Actavis Confirms Court Issues TRO Related to Generic Pulmicort RESPULES®
PARSIPPANY, N.J., April 3, 2013
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
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.
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,
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
For press release and other company information, visit Actavis' Web site at
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
(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )
SOURCE Actavis, Inc.
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