Drugmakers Dispute Scope of Orphan Drug Exclusivity

Drugmakers argued against broad orphan exclusivity for Eagle Pharmaceuticals’ Bendeka (bendamustine) in public comments to the FDA.

In June, the U.S. District Court for the District of Columbia ruled the FDA must grant Eagle seven years of orphan exclusivity for treatment of chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. The FDA later appealed the decision to the D.C. Circuit Court of Appeals and issued a request for stakeholder input. The agency said it would not approve any ANDAs referencing Bendeka during the exclusivity period, but it is still considering what to do about bendamustine applications that do not reference the branded drug.

Eagle argued in favor of broad exclusivity for its product, writing that it should apply to any applications containing bendamustine for the indications protected by the orphan exclusivity, even in cases where the reference drug is Mylan’s Treanda, the first approved bendamustine drug, whose orphan exclusivity has expired.