal dominant polycystic kidney disease (ADPKD). The approved product has estimated annual sales of USD 1,467 million in the U.S. for the fiscal year ended 31 December 2024. Vinita Gupta, CEO of Lupin, said,We are very pleased to have obtained approval for generic Tolvaptan from the U.S. FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally. Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupins consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.
