Lupin Secures USFDA Approval for Tolvaptan Tablets

24 Apr 2025 , 09:39 PM

Lupin Ltd. has received approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Tolvaptan tablets. The approval includes multiple strengths: 15mg, 30mg, 45mg, 60mg, and 90mg, allowing for flexible dosing options.

Lupin is the first company to file for the generic version of Tolvaptan in the U.S., making it eligible for 180 days of market exclusivity under the Hatch-Waxman Act. The drug will be manufactured at Lupin’s facility in Nagpur, India, and the company has announced plans for a near-term launch in the U.S. market.

Tolvaptan tablets by Lupin are the bioequivalent of Jynarque tablets, developed by Otsuka Pharmaceutical Company. The drug is indicated for slowing kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

As of December 31, 2024, the reference drug Tolvaptan recorded annual sales of approximately $1.47 billion in the U.S., highlighting the product’s strong market potential.

The approval and upcoming launch mark a significant step for Lupin in expanding its specialty and complex generics portfolio in regulated markets like the United States. This development strengthens Lupin’s position in the nephrology segment, supporting its growth strategy in high-value therapeutic areas.