Astellas has filed a notice of application to the Patented Medicine (Notice of Compliance) Regulations in Canada against Sandoz Canada related to the filing of an abbreviated new drug submission (ANDS) by Sandoz for the Prograf, which is the generic version of Astellas tacrolimus hydrate.
Developed by Astellas, tacrolimus is used together with other medicines for preventing body from rejecting a heart, liver or kidney transplant.
In its application, Astellas has requested the Canadian Minister of Health not to issue marketing approval to Sandoz prior to the expiration of its patent for tacrolimus hydrate.