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Notice of the Settlement of Patent Infringement Litigation Related to Lenvatinib in the U.S.

Company Name: Ӱҵ. 
Representative: Haruo Naito 
Representative Corporate Officer and CEO 
(Code 4523 Tokyo Stock Exchange Prime Market)

Inquiries: Sayoko Sasaki
Vice President, Corporate Communications
Phone +81-3-3817-5120

 

 

Ӱҵ. (“the Company”) announced today that the Company had entered into a settlement agreement (the “Settlement”) with SUN Pharmaceutical Industries Ltd. and SUN Pharmaceutical Industries Inc. (collectively “SUN Pharma”) on March 21, 2024 regarding the lawsuit filed in the U.S. District Court for the District of New Jersey since November 2019 against generic drug manufacturers (SUN Pharma and Shilpa Medicare Limited (“Shilpa”)) for infringement of the patents relating to Lenvima® (generic name: lenvatinib mesylate), an orally available multiple receptor tyrosine kinase inhibitor discovered by the Company (U.S. Patent No. 10,407,393 and 11,186,547; "the Patents"). SUN Pharma and Shilpa had submitted an Abbreviated New Drug Application (“ANDA”) for a generic version of Lenvima. The settlement will be effective after the Consent Judgement is entered.

 

The Patents are directed to highly pure lenvatinib mesylate, and the Settlement is a major step forward in maximizing the value of Lenvima based on the intellectual property strategy of the Company. The terms and conditions of the Settlement are confidential at this time. The lawsuit against Shilpa is still pending, and the Company will announce any significant development in a timely manner.

 

Sales revenue of Lenvima in the U.S. for the fiscal year ended March 31, 2023 was 160.5 billion yen (US$1,185 million), and the forecast for the fiscal year ending March 31, 2024 is 197.0 billion yen (US$1,365 million). The Settlement is not supposed to have any impact on the consolidated financial forecasts for the fiscal year ended March 31, 2024.

 

 

 

* Please note that actual business results may change due to several factors since the above-mentioned forecasts were made based on information available as of today.

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