Actavis Confirms Appeals Court Issues Injunction Related to Generic Pulmicort
PARSIPPANY, N.J., May 24, 2013
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,
0.5and 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
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
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
(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )
SOURCE Actavis, Inc.
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