Actavis Launches Generic Pulmicort RESPULES

DUBLIN, Feb. 13, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has launched its generic version of AstraZeneca's Pulmicort RESPULES^® (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the United States District Court for the District of New Jersey that (i) United States Patent No. 7,524,834 is invalid, and (ii) AstraZeneca's request for a permanent injunction is denied.

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Actavis' Abbreviated New Drug Application ("ANDA") for its generic version of Pulmicort RESPULES^® received final approval from the U.S. Food and Drug Administration in August 2012.

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 (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.

Actavis 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; 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' Quarterly Report on Form 10-Q for the quarter ended September 30, 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