Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle Pharmaceuticals, Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C.) (Jun. 8, 2018). At issue following the Eagle decision was whether the exclusivity would block approval of generics to Treanda, a bendamustine product previously approved for the same orphan indications. FDA has decided that generics to Treanda are subject to Bendeka’s orphan exclusivity, and therefore (1) pending ANDAs will not receive final approval until December 7, 2022 (when Bendeka’s orphan exclusivity expires), and (2) ANDAs that were approved after December 7, 2015 (the date of Bendeka’s approval) will be converted to tentative approval until expiry of the exclusivity.
FDA’s announced position comes after a public comment period (docket here), and addresses a number of related legal issues, including the agency’s interpretation of the pre-FDA Reauthorization Act of 2017 (FDARA) version of the Orphan Drug Act. It would not be surprising for one of the affected generic sponsors to sue the agency on this decision. Bottom line: FDA’s letter decision is consistent with how FDA handled the orphan exclusivity the agency was directed to award Depomed for Gralise after a 2014 judicial decision, but will likely not provide a definitive resolution to these orphan exclusivity issues. That will have to wait on the outcome of the appeal of the underlying Eagle case, which is currently pending at the D.C. Circuit. Until then, however, FDA’s letter decision may have implications for other products that were – like Bendeka – impermissibly denied orphan exclusivity pre-FDARA. Stay tuned for a follow-up blog post on that subject next week.