PARSIPPANY, N.J.,
Jan. 23, 2013
/PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI)
today confirmed that Actavis South Atlantic LLC, which was acquired
by Watson in October, has filed an
Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug
Administration (FDA) seeking approval to market Oxymorphone
Hydrochloride Extended-release Tablets. Actavis'
ANDA product is a generic version of the currently marketed
formulation of Endo Health Solutions' Opana® ER, which
is an opioid agonist indicated for the relief of moderate to severe
pain in patients requiring continuous around-the-clock opioid
treatment for an extended period of time.
Endo and Grunenthal GmbH filed suit against Actavis on
January 18, 2013, in the U.S.
District Court for the Southern District of New York seeking to prevent Actavis from
commercializing its ANDA product prior to the expiration of certain
U.S. patents. The lawsuit was filed under the provisions of
the Hatch-Waxman Act, resulting in a stay of
final FDA approval of Actavis' ANDA for up to 30 months
from the date the plaintiffs received notice of Actavis' ANDA
filing or until final resolution of the matter before the court,
whichever occurs sooner, subject to any other
exclusivities.
For the 12 months ending November
30, 2012, Opana® ER had total U.S. sales of
approximately $512 million according
to IMS Health data.
About Watson Pharmaceuticals,
Inc.
Watson Pharmaceuticals, Inc. (NYSE:
WPI) 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.
Watson is the world's
third-largest generics prescription drug manufacturer, with more
than 750 products marketed globally through operations in more than
60 countries. Watson's
global branded pharmaceutical business develops and markets
products principally in Urology and Women's Health, and
is committed to developing and marketing biosimilars products
in Women's Health, Oncology and other therapeutic categories.
In addition, Watson is the
fourth-largest U.S. generic pharmaceutical product distributor
through its Anda, Inc. business, and also develops and out-licenses
generic pharmaceutical products outside of the U.S. through its
Medis third-party business. Watson has announced that it will adopt a new
global name – Actavis – effective in 2013.
For press release and other company information, visit
Watson Pharmaceuticals' Web site at
http://www.watson.com.
Forward-Looking Statement
Statements contained in this press release that refer to
non-historical facts are forward-looking statements that reflect
Watson's current
perspective of existing information as of the date of this release.
It is important to note that Watson's goals and expectations are not
predictions of actual performance. Actual results may differ
materially from Watson's current expectations depending
upon a number of factors, risks and uncertainties affecting
Watson's business.
These factors include, among others, the impact of competitive
products and pricing; the timing and success of product launches;
difficulties predicting the timing our outcome of product
development efforts and regulatory agency approvals or actions, if
any; 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 Watson and its
third party manufacturers' facilities, products and/or businesses;
changes in the laws and regulations, including Medicare and
Medicaid, affecting among other things, pricing and reimbursement
of pharmaceutical products; and such other risks and uncertainties
detailed in Watson's
periodic public filings with the Securities and Exchange
Commission, including but not limited to Watson's Quarterly Report on Form 10-Q
for the quarter ended September 30,
2012 and Watson's Annual
Report on Form 10-K for the year ended December 31, 2011. Except as expressly
required by law, Watson disclaims
any intent or obligation to update these forward-looking
statements.
Opana® is a registered trademark of Endo
Pharmaceuticals, Inc.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Charlie Mayr
(862)
261-8030
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SOURCE Watson Pharmaceuticals, Inc.