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Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
Date:7/8/2010

DUBLIN and PHILADELPHIA, July 8, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. (collectively "Zydus") for the infringement of U.S. Patent No. 6,773,720 (the '720 patent).

The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA) filed by Zydus seeking FDA approval to market and sell generic versions of Lialda(R) (mesalamine) prior to the expiration of the '720 patent.

Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving the Paragraph IV notification letter from Zydus, the FDA must refrain from approving Zydus' ANDA for 30 months, or until a district court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire in November 2012 unless terminated earlier.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as o
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SOURCE Shire plc
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