Eagle Pharmaceuticals Announces Three New Patents Issued for Bendeka

Eagle Pharmaceuticals, Inc. has announced that three additional patents have been issued related to Bendeka by the United States Patent and Trademark Office (USPTO). Patent numbers 9,579,397 and 9,579,398 and 9,579,399 will expire March 2033. The USPTO has now issued or allowed a total of 14 patents in the Bendeka family of patents expiring from 2026 to 2033.

The three newly issued patents will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange-Book) bringing Eagle’s total Orange Book listed patents for Bendeka to thirteen. Bendeka has also received Orphan Drug Designation from the FDA. Eagle continues to pursue obtaining a grant of Orphan Drug Exclusivity which would provide Bendeka exclusivity through December 2022.

"We continue to build the strength of our intellectual property portfolio protecting Bendeka. We see significant value in Bendeka well beyond 2020," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Several companies have unsuccessfully challenged one of the Orange Book listed patents (U.S. Patent No. 8,791,270) in both federal court and in the USPTO’s Patent Trial and Appeal Board (PTAB). Both the U.S. District Court for the District of Delaware and the PTAB have confirmed validity of the ‘270 patent which expires in 2026. The other patents have previously not been challenged.

The following table lists issued patents for liquid Eagle’s bendamustine hydrochloride formulations:

Under a February 2015 exclusive license agreement for Bendeka, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.