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”.
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