EGRX - Eagle Pharmaceuticals Provides Update on Bendamustine Intellectual Property Portfolio | Benzinga
WOODCLIFF LAKE, N.J., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today provided an update on its bendamustine intellectual property portfolio.
On January 16, 2024, the United States Court of Appeals for the Federal Circuit affirmed the previously announced decision by the United States District Court for the District of Delaware finding that the 505(b)(2) drug applications referencing BELRAPZO® filed by Slayback Pharma Limited Liability Company ("Slayback")1 and Apotex Inc. and Apotex Corp. ("Apotex") did not infringe Eagle's previously issued ‘483 patent. Slayback, Apotex, and Baxter Healthcare Corporation ("Baxter") 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 (the "‘783 patent") and 11872214 (the "‘214 patent") covering Eagle's innovative bendamustine liquid formulations. The patents are listed in the Orange Book for both BENDEKA® and BELRAPZO.
On January 17, 2024, Eagle filed lawsuits asserting that 505(b)(2) 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.
"We are pleased to maximize our intellectual property for the bendamustine franchise and will continue to take appropriate steps to enforce our rights related to the newly issued patents," stated Michael Graves, Interim Principal Executive Officer and Interim Executive Chairman of the Board of Eagle.
Eagle cannot predict the timing or ultimate outcome of the litigation described above or the impact of this litigation on its business. In addition, Eagle made the allegations described above based only on information currently known to it. These allegations have not been fully litigated and the information and assumptions underlying these allegations may change after the date of hereof. Moreover, notwithstanding Eagle's allegations and its views on the merits of this litigation, litigation is inherently uncertain and there can be no guarantee that the court will agree with Eagle's allegations or interpretation of applicable regulations or laws, or that Eagle will otherwise prevail in this litigation. Accordingly, the allegations described above ...