Generic players had urged the court to adopt the same interpretation for the term “reduced food effect” across both the ‘189 and ‘451 patents. However, the court agreed with Astellas’ definition.
Capital noted that, until now, legal focus had been on the validity of the ‘780 patent. If that patent is deemed invalid, MSN and Ascent could launch their versions as early as November 2025. However, with the latest court ruling supporting Astellas’ definition in the ‘189 patent, generic companies now face an additional legal hurdle.
They have modelled Mirabegron (the generic version of Myrbetriq) sales at $140 million for Zydus in FY25/26 and $80–100 million for Lupin in the same period.
Zydus and Lupin launched the generic version of Myrbetriq at risk in April 2025.
People close to Lupin and Zydus have said this judgement does not alter anything for the companies and that the jury trial next year—when all patents will be challenged and litigated—will be important to watch.
(Edited by : Ajay Vaishnav)
