Actavis Confirms Court Issues TRO Related to Generic Pulmicort RESPULES® Distribution
PARSIPPANY, N.J., April 3, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today confirmed that the United States District Court for the District of New Jersey has granted a motion by AstraZeneca seeking a temporary restraining order (TRO) to prevent Actavis from further distribution of its generic version of AstraZeneca's Pulmicort RESPULES® (budesonide inhalation suspension) 0.25, 0.5 mg products. Actavis' sales of generic Pulmicort RESPULES® have been enjoined until April 12, 2013 to permit AstraZeneca an opportunity to seek injunctive relief with the U.S. Court of Appeals for the Federal Circuit.
The District Court ruling followed the April 1, 2013 launch of Actavis' product after the District Court found 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.
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.
About Actavis
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.
Actavis is the world's third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets. Actavis Pharma also develops and out-licenses generic pharmaceutical products outside the U.S. through its Medis third-party business, the world's largest generic pharmaceutical out-licensing business. Medis has more than 300 customers globally, and offers a broad portfolio of more than 200 products.
Actavis Specialty Brands is the Company's global branded specialty pharmaceutical business, which develops and markets a portfolio of approximately 40 products principally in the United States and Canada that are focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands is committed to developing and marketing biosimilars products in Women's Health, Oncology and other therapeutic categories, and currently has a portfolio of 5 biosimilar products in development.
Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, with a capacity of approximately 44 billion units annually. Actavis Global Operations also includes Anda, Inc., the fourth-largest U.S. generic pharmaceutical product distributor in the United States.
For press release and other company information, visit Actavis' Web site at http://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 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' 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.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Charlie Mayr
(862) 261-8030
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SOURCE Actavis, Inc.