Lupin gets USFDA approval for kidney drug Tolvaptan; share price up 2.3%

Following this, shares of Lupin were trading 2.35% higher at ₹2,138.50 apiece on the National Stock Exchange.  

“Tolvaptan Tablets are bioequivalent to Jynarque® Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd,” Lupin said in a statement to stock exchanges.

Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity, the firm said.

The product will be manufactured at Lupin’s Nagpur facility and will be launched soon.

“We are very pleased to have obtained approval for generic tolvaptan from the U.S. FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally,” said Vinita Gupta, CEO, Lupin.

Tolvaptan Tablets (RLD Jynarque®) had an estimated annual sale of $1,467 million in the US (fiscal year ended December 31, 2024).

Based in Mumbai, Lupin is a global pharmaceutical leader with products distributed in over 100 markets. Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

On Wednesday, shares of Lupin opened at ₹2,089.60 apiece and touched an intraday high of ₹2,149.50.

The stock has gained over 8% over the last five trading sessions. It has declined 10.79% since the beginning of the year.

The pharmaceutical scrip had touched its 52-week high of ₹2,402.90 apiece on January 2, 2025, and its one-year low of ₹1,493.30 per share on June 4, 2024.

Lupin Ltd has a total market capitalisation of ₹96,837.45 crore as of April 24, 2025, on the NSE and had a trading volume of 7.61 lakh on the same day.