Mumbai: Global pharma major Lupin Limited has announced the
launch of Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States, following the recent approval received from the United States Food and Drug Administration (U.S. FDA).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 U.S. to provide ADPKD patients
with increased access to high-quality treatment options,” said Vinita Gupta, CEO, Lupin.
Tolvaptan Tablets (RLD Jynarque) had an estimated annual sale of USD 1,467 million in the U.S. (fiscal
year ended December 31, 2024).Read also: Lupin gets green light from USFDA for kidney drug TolvaptanLupin 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. The company has a strong position in India and the U.S. across
multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal,
central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research
centers globally.Read also: Lupin wins USFDA okay for HIV-1 drug Raltegravir