Lupin receives U.S. FDA approval for Tolvaptan tablets with 180-day exclusivity

Business Upturn

24-04-2025

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: www.lupin.com 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.
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