Lupin Launches Tolvaptan Tablets in the U.S. with 180-Day Exclusivity
Mumbai, Naples, May 13, 2025: Following the recent approval received from the United States Food and Drug Administration (U.S. FDA), global pharma major Lupin Limited (Lupin) today announced the launch of Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States. Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity.
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).
"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,” said Vinita Gupta, CEO, Lupin.
Tolvaptan Tablets (RLD Jynarque®) had an estimated annual sale of USD 1,467 million in the U.S. (fiscal year ended December 31, 2024).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries please contact –
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
*Safe Harbor Statement
Jynarque® is the registered trademark of Otsuka Pharmaceutical Company Ltd.
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