
Drug maker Lupin Limited announced that the FDA has approved an Abbreviated New Drug Application for its generic tolvaptan 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets. As the exclusive first-to-file for this drug, the company is eligible for 180 days of generic drug exclusivity.
The FDA approved tolvaptan in April 2018 to slow kidney function decline in adults at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is the first approved treatment for ADPKD, which is the fourth leading cause of end-stage renal disease. The drug is currently marketed by Otsuka under the brand name Jynarque.
Lupin CEO Vinita Gupta said in a statement, “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.”
The generic tolvaptan tablets will be manufactured in Nagpur, India, and are expected to launch soon.
Sources:
Lupin. Accessed April 25, 2025. https://www.lupin.com/lupin-receives-approval-from-u-s-fda-for-tolvaptan-tablets/
Otsuka. Accessed April 25, 2025. https://www.otsuka-us.com/discover/articles-1188