Lupin gets green light from USFDA for kidney drug Tolvaptan
Mumbai: Global pharma major, Lupin Limited, 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 is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Tolvaptan Tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd.
As per the release, 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.
“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).
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. The company has 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.
