Endo Begins Shipment of Generic ZETIA®

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Dec 12, 2016, 07:30 ET

DUBLIN, Dec. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck's ZETIA®. Par Pharmaceutical is the marketer and distributor of the product in the U.S., and is entitled to Hatch-Waxman generic marketing exclusivity based on the first-to-file ANDA status of its licensing partners, Glenmark Pharmaceuticals, Inc., USA, with whom Par will share profits.

"We, along with our partners at Glenmark, are proud to be able to offer patients managing their cholesterol levels the first generic version of ZETIA®," said Tony Pera, President of Par Pharmaceutical. "Par remains committed to providing patients access to high quality and affordable medicines."

"Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world," said Robert Matsuk, President of North America and Global API. "Our partnership with Endo to bring the first generic version of ZETIA® to market only underscores our joint commitment to bridging the gap between patients and the medicines they need most."

ZETIA® is indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.

According to IMS Health data, U.S. sales of ZETIA® are approximately $2.614 billion for the 12 months ended September 30, 2016.

Important Safety Information
ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. ZETIA can be taken alone or with a statin. Statins should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with liver problems. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA alone is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment.

Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. In clinical studies, patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and tiredness.

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.

About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of respiratory disease, oncology and immunology. Headquartered in Mumbai, India, with U.S. Headquarters in Mahwah, NJ. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com/usa.

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