U.S. FDA grants approval for Lupin’s generic Tolvaptan tablets  

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Tolvaptan tablets of different strengths.

It is the exclusive first-to-file for this product and consequently eligible for 180 days of generic drug exclusivity. The product will be manufactured at its Nagpur facility and launched soon, Lupin said on Thursday.

The approved product is bioequivalent to Otsuka Pharmaceutical Company’s Jynarque 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.

Tolvaptan tablets had an estimated annual sale of $1,467 million in the U.S. during 2024.

CEO Vinita Gupta said the development marks “a significant entry into the nephrology segment” for the company.