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District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R)
Date:3/4/2010

PHILADELPHIA, March 4, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as an NCE within the meaning of the governing statutes and regulations. As an NCE, VYVANSE is entitled t
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