Endo Announces U.S. District Court Ruling Upholding OPANA® ER Intellectual Property
DUBLIN, May 2, 2016 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that the U.S. District Court for the Southern District of New York has issued an order upholding its August 2015 ruling in Endo's favor and confirming the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant OPANA® ER currently offered by Actavis, the U.S. generics business of Allergan plc, and the additional approved but not yet marketed generic version of the product developed by Roxane Laboratories.
In December 2012, Endo filed a patent infringement complaint against Actavis for patent infringement based on Actavis' sale of a non-crush-resistant generic version of OPANA® ER. In 2013, Endo filed suits against the following additional applicants for non-crush-resistant OPANA® ER: Par Pharmaceutical (now a subsidiary of Endo), Teva Pharmaceuticals, Mallinckrodt LLC, Sandoz, Roxane Laboratories and Ranbaxy Laboratories. The suits against Par Pharmaceutical and Mallinckrodt LLC were dismissed pursuant to settlements, and the suits against Teva Pharmaceuticals and Sandoz were dismissed based on those companies' demonstration to Endo that they are not seeking FDA approval to sell generic versions of non-crush-resistant OPANA® ER prior to the expiration of Endo's patents.
About Endo International plc
Endo International plc (NASDAQ: ENDP) (TSX: ENL) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward- looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward- looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the United States and Canada including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and with securities regulators in Canada on System for Electronic Document Analysis and Retrieval ("SEDAR") could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in the forward-looking statements contained in this press release. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.
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