Endo Begins Shipment of Generic CellCept®

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Dec 06, 2016, 07:30 ET

DUBLIN, Dec. 6, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping mycophenolate mofetil hydrochloride (HCl) for injection following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par's mycophenolate mofetil hydrochloride (HCl) for injection is the generic version of Roche's CellCept® and is the first and currently the only generic injectable available. According to IMS Health data, U.S. sales of injectable CellCept® were approximately $42 million for the 12 months ended October 31, 2016.

Mycophenolate mofetil hydrochloride (HCl) for injection is packaged in cartons of four 500 mg single dose vials.

CellCept® is a registered trademark of Hoffman-LaRoche Inc.

About Endo International plc

Endo International plc (NASDAQ / TSX: ENDP) 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. 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 the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR), and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo does not assume any 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 laws.

SOURCE Endo International plc