Eisai obtains favorable decision in patent infringement litigation related to lenvatinib in the U.S.

Eisai Co., Ltd. announced that the Company received a favorable decision on May 28, 2025 regarding the lawsuit filed in the U.S. District Court for the District of New Jersey (“the Court”) in November 2019 against generic drug manufacturer Shilpa Medicare Limited (“Shilpa”), which submitted an Abbreviated New Drug Application (“ANDA”) for a generic version of Lenvima, for infringement of U.S. Patent No. 11,186,547 ("the ‘547 Patent"). The ‘547 Patent relates to Lenvima® (generic name: lenvatinib mesylate), an orally available multiple receptor tyrosine kinase inhibitor discovered by the Company. As a result of this decision, Shilpa now is not able to receive approval from the FDA to sell its generic version of lenvatinib mesylate until after the ’547 Patent and related exclusivity expires in February 2036. The ‘547 Patent is directed to highly pure lenvatinib mesylate as found in the Company’s Lenvima product. The Court’s decision upheld the validity of the ‘547 Patent. This is a major step forward in maximizing the value of Lenvima for patients based on the intellectual property of the Company.