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Lupin launches Tolvaptan Tablets in United States
May-13-2025

Following the recent approval received from the United States Food and Drug Administration (USFDA), Lupin has launched Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States (US). 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, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan Tablets (RLD Jynarque) had an estimated annual sale of $1,467 million in the US (fiscal year ended December 31, 2024).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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