On Jun 11, 2018, Eagle Pharmaceuticals, Inc. announced that the U.S. District Court for the District of Columbia (the Court) has issued a decision requiring the USFDA to grant seven years of orphan drug exclusivity (ODE) for BENDEKA™ (bendamustine hydrochloride injection), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation.
As a result of the Court’s decision, the FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in Dec 7, 2022. Moreover, the Company now does not expect generic TREANDA ® entrants into the market until 2022, rather than November 2019.
On April 27, 2016, Eagle sued FDA in the U.S. District Court for the District of Columbia alleging that FDA violated the Administrative Procedure Act (“APA”) when the Agency refused to grant 7-year of ODE to BENDEKA for Chronic Lymphocytic Leukemia (“CLL”) and indolent B-cell Non-Hodgkin Lymphoma (“NHL”) indications. Previously, FDA by letter of March 24, 2016 denied ODE because according to FDA, Eagle did not provide sufficient evidences than BENDEKA is superior to TREANDA. Thus, FDA claimed that Eagle had failed to meet the agency’s criteria for a demonstration of “clinical superiority”.