Actavis Confirms Appeals Court Grants Injunction Pending Appeal Related to Generic Pulmicort RESPULES®

DUBLIN, March 12, 2015 /PRNewswire/ -- Actavis plc ACT today confirmed that the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort RESPULES^® (budesonide inhalation suspension) 0.25, 0.5 mg. 

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Under the ruling, Actavis' sales of generic Pulmicort have been enjoined pending the resolution of AstraZeneca's appeal before the Court.  The Court has set an expedited briefing schedule for the appeal, with expedited briefing to be concluded within 33 days.  The injunction does not address product shipped prior to its issuance.

Actavis' sales of generic Pulmicort had previously been enjoined under a temporary injunction granted by the Appeals Court on February 16, 2015.  The Appeals Court ruling followed the Feb. 13, 2015 launch of Actavis' product after the United States District Court for the District of New Jersey (i) found United States Patent No. 7,524,834 invalid, and (ii) denied AstraZeneca's request for a permanent injunction.

Pulmicort RESPULES^® is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.  For the 12 months ended June 30, 2014, total U.S. brand and generic sales of Pulmicort RESPULES^® were approximately $1.1 billion.

About Actavis
Actavis plc 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 future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

Pulmicort RESPULES^® is a registered trademark of the AstraZeneca group of companies.

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SOURCE Actavis plc