Eagle Pharmaceuticals, Inc. announced Sept. 29 it has been granted a U.S. patent for its bendamustine hydrochloride (HCl) formulation administered in a 50 mL bag within 10 minutes, a rapid infusion product.
The rapid-infusion product is indicated for use in 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.
Teva will oversee all U.S. commercial activities for the product, while Eagle will secure all regulatory approvals, conduct post-approval clinical studies and initially supply the drug product to Teva.
The patent will expire March 15, 2033.
"Today’s patent issuance further strengthens our intellectual property for the bendamustine rapid infusion product, for which a new drug application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA),” Eagle Pharmaceuticals President and CEO Scott Tarriff said. “We believe that approval of and subsequent launch by Teva of this important product, along with royalty payments earned on sales and the potential for additional milestone payments, will expedite Eagle’s ability to deliver long term, sustainable growth.”
The Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA by the FDA is December 2015.
Eagle’s bendamustine product was the subject of a November 2014 clinical trial.