DUBLIN, May 7, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it will immediately re-launch its generic version of AstraZeneca's Pulmicort RESPULES® (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a decision from the United States Court of Appeals for the Federal Circuit to uphold a lower court's ruling that United States Patent No. 7,524,834 is invalid. The Appeals court also dissolved the injunction preventing Actavis from further distribution of its generic version of Pulmicort RESPULES® that was granted on March 12, 2015.
"We are pleased to be able to supply the market immediately with this product, and we are pleased that the Court of Appeals was able to work so swiftly to address this important matter," said Brent Saunders, CEO and President of Actavis.
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 December 31, 2014 total U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.2 billion.
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.
For more information, visit Actavis' website at www.actavis.com.
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 and Actavis' Irish statutory financial statements and related reports for the year ended December 31, 2014, furnished with the Securities and Exchange Commission on Form 8-K on March 27, 2015. 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.
SOURCE Actavis plc