Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator for its generic version of Tolvaptan tablets indicated for a certain type of kidney disease.

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, Lupin said in a regulatory filing.

These are bioequivalent to Jynarque tablets in the same strengths of Otsuka Pharmaceutical Company Ltd, it added.

"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 and will be launched soon," the company said.

Commenting on the approval, Lupin CEO Vinita Gupta said,"This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally."  Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it said.

These tablets had an estimated annual sale of $1,467 million in the US in 2024.