Astellas Pharma Inc., USA, has secured a favourable order from the United States District Court for the District of Delaware regarding the validity of its patent for a sustained-release formulation of mirabegron, marketed in the US as Myrbetriq.
The litigation involved a challenge by Zydus Lifesciences to the patent’s validity. The court’s order upholds Astellas’ intellectual property rights concerning the innovative formulation of the overactive bladder treatment.
While this order establishes the patent’s validity, the court has scheduled a consolidated jury trial in 2026 to address remaining issues, including potential patent infringement by Zydus Lifesciences, the quantum of damages, and any further invalidity arguments Zydus may present.
This ruling provides a significant boost to Astellas’ market exclusivity for Myrbetriq, a key product in its portfolio.
