Lupin Share Price Gains After U.S. FDA Nod for Generic Tolvaptan with 180-Day Market Exclusivity

On April 24, 2025, Lupin Limited, a leading global pharmaceutical company, received approval from the  U.S. FDA to launch its generic version of Tolvaptan Tablets in the U.S. The approved strengths include 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.

First-to-File Advantage

Lupin is the first company to file for approval of generic Tolvaptan and will enjoy 180 days of marketing exclusivity in the U.S. This means Lupin will be the only company allowed to sell the generic version for six months after launch.

Read More, HUL Q4 FY25 Results: Net Profit Drops 3.7% YoY, Declares ₹53 Total Dividend for FY25.  

About the Drug

Tolvaptan helps slow the decline in kidney function in adults with ADPKD (autosomal dominant polycystic kidney disease), a condition that causes the kidneys to enlarge and gradually lose their ability to function properly.

Manufacturing and Launch

The drug will be made at Lupin’s facility in Nagpur, India, and will be available in the U.S. market soon.

“We’re excited about this approval,” said Vinita Gupta, CEO of Lupin. “It strengthens our presence in the nephrology segment and shows our commitment to helping patients worldwide.”

Market Opportunity

The brand-name version of the drug, Jynarque® by Otsuka Pharmaceuticals, had estimated U.S. sales of $1.47 billion in the year ending December 31, 2024.

About Lupin

Headquartered in Mumbai, Lupin is a global leader in pharmaceuticals, operating in over 100 countries. The company offers branded and generic medicines, complex generics, biotech products, and active pharmaceutical ingredients. It has a strong presence in key therapy areas such as respiratory, heart disease, diabetes, infections, and women’s health. 

As of April 24, 2025, Lupin share price is trading at ₹2,124.10, up by ₹34.60 or 1.66% for the day. The stock opened at ₹2,089.60 and touched an intraday high of ₹2,149.50 and a low of ₹2,082.50. The company has a market capitalisation of ₹96,920 crore, a price-to-earnings (P/E) ratio of 33.85, and a dividend yield of 0.38%. Over the past year, the stock has touched a 52-week high of ₹2,402.90 and a 52-week low of ₹1,493.30.

Conclusion

Lupin’s FDA approval for generic Tolvaptan marks a major stride in its U.S. growth strategy and nephrology portfolio. With market exclusivity and strong manufacturing capabilities, the company is well-positioned to tap into a high-value therapeutic segment while expanding its global impact on patient health.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.                     

Investments in securities market are subject to market risks, read all the related documents carefully before investing.