Eagle Pharma Receives New Patent For Bendamustine Rapid Infusion Product

(RTTNews) - Eagle Pharmaceuticals, Inc. (EGRX) Tuesday said the United States Patent and Trademark Office or USPTO has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes.

The patent issued today expires on March 15, 2033. This new patent, along with three previously issued patents, further expands and protects Eagle's bendamustine HCI intellectual property estate.

The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture.

The rapid infusion product candidate has received Orphan Drug Designations for both indications, and therefore may be eligible for seven years of exclusivity when approved.