Eisai settles patent litigation on lenvatinib in the USA

Japanese drugmaker Eisai (TYO: 4523) says it has entered into a settlement agreement with the US units of India’s Sun Pharmaceutical Industries (BSE: 524715) regarding the lawsuit filed in the US District Court for the District of New Jersey since November 2019 against generic drug manufacturers (Sun Pharma and Shilpa Medicare) for infringement of the patents relating to Lenvima (lenvatinib mesylate), an orally available multiple receptor tyrosine kinase inhibitor discovered by the company.

Sun Pharma and Shilpa had submitted an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug Lenvima. The settlement will be effective after the consent judgement is entered.

Eisai explained that 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.