Zydus Loses Patent Battle Over Bladder Drug Myrbetriq In US, Jury Trial Set for 2026

“The innovator had filed a case against the Company in the matter pertaining to the validity of its US Patent No. 10,842,780 (‘the ‘780 patent’) held by the innovator, for a sustained release formulation of ‘mirabegron’ marketed in the US by the innovator under the brand name Myrbetriq®,” the company informed​.

While the court ruled in favour of Astellas on the validity of the patent, other aspects of the litigation—including alleged infringement, potential damages, and other invalidity theories—will be taken up in a consolidated jury trial scheduled for 2026.

No Immediate Financial Impact

Zydus clarified that the order does not result in any immediate financial penalty or claims.

“There is no material financial implication, as on the date of passing the order. We are evaluating the potential impact of the said order on the operations of the Company and the legal remedies available with the Company,” the company stated​.

The company also noted that the submission of the litigation update was delayed due to its global stakeholder footprint.

“The submission of information got delayed as the stakeholders are spread across global time zones,” said Dhaval N. Soni, Company Secretary and Compliance Officer at Zydus Lifesciences​

What’s Next?

With a consolidated trial scheduled for 2026, Zydus may consider pursuing further legal remedies or settlements. Meanwhile, the company continues to evaluate the impact of the court’s decision on its US market plans concerning the generic version of Myrbetriq®.