DUBLIN, July 7, 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 Roxane Laboratories, Inc., ("Roxane"), and in the U.S. District Court for the Central District of California against Watson Laboratories, Inc., ("Watson"), respectively, for infringement of certain of Shire's VYVANSE patents.
The lawsuits were initiated in response to Abbreviated New Drug Applications ("ANDAs") filed by each of Roxane and Watson 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 Roxane and Watson ANDAs before August 23, 2014, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.
Shire will provide details of any additional Paragraph IV certifications received advising of ANDA filings on VYVANSE, and any litigation that is subsequently initiated, in its periodic filings on Forms 10-Q and 10-K.
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 re
|SOURCE Shire plc|
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