Lupin Limited, a leading global pharmaceutical company, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tolvaptan Tablets in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.

These tablets are the generic equivalent of Jynarque® Tablets by Otsuka Pharmaceutical Company, Ltd. Lupin is the exclusive first-to-file applicant for this product, securing 180 days of marketing exclusivity in the U.S. The product will be manufactured at Lupin’s Nagpur facility in India and is expected to be launched soon.

Tolvaptan is prescribed to slow the progression of kidney function decline in adults at risk of rapidly advancing autosomal dominant polycystic kidney disease (ADPKD).

“We are thrilled to receive FDA approval for our generic version of Tolvaptan,” said Vinita Gupta, CEO of Lupin. “This approval represents a strategic move into the nephrology segment and reflects our dedication to addressing critical unmet medical needs worldwide.”

Tolvaptan Tablets (reference listed drug Jynarque®) recorded estimated annual U.S. sales of approximately USD 1.47 billion for the fiscal year ending December 31, 2024.