Lupin Limited — Updates, 24-04-2025: Press Release

Lupin has received approval from the U.S. FDA for its Abbreviated New Drug Application for Tolvaptan Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg), which are bioequivalent to Jynarque® Tablets by Otsuka Pharmaceutical Company. As the exclusive first-to-file for this product, Lupin will enjoy 180 days of generic drug exclusivity. The tablets, intended to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), will be manufactured at Lupin’s Nagpur facility with plans for a quick launch. Given Jynarque's estimated annual sales of USD 1,467 million in the U.S. for the fiscal year ending December 2024, this approval represents a significant growth opportunity in the nephrology market for Lupin, marking a positive outlook as the company expands its therapeutic portfolio.