On August 31, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,103,483, entitled "Formulations of Bendamustine (Press release, Eagle Pharmaceuticals, AUG 31, 2021, View Source [SID1234587030])." Eagle is submitting the ‘483 patent for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA and BELRAPZO.

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Eagle had asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited, and Fresenius Kabi USA, LLC, related to their respective abbreviated new drug applications referencing BENDEKA. On July 6, 2020, the District Court for the District of Delaware had held these asserted patents both valid and infringed. Apotex, Mylan, and Fresenius appealed this ruling. Previous to the appellate hearing, Eagle settled the Fresenius litigation. On August 13, 2021, the United States Court of Appeals for the Federal Circuit affirmed that the asserted patents were both valid and infringed. Both the asserted patents and the ‘483 patent expire in 2031.

"We are pleased that this appellate decision, as well as the newly issued patent, continue to strengthen Eagle’s intellectual property rights for both BENDEKA and BELRAPZO," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.