Eagle Pharmaceuticals Secures Additional Patent for Bendamustine Franchise


LAKE WOODCLIFF, NJ – (COMMERCIAL THREAD) – Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the United States Patent and Trademark Office has granted the Company U.S. Patent No. 11,103 483, titled “Bendamustine Formulations”. Eagle Submits’ 483 Patent for U.S. Food and Drug Administration Orange Book Listing for Both BENDEKA® and BELRAPZO®.

Eagle had claimed several patents listed in the Orange Book against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited and Fresenius Kabi USA, LLC, related to their respective abridged new drug applications referencing BENDEKA. On July 6, 2020, the Delaware District Court found these claimed patents to be both valid and infringed. Apotex, Mylan and Fresenius appealed against this decision. Prior to the appeal hearing, Eagle settled the Fresenius litigation. On August 13, 2021, the United States Court of Appeals for the Federal Circuit ruled that the claimed patents were both valid and infringed. The claimed patents and the ‘483 patent expire in 2031.

“We are delighted that this appeal decision, along with the newly issued patent, continues to strengthen Eagle’s intellectual property rights for BENDEKA and BELRAPZO,” said Scott Tarriff, CEO of Eagle Pharmaceuticals.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with expertise in research and development, clinical, manufacturing and commercial. Eagle is committed to developing innovative medicines that result in significant improvements in the lives of patients. Eagle’s marketed products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS / metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas in multiple disease states. Additional information is available on the Eagle website at www.eagleus.com.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts. Words and expressions such as “planned”, “ahead”, “will”, “would”, “could”, “remain”, “potential”, “prepare”, “foresee”, “believe”, “plan”, “Near future”, “belief”, “direction” and similar expressions are intended to identify forward-looking statements. Such statements include, but are not limited to, statements regarding the submission of U.S. Patent No. 11,103,483 for inclusion in the United States Food and Drug Administration orange book for BENDEKA and BELRAPZO; and statements regarding the strength of the Company’s intellectual property rights for BENDEKA and BELRAPZO. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed, implied or projected by forward-looking information. ns. These risks and uncertainties include, but are not limited to: the impacts of the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review or any other disruption or delay any ongoing or future litigation; delay or failure in obtaining regulatory approval of the Company’s product candidates and compliance with the FDA, EMA and other government regulations applicable to product approvals; the outcome of a dispute involving one of its products or which may have an impact on one of its products; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; the risks inherent in drug development and the conduct of clinical trials; and the risks and uncertainties identified in the “Risk Factors” section of the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on 5 March 2021, as updated by the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, filed with the SEC on May 10, 2021 and August 9, 2021, respectively, and its other subsequent filings with the SECOND. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company assumes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.


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