Lupin Limited, a global pharmaceutical company, has announced the launch of its generic Tolvaptan Tablets in the United States following approval from the U.S. Food and Drug Administration (FDA). The product is available in multiple strengths: 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
Tolvaptan Tablets are the generic equivalent of Jynarque®, a brand-name medication developed by Otsuka Pharmaceutical Company, Ltd. The drug is used to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Lupin has secured exclusive first-to-file status for the generic version of Tolvaptan, which grants the company 180 days of marketing exclusivity in the U.S. market. This exclusivity period allows Lupin to be the only generic manufacturer selling the product during that time.
Vinita Gupta, CEO, Lupin, stated, “We are pleased to announce the launch of Tolvaptan Tablets in the U.S. to provide ADPKD patients with increased access to high-quality treatment options.”
According to available data, Jynarque® recorded estimated U.S. sales of approximately $1.467 billion for the fiscal year ending December 31, 2024.
The launch of Tolvaptan Tablets is part of Lupin’s strategy to expand its portfolio of affordable treatments in the U.S. pharmaceutical market.
