Actavis Confirms Appeals Court Upholds Lo Loestrin® Fe Patent

Oct 23, 2014, 08:00 ET from Actavis plc

DUBLIN, Oct. 23, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has upheld a lower court ruling that found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals, Inc. and Amneal Pharmaceuticals' Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).  Lo Loestrin® Fe is a prescription birth control pill used for the prevention of pregnancy.  

Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

As a result of the Court's ruling, Lupin and Amneal are prevented from launching their generic versions of Lo Loestrin Fe® until after the '984 Patent expires on February 2, 2029.

About Actavis Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world. 

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.  The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.  Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.com.

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release.  It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' business. These factors include, among others; the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on form 10-K for the year ended December 31, 2013, Quarterly Report on form 10-Q for the quarter ended June 30, 2014 and from time to time in Actavis' other investor communications.  Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:

Investors:

Lisa DeFrancesco

(862) 261-7152

Media:

Charlie Mayr

(862) 261-8030

David Belian

(862) 261-8141

SOURCE Actavis plc



RELATED LINKS

http://www.actavis.com