ST. DAVID'S, Bermuda, Dec 08, 2008 /PRNewswire-FirstCall via COMTEX/ -- Warner Chilcott Limited (WCRX:
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Last: 13.40+0.04+0.30%11:00am 12/09/2008Delayed quote data
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WCRX 13.40, +0.04, +0.3%) 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.
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