Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for Bendeka (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.
As a result, and consistent with the order issued by the U.S. District Court for the District of Columbia (the Court) on June 8, 2018, the FDA will not approve any drug applications referencing Bendeka until the ODE expires in December 2022. Additionally, on July 7, 2018, the FDA filed a motion with the Court asking it to clarify that the order was not intended to affect applications referencing Treanda. Eagle continues to believe that an appropriate application of ODE would first allow generic Treanda entrants in December 2022, rather than November 2019, and expects to vigorously defend the scope of its exclusivity grant.
Bendeka is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen
Bendeka is low volume, rapid infusion version of bendamustine HCI. It is administered in a 50-mL admixture as an intravenous infusion for 10 minutes on days 1 and 2 of a 21- or 28-day cycle for 6 to 8 cycles.
Treanda is typically administered as an intravenous infusion in a 500-mL admixture for 30 to 60 minutes.