Eisai settles lenvatinib patent dispute with Dr. Reddy's

Eisai Co. has reached a settlement agreement with Dr. Reddy's Laboratories regarding patent infringement related to its oral tyrosine kinase inhibitor Lenvima (lenvatinib) in the United States. The settlement, signed on September 22, 2025, prevents Dr. Reddy's from selling generic lenvatinib until June 30, 2030, with certain exceptions, pending court approval.

The patents, U.S. Patent Nos. 10,407,393 and 11,186,547, cover high-purity lenvatinib. Similar settlements were previously reached with SUN Pharmaceutical Industries and SUN Pharmaceutical Industries Inc. on March 21, 2024, similarly restricting sales until June 30, 2030. In another related case, Shilpa Medicare Limited was blocked from obtaining FDA approval for generic lenvatinib until February 2036, although Shilpa is appealing this decision. Litigation against Torrent Pharmaceuticals remains ongoing.

Eisai reported net sales of JPY 229.6 bn for Lenvima in the U.S. for the fiscal year ending March 2025. This settlement is not expected to impact Eisai’s consolidated financial forecast for the fiscal year ending March 2026.