Eagle Pharma:Teva Requests Motion To Dismiss With Prejudice In Bendamustine Case

(RTTNews) - Eagle Pharmaceuticals Inc. (EGRX) announced that Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), has moved to dismiss with prejudice its first lawsuit alleging that Eagle's tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents, U.S. Patent No. 8,445,524. The case was filed in the United States District Court for the District of Delaware in October, 2013.

"We are pleased that this case is likely to resolve satisfactorily in the near future. This recent development begins to pave the way for the launch of our product," said Scott Tarriff, President and Chief Executive Officer.

Eagle's New Drug Application for its bendamustine product received tentative approval from the FDA on July 22, 2014. Due to orphan drug exclusivity held by Cephalon, the tentative approval will not convert to final approval until September 2015, unless, at an earlier date, Eagle is able to demonstrate that its bendamustine product, which itself has been granted an orphan drug designation by the FDA, is clinically superior to Cephalon's currently-marketed formulation.

The company noted that Cephalon recently filed a second lawsuit in the District of Delaware alleging that Eagle's bendamustine product infringes Cephalon's newly-issued U.S. Patent No. 8,791,270. That case remains pending.