Zydus Loses Patent Battle Over Bladder Drug Myrbetriq In US, Jury Trial Set for 2026
New Delhi: Indian drugmaker Zydus Lifesciences has received a legal setback in the United States after the District Court of Delaware ruled in favour of Astellas Pharma Inc. in a patent litigation related to the widely marketed urology drug Myrbetriq (mirabegron sustained-release tablets).
In a regulatory filing to the BSE and NSE dated April 17, 2025, Zydus disclosed that the ruling upheld the validity of Astellas' U.S. Patent No. 10,842,780 (“the ‘780 patent”) pertaining to the sustained release formulation of mirabegron, which is used for treating overactive bladder (OAB).
“The Court passed an order in favour of the innovator on the validity of the ‘780 patent. Infringement of the ’780 patent, damages, and any additional invalidity theories will be litigated at a consolidated jury trial in 2026,” Zydus said in the exchange filing.
Background of the Case
The patent battle centers on the formulation of Myrbetriq®, a popular drug sold in the US by Astellas Pharma Inc. for the treatment of overactive bladder. Zydus had challenged the validity of the ‘780 patent held by the innovator company. The litigation was heard by the United States District Court for the District of Delaware.
“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®.
