Actavis Confirms Generic Exelon® Patch Patent Challenge
PARSIPPANY, N.J., March 8, 2013
PARSIPPANY, N.J., March 8, 2013 /PRNewswire/ --Actavis, Inc. (NYSE: ACT)
today confirmed that it has filed with the U.S. Food and Drug Administration
(FDA) an amendment to its Abbreviated New Drug Application (ANDA) for
Rivastigmine Transdermal System to include the 13.3 mg per 24 hours dosage
strength. Actavis' ANDA product is a generic version of Novartis' Exelon^®
Patch, which is a prescription medicine used to treat people with mild to
moderate dementia associated with Alzheimer's or Parkinson's disease.
Novartis filed suit against Watson on March 7, 2013 in the United States
District Court for the District of Delaware seeking to prevent Actavis from
commercializing its 13.3 mg/ 24 hr strength 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 Watson's 13.3
mg/ 24 hr strength ANDA product for up to 30 months from the date that
Novartis received notice of Actavis' ANDA amendment filing or until final
resolution of the matter before the court, whichever occurs sooner, subject to
any other exclusivities.
Actavis previously filed an ANDA with the FDA seeking approval to market
Rivastigmine Transdermal System patch 4.6 mg/24 hr and 9.5 mg/24 hr, and was
subsequently sued by Novartis in November 2011. That application is subject
to a separate 30-month stay.
Based on available information, Watson believes it may be a "first applicant"
to file an ANDA for the generic version of each strength of Exelon^® Patch
and, should its ANDA be approved, may be entitled to 180 days of generic
For the twelve months ending January 31, 2013, Exelon^® had total U.S. sales
of approximately $521 million according to IMS Health data.
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, risks and uncertainties
affecting Actavis' business. These factors include, among others; the
difficulty of predicting the timing and outcome of the pending patent
litigation; the difficulty of predicting the timing or outcome of product
development efforts, including FDA and other regulatory agency approvals and
actions, if any; 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; changes in the laws and regulations; 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
Exelon^® is a registered trademark of Novartis AG.
(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )
SOURCE Actavis, Inc.
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