Eagle provides update on bendamustine intellectual property portfolio

Eagle Pharmaceuticals provided an update on its bendamustine intellectual property portfolio. On January 16 the U.S Court of Appeals for the Federal Circuit affirmed the previously announced decision by the U.S. District Court for the District of Delaware finding that the 505 drug applications referencing BELRAPZO filed by Slayback Pharma Liability Company and Apotex did not infringe Eagle’s previously issued ‘483 patent. Slayback, Apotex, and Baxter Healthcare launched their respective products in December of 2022. Eagle is also announcing that the U.S. Patent and Trademark Office has granted U.S. Patent Nos. 11844783 and 11872214 covering Eagle’s innovative bendamustine liquid formulations. The patents are listed in the Orange Book for both BENDEKA and BELRAPZO. On January 17 Eagle filed lawsuits asserting that 505 products referencing BELRAPZO marketed by Slayback, Apotex, and Baxter each infringe one or more claims of the newly issued ‘783 and ‘214 patents and requesting damages for any infringing sales of the parties’ respective accused products. Eagle intends to seek lost profits and other damages from any and all infringing sales of the defendants’ bendamustine products, as well as injunctive relief requiring the defendants to cease all sales of their infringing products until the expiration of the patents in 2031. Eagle cannot predict the timing or ultimate outcome of the litigation described above or the impact of this litigation on its business.