First-to-File, First to Win: Lupin’s Tolvaptan Triumph Targets $1.47 Billion U.S. Market

Global pharma major Lupin Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its generic Tolvaptan Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg), marking a strategic milestone in its U.S. expansion. As the exclusive first-to-file generic manufacturer, Lupin will enjoy 180 days of marketing exclusivity, giving it a significant edge in the high-value nephrology market.

 

Key Highlights:

With this approval, Lupin is poised to capture a substantial share of the U.S. nephrology market while advancing its global growth strategy.

 

Source: NSE India, Business Upturn, Lupin, India Infoline