On April 19, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that it has reached a settlement agreement with Hospira, Inc ("Hospira") (Press release, Eagle Pharmaceuticals, APR 19, 2022, View Source [SID1234612480]). Eagle had asserted two Orange Book-listed patents against Hospira related to its new drug application ("NDA") referencing BENDEKA. The settlement agreement provides that Hospira has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances.
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"We are pleased with the outcome of the settlement, as we continue to expand and vigorously defend the intellectual property around BENDEKA and our bendamustine franchise through patent enforcement and litigation," stated Scott Tarriff, President and Chief Executive Officer.
Eagle previously asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. ("Apotex") et al, Mylan Laboratories Limited ("Mylan"), and Fresenius Kabi USA, LLC ("Fresenius"), related to their respective abbreviated new drug applications (ANDA’s) 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. Prior to the appellate hearing, Eagle settled the litigation with Fresenius, which can market its products beginning in January 2029, or earlier based on certain circumstances. On August 13, 2021, the United States Court of Appeals for the Federal Circuit affirmed that the asserted patents were both valid and infringed. Apotex filed a petition for certiorari on December 14, 2021, which the Supreme Court denied on February 22, 2022. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
As previously reported, the U.S. Patent and Trademark Office granted Eagle U.S. Patent No. 11,103,483, entitled "Formulations of Bendamustine," which is listed in the Orange Book and expires in January 2031.