DUBLIN, July 1, 2011 /PRNewswire/ —
Shire plc (LSE: SHP, NASDAQ:
SHPGY), the global specialty biopharmaceutical company,
announces that it has filed lawsuits in the U.S. District Court for
the District of New Jersey against each of Amneal Pharmaceuticals,
LLC (“Amneal”) and Sandoz, Inc. (“Sandoz”) for infringement of
certain of Shire’s VYVANSE patents.
The lawsuits were initiated in response to Abbreviated New Drug
Applications (“ANDAs”) filed by Amneal and Sandoz seeking FDA
approval to market and sell generic versions of all currently
approved doses of VYVANSE.
Under the Hatch-Waxman Act, the FDA must refrain from approving
the Sandoz and Amneal ANDAs for 30 months (expiring August 23, 2014), or until a district court
decision finding that the patents are invalid or not infringed,
whichever occurs earlier.
Notes to editors
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 opportunities
in other therapeutic areas to the extent they arise through
acquisitions. Shire’s in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire
believes that a carefully selected and balanced portfolio of
products with strategically aligned and relatively small-scale
sales forces will deliver strong results.
For further information on Shire, please visit the Company’s
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