Astellas Pharma and its subsidiaries have jointly filed a lawsuit against Actavis Elizabeth LLC and its affiliates, who have filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration for a generic version of Astellas’ Myrbetriq (mirabegron). Astellas’ mirabegron product is protected by US patents 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 Astellas’ US patents and an order that the date of approval of Actavis’ ANDA not be earlier than the expiration of these patents or any later date of exclusivity that Astellas is or becomes entitled to.

Astellas’ mirabegron has been marketed in more than 40 countries and areas since its commercial launch in Japan in 2011. In the US, Astellas Pharma US has been marketing mirabegron since 2012 under the brand name Myrbetriq.

In 2015, Actavis acquired Allergan in a deal worth approximately $70 billion and took the Allergan name for its corporate identity, but kept the Actavis name for the US and Canadian generic business.

In August 2016, Teva Pharmaceutical Industries acquired the generics business of Allergan in a $40.5 billion deal, which included the Actavis business in the US and Canada.

Source: Astellas