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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
Business Upturn
24-04-2025
- Business
- Business Upturn
Lupin receives U.S. FDA approval for Tolvaptan tablets with 180-day exclusivity
Lupin Limited shares are in focus today following the announcement that the company has received U.S. FDA approval for its generic version of Tolvaptan Tablets, used for treating autosomal dominant polycystic kidney disease (ADPKD). This approval positions Lupin as the exclusive first-to-file generic manufacturer, granting the company 180 days of marketing exclusivity in the United States. Tolvaptan targets high-value U.S. nephrology market Lupin's Tolvaptan Tablets – in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg – are bioequivalent to Jynarque®, a brand marketed by Otsuka Pharmaceutical Company Ltd. The drug is indicated to slow kidney function decline in adults at risk of rapidly progressing ADPKD. According to IQVIA data, Jynarque® generated estimated annual U.S. sales of $1.47 billion for the fiscal year ended December 2024, highlighting the significance of this launch for Lupin's U.S. business. The drug will be manufactured at Lupin's Nagpur facility in India, and the company confirmed that a market launch is imminent. Strategic remarks from Lupin leadership Vinita Gupta, CEO of Lupin, stated: '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.' Why this matters First-to-file status secures Lupin a 6-month window without generic competition in the U.S. Entry into the nephrology segment marks a new therapy area for expansion. Reinforces Lupin's U.S. presence, already a stronghold for the company's revenues. About Lupin Lupin Limited, headquartered in Mumbai, is a global pharma leader with a footprint in over 100 markets. The company operates 15 manufacturing sites and 7 research centers worldwide. It has a strong presence in multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, and CNS segments. Its subsidiaries also cover diagnostics, digital health, and complex generics. For more details, visit: FAQs What is Tolvaptan used for? It is prescribed to slow kidney function decline in adults with ADPKD. What is Lupin's advantage with this approval? Lupin is the first generic filer, granting it 180-day market exclusivity in the U.S. How big is the market opportunity? The reference drug Jynarque® saw U.S. sales of approximately $1.47 billion in 2024. When will Lupin launch the product? Lupin has confirmed the launch is planned soon, with manufacturing handled at its Nagpur plant. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
