ST. DAVID'S, Bermuda, Dec. 8 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (Nasdaq: WCRX) announced today that one of the Company's subsidiaries and Hospira, Inc. ('Hospira') have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. ('Mutual') and Mylan Pharmaceuticals Inc. ('Mylan') advising that each such company has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets.
DORYX, which the Company markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Hospira's subsidiary, Mayne Pharma Limited ('Mayne'), is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the '161 Patent') which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.
The Company and Mayne are currently reviewing the detail of the Paragraph IV Certification Notices from Mutual and Mylan and continue to have full confidence in the intellectual property protecting DORYX.
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S. pharmaceuticals market. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G
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Warner Chilcott's Forward Looking Statements:
This press release contains forward-looking statements, including statements concerning our product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words 'may,' 'might,' 'will,' 'should,' 'estimate,' 'project,' 'plan,' 'anticipate,' 'expect,' intend,' 'outlook,' 'believe' and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
