Navigation Links
Warner Chilcott Files Lawsuits for Infringement of DORYX(R) Patent

ST. DAVID'S, Bermuda, Dec. 23 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (Nasdaq: WCRX) announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. ("Mayne"), a subsidiary of Hospira, Inc., have filed lawsuits against each of Mutual Pharmaceutical Company, Inc. ("Mutual"), Mylan Pharmaceuticals Inc. ("Mylan") and Impax Laboratories, Inc. ("Impax") 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. Warner Chilcott markets and sells DORYX delayed-release tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne.

The lawsuits are in response to the submission of Abbreviated New Drug Applications ("ANDAs") to the U.S. Food and Drug Administration ("FDA") by each of Mutual, Mylan and Impax requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg delayed-release tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

About Warner Chilcott

Warner Chilcott is a specialty pharmaceutical company focused on developing, manufacturing, marketing and selling branded prescription pharmaceutical products in women's healthcare and dermatology in the U.S. WCRX-G.


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.

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 facility; 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, 2007; 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©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimers and Other Cognitive Disorders
2. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
3. Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer
4. FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
5. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
6. Further Clinical Testing of BZL101 in Advanced Breast Cancer Demonstrates Favorable Efficacy and Toxicity Profiles
7. Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
8. Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
9. AngioGenex Files Patent on First Small Molecule Id-Inhibitors for the Treatment of Cancer
10. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
11. Quark Pharmaceuticals Files Patent Application Covering Novel Chemical Modifications to its RNAi Molecules
Post Your Comments:
(Date:11/25/2015)... 25, 2015  Amgen (NASDAQ: AMGN ) today ... with the United States (U.S.) ... biosimilar candidate to Humira ® (adalimumab). Amgen believes ... to the FDA and represents Amgen,s first BLA submission ... Harper , M.D., executive vice president of Research and ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma Services ... investment of at least $15.8  Million to expand ... Wilmington, NC . The expansion will provide ... meet the growing demands of the pharmaceutical and ... site expansion will provide up to 40,000 square ...
(Date:11/25/2015)...  Henry Schein, Inc., the world,s largest provider of ... and animal health practitioners, will unveil at the Greater ... ConnectDental® Pavilion , which brings together for the first ... to help any practice or laboratory enter the digital ... schedule of experts appearing at the Pavilion. --> ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 2015 , ... The McHenry County law firm of Botto Gilbert Lancaster, ... Francisco J. Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented the claimant ... (2d) 130884WC. , According to court documents, Adcock testified that on May 10, 2010 ...
(Date:11/25/2015)... ... November 25, 2015 , ... SCOTTSDALE, AZ) - Today, ... specializing in both surgical and non-surgical treatments, announced the expansion of his private ... Plastic Surgery. , Highly trained and nationally recognized for his natural approach, ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical ... Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of its product ... intensive care units (totaling 30 beds) from May 2014 through October 2015 at a ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... that it has undertaken significant expansion of its current state of the art ... part of PharmaTech’s strategy to increase its manufacturing capacity as well as to ...
Breaking Medicine News(10 mins):