Following the recent approval received from the United States Food and Drug Administration (FDA), global pharma major Lupin Limited (Lupin) announced the launch of tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States. Lupin 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, Ltd., and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
""We are pleased to announce the launch of tolvaptan tablets in the US to provide ADPKD patients with increased access to high-quality treatment options,” said Vinita Gupta, CEO, Lupin.
Tolvaptan tablets (Jynarque) had an estimated annual sale of USD 1,467 million in the US (fiscal year ended December 31, 2024).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.