On Thursday Astellas Pharma Inc. and its subsidiaries filed a case in the United States District Court for the District of Delaware against Apotex Inc. and its subsidiaries. The case concerns the Abbreviated New Drug Application (ANDA) filed by Apotex requesting permission for a generic version of Myrbetriq, specifically the extended release formulation for the drug.
Myrbetriq is used in the treatment of overactive bladder syndrome. This condition specifically requires an extended release formulation because the treatment needs to last throughout the overnight period in order to provide the necessary relief for patients.
In order to confirm quality of the extended release formulation, a statistical sampling of the product undergoes dissolution testing to ensure that a maximum percentage of the drug is dissolved in stomach conditions per hour and to ensure that the resulting ph from the drug does not exceed therapeutic levels.
Astellas asserted in its complaint that the ANDA submission by Apotex not only infringes upon the patents in suit regarding Myrbetriq, but also that the submission copied the testing methodology and charts down to the exact entries by Astellas.
Through the lawsuit, Astellas is seeking an injunction requiring the approval date for the Apotex be set no sooner than the patent expiration date as well as costs and damages. Astellas is represented by McCarter & English.
