Lupin gains U.S. FDA approval for Tolvaptan tablets

Lupin Limited announced it has received U.S. FDA approval for its Abbreviated New Drug Application for Tolvaptan Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg). The tablets are bioequivalent to Jynarque® Tablets, used to treat autosomal dominant polycystic kidney disease (ADPKD). Lupin's product benefits from being the exclusive first-to-file generic, granting it 180 days of market exclusivity. Tolvaptan Tablets will be manufactured at Lupin's facility in Nagpur, India, and launched shortly. Jynarque® had an estimated annual sale of USD 1,467 million in the U.S. as of December 31, 2024.