Navigation Links
Mylan Announces Clarinex(R) Settlement Agreement
Date:4/8/2009

PITTSBURGH, April 8 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex(R) allergy medication. This litigation has been pending in the U.S. District Court of New Jersey since September 2006.

Pursuant to the settlement, Mylan will have the right to market Desloratadine Tablets, 5 mg, in the U.S. on July 1, 2012, or earlier in certain circumstances, provided that the U.S. Food and Drug Administration (FDA) approves Mylan's abbreviated new drug application (ANDA). Mylan's product may be the prescription form or an over-the-counter version, depending on the status of Clarinex at the time. Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.

Desloratadine Tablets, 5 mg, had U.S. sales of approximately $284 million for the 12 months ending Dec. 31, 2008, according to IMS Health.

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement and marketing of the product. 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: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Announces Intention to Purchase Remaining Interest in Matrix Laboratories and Delist Matrix from Indian Stock Exchanges
2. Mylans Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease Inhibitor
3. Mylans Matrix Receives WHO Approval for First Generic, Heat-Stable Version of HIV Protease Inhibitor
4. Mylan Announces Transition of Chief Financial Officer
5. Mylan Vice Chairman and CEO Robert J. Coury to Ring NASDAQ Stock Market Opening Bell
6. Mylan Schedules Fourth Quarter Financial Results Conference Call and Live Webcast
7. Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER
8. Mylan Declares Quarterly Preferred Stock Dividend
9. Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD
10. Mylan Receives Final FDA Approval for Generic Version of Prilosec(R) Delayed-Release Capsules, 40 mg
11. U.S. Patent and Trademark Office Issues Mylans Specialty Division, Dey L.P., Three Additional Patents Protecting Perforomist(R) Inhalation Solution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... ... May 23, 2016 , ... ComplianceOnline, the leading governance, risk and compliance ... summit on September 15 and 16, 2016 in San Diego, CA. The two ... bearers will be one of the largest gatherings of medical device companies, suppliers, professionals ...
(Date:5/23/2016)... ... May 23, 2016 , ... ... today that nominations will be accepted May 23, 2016 through August 5, ... include the Information Security Executive® of the Year, which recognizes executives who ...
(Date:5/23/2016)... ... May 23, 2016 , ... Hadley ... worldwide for people who are blind or visually impaired, announces the election of ... President Charles E. Young. Hadley’s Board of Trustees retained Morris & Berger, a ...
(Date:5/23/2016)... ... 23, 2016 , ... Octo Consulting Group, a leading provider of innovative information ... announce they have recently won two awards from AFCEA International. Octo was selected ... Year. Additionally, Octo VP of Civilian Affairs, Naina Leo, was named a winner of ...
(Date:5/23/2016)... , ... May 23, 2016 , ... VitreosHealth is presenting ... 10, 2016 from 11:00 AM – 12:00 PM ET. To register, click ... start a proactive outreach program built on Big Data with a new predictive and ...
Breaking Medicine News(10 mins):
(Date:5/20/2016)... 2016 ReportsnReports.com adds Global ... Devices of its online business intelligence library. This ... current state of the Titrator industry. The report ... definitions, classifications, Specifications, applications and industry chain structure. ... Raw Material Suppliers, Equipment Suppliers, Manufacturing Cost Structure, ...
(Date:5/20/2016)... India , May 20, 2016 ... - Pipeline Review, H1 2016" market research report ... Plaque Psoriasis (Psoriasis Vulgaris), complete with comparative analysis ... mechanism of action (MoA), route of administration (RoA) ... featured news and press releases. It also reviews ...
(Date:5/19/2016)... According to a new market research report "Sunitinib Malate ... Germany , France , U.K., ... Japan )", published by MarketsandMarkets, The market is projected to ... from 2016 to 2021.      (Logo: http://photos.prnewswire.com/prnh/20160303/792302 ... through 26 Pages and in-depth TOC on "Sunitinib Malate ...
Breaking Medicine Technology: