Lupin Limited has informed the Exchange regarding a press release dated May 13, 2025, titled "Lupin Launches Tolvaptan Tablets in the U.S. with 180-Day Exclusivity ".
LUPIN · price
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Lupin has launched Tolvaptan Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg) in the United States after receiving approval from the U.S. FDA. The company holds first-to-file status, giving it 180 days of exclusive generic marketing rights before other generic competitors can enter. Tolvaptan is used to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) and is a generic version of Otsuka's Jynarque® brand. The reference brand had estimated U.S. annual sales of USD 1,467 million in FY 2024, representing a large addressable market. During the exclusivity period, Lupin will be the only generic supplier, which typically supports strong pricing and market share gains.
Positive for shareholders — the 180-day exclusivity allows Lupin to be the sole generic seller in a USD 1.47 billion U.S. market, potentially boosting near-term U.S. revenue and margins. This strengthens Lupin's complex generics pipeline and U.S. franchise, which could support the stock price in the short term.