BRIEF—Unfavorable US patent decision for Astellas' Myrbetriq

The US District Court for the District of Delaware has issued a decision finding that Japanese drug major Astellas Pharma’s US Patent No 10,842 on Myrbetriq (mirabegron), which expires in March 2030, is invalid, the company confirmed today.

The ‘780 Patent covers extended-release drug formulations of mirabegron, including Myrbetriq.

This lawsuit was filed by Astellas in the US District Court for the District of Delaware requesting a judgement that certain generic pharmaceutical companies’ proposed generic versions of Myrbetriq infringe the ’780 Patent.

Astellas plans to appeal the decision to the US Court of Appeals for the Federal Circuit (CAFC).

Patents covering crystal forms and methods of using mirabegron, which were the subject of earlier litigation, remain valid and expire in May 2024.

Astellas does not anticipate the immediate launch of generic mirabegron.

This decision will have no impact on the financial forecasts of the current fiscal year ending March 31, 2024, Astellas noted.