Mylan Announces Clarinex(R) Settlement AgreementPITTSBURGH,
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
® 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.
04/08/2009
CONTACT: Michael Laffin (Media), +1-724-514-1968 or Dan Crookshank
(Investors), +1-724-514-1813, both of Mylan Inc.
/Web Site: http://www.mylan.com
(MYL)