Navigation Links
Warner Chilcott Files New Lawsuit for Infringement of DORYX(R) Patent
Date:5/1/2009

HAMILTON, Bermuda, May 1 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (Nasdaq: WCRX) announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. ("Mayne") have filed a second lawsuit against Mylan Pharmaceuticals Inc. and Mylan Inc. ("Mylan") in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic. The lawsuit is in response to the submission of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") by Mylan requesting approval to manufacture and sell a generic version of DORYX 150 mg delayed-release tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott previously announced, in December 2008, the filing of a lawsuit against Mylan in response to Mylan's submission of an ANDA requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg delayed-release tablets. Warner Chilcott markets and sells DORYX delayed-release tablets in 150, 100 and 75 mg strengths in the United States under a license agreement with Mayne.

Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights. Warner Chilcott believes that the FDA will stay approval of Mylan's generic version of DORYX 150 mg delayed-release tablets for up to 30 months, while the case is pending in the District Court.

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.

Read more on www.warnerchilcott.com.

Warner Chilcott's Forward Looking Statements:

This press release contains forward-looking statements, including statements concerning our operations, our anticipated economic performance and financial condition, and our business plans and growth strategy and 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.

The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon whom we may rely for some of our products or our own manufacturing facilities; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2008; and other risks detailed from time-to-time in our public filings, financial statements and other investor communications.

We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.


'/>"/>
SOURCE Warner Chilcott Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. HBO, Warner Bros. Employee Initiatives and the Alzheimers Association, California Southland Chapter Present a Free, Public, Advance Screening of THE ALZHEIMERS PROJECT: Caregivers
2. Warner Chilcott Announces Earnings Release Date and Conference Call For First Quarter 2009 Financial Results
3. Warner Chilcott Files New Lawsuit for Infringement of DORYX(R) Patent
4. Warner Chilcott Announces Receipt of FDA Response to Citizen Petition
5. Warner Chilcott Announces Receipt of Paragraph IV Certification Notice
6. Virginia Faith Leaders Call on Senators Webb & Warner to Support Legislation to Protect Kids from Tobacco
7. Virginia Faith Leaders Call on Sens. Webb & Warner to Support Legislation to Protect Kids From Tobacco
8. Warner Chilcott Reports Operating Results for the Quarter and Year Ended December 31, 2008
9. Warner Chilcott Announces 2009 Financial Guidance
10. Warner Chilcott Announces 2009 Financial Guidance Conference Call
11. Warner Chilcott Files New Lawsuit for Infringement of DORYX(R) Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... On ... as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle ... honor of the city’s history as home to some of the world’s leading providers ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... Forecast to 2022" report to their offering. ... the patients with kidney failure, it replaces the function of ... patient,s blood and thus the treatment helps to keep the ... balance. Increasing number of ESRD patients & ...
Breaking Medicine Technology: