Tokyo, Japan, October 7, 2016 - Astellas Pharma Inc. (TSE: 4503; President and CEO: Yoshihiko Hatanaka, “Astellas”) and its subsidiaries jointly filed a lawsuit against Actavis Elizabeth LLC and its affiliates (“Actavis”), who filed an abbreviated new drug application (ANDA) for a generic version of Astellas’ mirabegron (generic name) product sold under the trademark Myrbetriq® in the United States. Astellas’ mirabegron product is protected by patents in the U.S. that cover the active compound, itself, its use for overactive bladder and polymorphic forms of the compound.
This lawsuit was filed with the United States District Court for the District of Delaware on October 6, 2016 (EST) 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.
Mirabegron was invented by Astellas and has been marketed in more than 40 countries and areas since its commercial launch in Japan in 2011. In the U.S., Astellas Pharma US, Inc. has been marketing mirabegron since 2012 under the brand name Myrbetriq®.
This lawsuit will not materially affect Astellas’ financial results of the current fiscal year ending March 31, 2017.