Lupin Limited has successfully resolved its patent infringement dispute with Astellas Pharma through a comprehensive settlement agreement worth USD 90 million. The pharmaceutical company disclosed this development to stock exchanges on February 10, 2026, pursuant to regulatory requirements under SEBI Listing Regulations.

Settlement Agreement Details

The Settlement and License Agreement involves Lupin Limited and its wholly owned subsidiary Lupin Pharmaceuticals, Inc., USA, along with Astellas Pharma, Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global Development, Inc. The dispute centered around Lupin's Mirabegron product, which had been subject to patent infringement claims.

Financial and Operational Impact

Under the agreement terms, Lupin will make the substantial USD 90 million payment, which includes the USD 75 million prepaid option payment as the primary component. Additionally, the company will pay a prepaid per unit license fee for each unit of Lupin's Mirabegron product sold from the settlement date through September 2027.

The settlement provides significant operational benefits for Lupin by allowing the company to continue selling its Mirabegron product without further legal complications. This resolution eliminates the uncertainty and potential costs associated with prolonged patent litigation.

Background and Resolution

This settlement concludes the patent infringement dispute that Lupin had previously disclosed to exchanges in April 2025. The litigation involved multiple Astellas entities and posed potential risks to Lupin's ability to market its Mirabegron product in relevant jurisdictions.

The confidential nature of the settlement terms suggests both parties found mutually acceptable conditions that balance Lupin's commercial interests with Astellas' patent rights. The agreement structure, incorporating both upfront payments and ongoing per-unit fees, provides a framework for continued product commercialization while respecting intellectual property considerations.

Strategic Implications

The resolution allows Lupin to maintain its market position for the Mirabegron product while providing certainty for future operations through September 2027. The settlement eliminates litigation risks and associated legal costs, enabling the company to focus on commercial execution and market development for this therapeutic product.

Lupin has announced the launch of Topiramate Extended-Release Capsules in the United States market, marking another significant milestone in the pharmaceutical company's U.S. operations. The launch targets a substantial market opportunity with considerable revenue potential.

Product Launch Details

The company has introduced Topiramate Extended-Release Capsules to the U.S. market, expanding its generic pharmaceutical portfolio in the region. This product launch represents Lupin's strategic focus on bringing affordable generic alternatives to American patients.

Market Opportunity

The launch targets an estimated annual sales opportunity of USD 164 million, indicating the significant market potential for this therapeutic product. This substantial market size reflects the demand for Topiramate Extended-Release Capsules in the U.S. healthcare system.

Strategic Significance

This product launch aligns with Lupin's ongoing strategy to strengthen its presence in the U.S. generic pharmaceuticals market. The introduction of Topiramate Extended-Release Capsules adds to the company's diverse portfolio of generic medications available to American healthcare providers and patients.

The launch demonstrates Lupin's commitment to expanding its footprint in key international markets while addressing important therapeutic needs through accessible generic pharmaceutical options.