
New Launch13 May 2025, 11:57 am
Lupin Launches Tolvaptan Tablets in the U.S. with 180-Day Exclusivity
AI Summary
Global pharma major Lupin Limited has announced the launch of Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States. The company holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity. Tolvaptan Tablets are bioequivalent to Jynarque® Tablets and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The product had an estimated annual sale of USD 1,467 million in the U.S. (fiscal year ended December 31, 2024).
Key Highlights
- Lupin has launched Tolvaptan Tablets in the U.S. with 180-day exclusivity.
- The product is indicated to slow kidney function decline in adults at risk of rapidly progressing ADPKD.
- Lupin holds the exclusive first-to-file status for this product.
- Tolvaptan Tablets are bioequivalent to Jynarque® Tablets of Otsuka Pharmaceutical Company, Ltd.
- The product had an estimated annual sale of USD 1,467 million in the U.S. (fiscal year ended December 31, 2024).