Astellas Reaches Settlement in Prograf Antitrust Case

Astellas Pharma has settled a class action lawsuit that accuses the brandmaker of filing a frivolous citizen petition and subsequent lawsuit solely to delay generic competition to its transplant drug Prograf.

The Japanese-based company and the pharmacies and wholesalers suing it told a Massachusetts district court judge Jan. 20 that they had reached a settlement in principal.

Details of the proposed settlement were not publicly available Wednesday, and Astellas said that it does not comment on pending litigation. Attorneys representing the plaintiffs did not respond to requests for comment by press time.  

In their 2011 complaint, the plaintiffs claimed that Astellas did everything it could to delay market entry of a cheaper generic competitor to its $74 million-a-month Prograf (tacrolimus). They noted, for example, that the brandmaker filed a citizen petition in September 2007 asking for more stringent bioequivalence testing for any proposed Prograf generics, just days before a new law allowing the FDA to ignore petitions it deemed frivolous took effect. Prior to that law, the agency would often delay generic approval until it could sort through such petitions, the plaintiffs said.   

The FDA rejected Astellas’ citizen petition in August 2009 and approved an ANDA on Prograf that Sandoz had filed in 2006 on the same day, according to the complaint.

Astellas filed a lawsuit seeking to block marketing of Sandoz’s generic the following day. The brandmaker argued at the time that transplant patients are vulnerable to small differences in tacrolimus concentrations between different manufacturers, which could lead to adverse outcomes. Astellas was denied its bid for a restraining order in the case.

Astellas’ actions effectively delayed generic Prograf entry by up to two years, during which time the brand drug enjoyed more than $1 billion in sales, the plaintiffs alleged. – Bryan Koenig