Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Xeloda(R) Cancer Treatment
Date:4/14/2009

Expects to qualify for 180 days of sole marketing exclusivity

PITTSBURGH, April 14 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda(R) Tablets, a chemotherapy treatment for breast and colorectal cancer.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final FDA approval is obtained. Hoffmann-La Roche filed a lawsuit April 8 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,472,949.

Xeloda Tablets, 150 mg and 500 mg, had approximately $447 million in sales for the 12 months ending Dec. 31, 2008, according to IMS Health. Currently, Mylan has 117 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to de
'/>"/>

SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Andrew G. Cuneo Joins Mylan as Vice President of Global Business Development
2. Mylan Announces Clarinex(R) Settlement Agreement
3. Mylan Announces Intention to Purchase Remaining Interest in Matrix Laboratories and Delist Matrix from Indian Stock Exchanges
4. Mylans Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease Inhibitor
5. Mylans Matrix Receives WHO Approval for First Generic, Heat-Stable Version of HIV Protease Inhibitor
6. Mylan Announces Transition of Chief Financial Officer
7. Mylan Vice Chairman and CEO Robert J. Coury to Ring NASDAQ Stock Market Opening Bell
8. Mylan Schedules Fourth Quarter Financial Results Conference Call and Live Webcast
9. Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER
10. Mylan Declares Quarterly Preferred Stock Dividend
11. Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... For those who want to build ... products are very practical. Top10BestSEOHosting.com today announces that ... the best ASP.NET hosting suppliers of this year. ... top web hosting provider for a long time, ... today. Recently proclaimed one of the fastest growing ...
(Date:8/27/2014)... 27, 2014 Philadelphia, PA. Inc. ... annual Inc. 500 list, an exclusive ranking of the ... most comprehensive look at the most important segment of ... who gained early exposure as members of the Inc. ... Pizza. , “Some of world’s greatest companies have ...
(Date:8/27/2014)... AR (PRWEB) August 27, 2014 Shawna's ... August 2014, is about Seed Digging, which a brand-new ... health therapy models, yet works to bring permanent healing ... with addictions and mental health disorders cured on a ... from their own minds and find incredible inner peace ...
(Date:8/27/2014)... Recently, iFitDress.com, a professional company of ... designs of romantic bridal gowns . To top ... price (up to 66 percent off) when buying the ... line has been updated with these new items. All ... hopes that all clients can gain an enjoyable shopping ...
(Date:8/27/2014)... 27, 2014 Seventy-three members of the ... celebrated the beginning of their careers as healthcare professionals ... 23. Students entering a four-year PharmD program traditionally receive ... welcome them into the profession as colleagues dedicated to ... at the Garrison Theater in Claremont, Calif., KGI President ...
Breaking Medicine News(10 mins):Health News:Top10BestSEOHosting.com Releases the Best ASP.NET Hosting Suppliers of This Year: Hostgator, Arvixe and FatCow 2Health News:Inc Magazine Unveils 33rd Annual List of America's Fastest-Growing Private Companies - the Inc. 500 2Health News:Shawna Burns, Counselor, Releases Debut Book, "Seed Digging," to Improve Lives of Children and Adults with Addictions and Mental Health Disorders 2Health News:Promotion For Romantic Bridal Gowns Launched By Professional Company iFitDress.com 2Health News:Founding Class of the KGI School of Pharmacy Formally Welcomed into the Profession at a Traditional White Coat Ceremony 2
... protect first responders, or people with weak immune systems ... and most people think of asthma, but new research ... firemen, emergency workers and other first responders. , They ... weakened by chemotherapy or HIV, according to scientists who,ve ...
... more than 30 years of experience in Public Safety and ... ... the global leader in,crisis information management technology, today announced that Paul,Crawford ... based in Boston, where he is responsible for ESi operations in,Massachusetts ...
... Need to Spearhead Talks with Doctors about ... New Treatment ... adopted "no seizures, no side effects" as a major goal for,people ... patients,with active epilepsy are informed by their doctors about treatment options.,The ...
... 3 ReBuilder Medical,Technologies, Inc. (Pink Sheets: RBRM), ... diabetic peripheral neuropathy, Molluscum,Contagiosum, and MRSA announces record ... ), "Corporate profits increased by 100% ... "Full disclosure will be released on our annual ...
... Dec. 3 LipoScience, Inc. is pleased to,announce the ... Directors., Mr. Landon has over 30 years of ... from active management, Mr. Landon,was Vice President & General ... functional responsibility for all of DuPont,s Medical,Products businesses, with ...
... of the leading contributors to a man,s inability to ... year look for a solution, many seek alternative treatments ... side effects. A new published study reveals that Prelox, ... antioxidant plant extract from the bark of the French ...
Cached Medicine News:Health News:Germ-Fighting Inhaler Could Fend Off Bioterror Agents 2Health News:Germ-Fighting Inhaler Could Fend Off Bioterror Agents 3Health News:ESi Announces Strategic New Hire in Boston 2Health News:Leading Epilepsy Groups Unveil New Survey Results Challenging Patients to Take Charge of Their Health 2Health News:Leading Epilepsy Groups Unveil New Survey Results Challenging Patients to Take Charge of Their Health 3Health News:Leading Epilepsy Groups Unveil New Survey Results Challenging Patients to Take Charge of Their Health 4Health News:ReBuilder Medical Technologies, Inc. Reports Doubled Profits for October 2Health News:Horphag's Prelox provides over-the-counter solution 2Health News:Horphag's Prelox provides over-the-counter solution 3
(Date:8/27/2014)... Aug. 27, 2014  CVS Caremark (NYSE: ... new clinical affiliation with MedStar Health, a leading health ... and the Washington, DC ... health care services for patients. Through this clinical affiliation, ... clinical support, medication counseling, chronic disease monitoring and wellness ...
(Date:8/27/2014)... NORWALK, Conn. , Aug. 27, 2014  UBM ... , a leading online community for medical imaging professionals, ... Association for Medical Imaging Management,s 2014 Annual Meeting ... the conference coverage: , 11 Principles ... management can lead to greater profitability. , ...
(Date:8/27/2014)... 27, 2014 /PRNewswire-iReach/ -- Emergency University , ... emergency medical training and response technologies, was awarded ... from the Department of Homeland Security and ... st Regional Support Command (RSC). The ... nationwide CPR/AED/First Aid training. The Army Reserve 81 ...
Breaking Medicine Technology:CVS Caremark Announces New Clinical Affiliation with MedStar Health 2CVS Caremark Announces New Clinical Affiliation with MedStar Health 3Diagnostic Imaging Covers Association for Medical Imaging Management (AHRA) 2014 Meeting 2Diagnostic Imaging Covers Association for Medical Imaging Management (AHRA) 2014 Meeting 3Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 2Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 3
... super series slit ... Examination through small ... fundus diagnostic capability, ... potential field of ...
... Volk's super ... biomicroscopy lenses. General ... Provide unprecedented fundus ... addressing maximum potential ...
Volk indirect lenses. General diagnosis / small pupil examinations....
Volk indirect lenses. General diagnosis & treatment....
Medicine Products: