Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity

Mumbai, Naples, April 24, 2025: Global pharma major Lupin Limited (Lupin) today announced that it 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, Ltd. 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).

“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,” 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

Jynarque^® is the registered trademark of Otsuka Pharmaceutical Company Ltd