Company Announcements

Endo Comments on Non-Infringement Ruling in VASOSTRICT® Patent Litigation

DUBLIN, Aug. 31, 2021 /CNW/ -- Endo International plc ("Endo") (NASDAQ: ENDP) today commented on the United States District Court for the District of Delaware's non-infringement ruling in favor of Eagle Pharmaceuticals Inc. ("Eagle") in patent litigation regarding Eagle's abbreviated new drug application, or ANDA, for Par Sterile Products, LLC's VASOSTRICT® product.  Because the court found non-infringement of Endo's patents by Eagle's proposed product, it did not rule on the patents' validity.

"We are disappointed in today's ruling and respectfully disagree with the court's decision," said Matthew J. Maletta, Executive Vice President and Chief Legal Officer of Endo. "We note that the decision turned on the court's interpretation of conflicting appellate case law.  Specifically, the court stated that after expending significant effort, it remained unable to reconcile appellate case law governing the consideration of product testing data which differs from ANDA specifications.  We plan to address that important issue, among others, as we appeal today's decision and continue defending our intellectual property rights to VASOSTRICT®."

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may be considered "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Maletta and any statements relating to the status and outcome of litigation.  All forward-looking statements in this press release reflect Endo's current expectations of future events based on information available to Endo as of the date of this press release.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections, including with respect to the impact of the VASOSTRICT® patent litigation or any other litigation, investigation or settlement proceeding on our financial statements, including our cash flows from operations; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our ability to maintain compliance with our financial obligations under certain of our outstanding debt obligations, causing a downgrade of our debt and long-term corporate ratings (which could increase our cost of capital) and exposing us to potential events of default (if not cured or waived) under financial and operating covenants contained in our or our subsidiaries' outstanding indebtedness; our ability to incur additional borrowings under the covenants in our then-existing facilities or to obtain additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes, or to refinance our indebtedness; and/or a significant reduction in our short-term and long-term revenues and/or otherwise cause us to be unable to fund our operations and liquidity needs, such as future capital expenditures and payment of our indebtedness.  The occurrence or possibility of any such result may cause us to engage in a strategic review that ultimately results in our pursuing one or more significant corporate transactions or remedial measures.  Other risks and uncertainties include general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.  Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.  Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.

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SOURCE Endo International plc