Home Commercial book Eagle Pharmaceuticals reaches settlement agreement with Hospira regarding BENDEKA® (bendamustine hydrochloride) through January 17, 2028

Eagle Pharmaceuticals reaches settlement agreement with Hospira regarding BENDEKA® (bendamustine hydrochloride) through January 17, 2028


Eagle Pharmaceuticals, Inc.

WOODCLIFF LAKE, NJ, April 19, 2022 (GLOBE NEWSWIRE) — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has reached a settlement agreement with Hospira, Inc ( “Hospira”). Eagle had asserted two patents in the Orange Book against Hospira related to its New Drug Application (“NDA”) referencing BENDEKA®. The settlement agreement provides that Hospira has the right to commercialize its product beginning January 17, 2028 or earlier depending on certain circumstances.

“We are pleased with the outcome of the settlement, as we continue to vigorously develop and defend the intellectual property around BENDEKA and our bendamustine franchise through patent enforcement and litigation,” said Scott Tarriff, President. and CEO.

Eagle has previously asserted several patents listed in the Orange Book against Slayback Pharma LLC, Apotex Inc. (“Apotex”) et al, Mylan Laboratories Limited (“Mylan”) and Fresenius Kabi USA, LLC (“Fresenius”), related to their abbreviated new drug applications (ANDAs) referring to BENDEKA. On July 6, 2020, the District Court for the District of Delaware found these claimed patents both valid and infringed. Apotex, Mylan and Fresenius have appealed this decision. Prior to the appeal hearing, Eagle settled the dispute with Fresenius, which may market its products from January 2029, or earlier depending on certain circumstances. On August 13, 2021, the United States Court of Appeals for the Federal Circuit affirmed that the claimed patents are 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 Federal Trade Commission and the United States Department of Justice. United.

As previously reported, the U.S. Patent and Trademark Office has granted Eagle U.S. Patent No. 11,103,483, titled “Formulations of Bendamustine,” which is listed in the Orange Book and expires January 2031.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in the lives of patients. Eagle’s marketed products include Vasopressin Injection, PEMFEXY™, RYANODEX®BENDEKA®BELRAPZO®, TREAKISYM (Japan), and its oncology and CNS/metabolic critical care pipeline includes product candidates that have 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 information 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 phrases such as “expected”, “forward”, “will”, “could”, “could”, “stay”, “potential”, “prepare”, “planned”, “believe”, “plan” , “near future”, “belief”, “orientation”, “opportunity”, “estimate” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events such as: statements regarding the resolution of a patent litigation and any related settlement terms, including the date of entry on the market and the possibility of earlier market entry under certain circumstances and the submission of the settlement agreement to the United States Federal Trade Commission and the United States Department of Justice for review; statements regarding the strength of the Company’s intellectual property rights for BENDEKA and BELRAPZO and the defense and enforcement of intellectual property rights; the timing, extent or likelihood and timing of regulatory filings and FDA approvals for the Company’s product candidates; and the ability of the company’s management team to execute the company’s strategy and create shareholder value. 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 the forward-looking information. . and statements. These risks and uncertainties include, but are not limited to: the impacts of the COVID-19 pandemic and geopolitical events such as the conflict in Ukraine, including disruption or impact on sales of the Company’s marketed products , interruptions or other adverse effects on trials, delays in regulatory review, disruptions in manufacturing and supply chain, adverse effects on health systems, disruption of partner operations third parties of the Company and the disruption of the global economy, and the overall impact of the COVID-19 pandemic or other events on the Company’s business, financial condition and results of operations; whether the Company will incur unexpected expenses or liabilities or other market factors; whether the Company will successfully implement its development plan for its product candidates; delay or inability to obtain regulatory approval for product candidates of the Company or its partners; whether the Company can successfully commercialize and commercialize its product candidates; the success of the Company’s relations with its partners; the availability and price of products and materials from third parties; the outcome of a dispute involving one of its products or which may have an impact on one of the Company’s products; successful compliance with FDA and other applicable government regulations for product approvals, manufacturing facilities, products and/or companies; general economic conditions, including the potential adverse effects of public health concerns, including the COVID-19 pandemic and geopolitical events, on economic activity and financial market performance generally; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential competition from generic entrants to the market; risks inherent in the early stages of drug development and the conduct of clinical trials; and factors in addition to the foregoing which may affect the Company’s expectations, including, among others, any potential business development transactions, acquisitions, restructurings or legal settlements, in addition to any unforeseen factors, which could cause the results and actual results of the Company to differ materially; 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, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2022, and its other subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements. 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 undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
Onsite Communications, Inc.
Such. : 212-452-2793
Email: [email protected]