Astellas takes to court over patent infringement of Myrbetriq in USA

Japanese drug major Astellas Pharma (TYO: 4503) and its subsidiaries jointly filed a lawsuit against Actavis Elizabeth and its affiliates, who filed an Abbreviated New Drug Application (ANDA) for a generic version of Astellas’ Myrbetriq(mirabegron) in the USA.

Astellas’ mirabegron product is protected by patents in the USA that cover the active compound, itself, its use for overactive bladder and polymorphic forms of the compound.

This lawsuit was filed with the US District Court for the District of Delaware on October 6, 2016 requesting, among other items, a judgment that Actavis has infringed the above patents and an order that the date of approval of Actavis’ ANDA not be earlier than the expiration of Astellas’ patents with respect to mirabegron, or any later date of exclusivity that Astellas is or becomes entitled to.