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Actelion Settles REMS Dispute with Generic Drug Manufacturers

Robert F. Leibenluft

Robert F. Leibenluft,

Washington, D.C.

Lauren E. Battaglia

Lauren E. Battaglia,

Washington, D.C.

06 March 2014
Last week Actelion settled a lawsuit against two generic drug manufacturers regarding whether Actelion is required to supply those generic firms with samples of its drug Tracleer for use in the bioequivalence testing required as part of abbreviated new drug applications (ANDAs).  Tracleer is subject to various distribution restrictions as part of its Risk Evaluation and Mitigation Strategy (REMS) filed with the FDA, and therefore the generic manufacturers were not able to obtain these samples through a wholesaler as would ordinarily be the case.  In the lawsuit, Actelion asserted that it was under no obligation to do business with rivals and that, moreover, there were legitimate safety concerns associated with distributing Tracleer outside the terms of the REMS program.  The generic manufacturers in turn argued that Actelion was using the presence of the REMS to delay generic entry.

This settlement follows an October 2013 decision in the case by U.S. District Judge Noel Hillman denying Actelion’s motion for judgment on the pleadings and allowing the case to proceed to discovery.  However that ruling did not address the merits of the issues at the core of the lawsuit, and with this settlement it appears that these questions will remain unresolved for now.

Robert F. Leibenluft

Robert F. Leibenluft,

Washington, D.C.

Lauren E. Battaglia

Lauren E. Battaglia,

Washington, D.C.

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