PARSIPPANY, N.J., May 24, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has granted a motion by AstraZeneca to enjoin Actavis from further distribution of its generic version of AstraZeneca's Pulmicort RESPULES® (budesonide inhalation suspension) 0.25, 0.5 mg products, pending resolution of AstraZeneca's appeal before the Court.
Actavis launched its generic product on April 1, 2013, following a ruling from the U.S. District Court for the District of New Jersey that Actavis' 0.25, 0.5 and 1 mg generic version of Pulmicort RESPULES® did not infringe United States Patent No. 7,524,834 (the '834 Patent) and that United States Patent No. 6,598,603 (the '603 Patent) was invalid. On April 2, 2013, the District Court issued a temporary restraining order prohibiting sales of Actavis' generic product to permit AstraZeneca an opportunity to seek injunctive relief with the Federal Circuit.
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 January 31, 2013, total U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.2 billion.
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Parsippany, New Jersey, USA.
Operating as Actavis Pharma, Actavis develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries.
Actavis Specialty Brands is Actavis' global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.
For press release and other company information, visit Actavis' Web site at http://www.actavis.com.
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 affecting Actavis' business. These factors include, among others, the inherent uncertainty associated with financial projections; the difficulty of predicting the timing or outcome of product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of the pending patent litigation, including potential appeals, and risks that an adverse outcome in such litigation and appeals could render Actavis liable for substantial damages; 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; and such 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 March 31, 2013 and Actavis' annual report on Form 10-K for the year ended December 31, 2012. 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, Inc.