Actavis Launches Generic Lidoderm®
PARSIPPANY, N.J., Sept. 16, 2013
PARSIPPANY, N.J., Sept. 16, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT)
today announced that it has launched a generic version of Lidoderm^®
(lidocaine topical patch 5%), as part of an exclusive settlement agreement
with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd. Actavis has
begun shipping the product and believes that, under applicable Hatch Waxman
rules, it is entitled to 180 days of marketing exclusivity. Lidoderm^® is a
local anesthetic indicated to relieve post-shingles pain.
"Thanks to this settlement agreement, consumers across the country are today
benefitting from generic competition on Lidoderm^® more than two years before
the product's patents expire," said Paul Bisaro, President and CEO of Actavis.
"We are pleased to be able to provide patients with this more affordable
treatment option, while offering yet another reminder of how patent
settlements have saved and continue to save consumers billions of dollars and
ensure the more-timely introduction of generic competition.
"The launch of generic Lidoderm^® also marks the culmination of a $44 million
expansion of our state-of-the-art pharmaceutical research, development and
manufacturing facility for transdermal and topical gel products in Salt Lake
City, Utah. Initiated in 2011, the expansion involved retrofitting
approximately 20,000 square feet of existing space, constructing approximately
17,000 square feet of new manufacturing space and adding approximately 300 new
jobs. These efforts ensured that we could maximize the talents and
capabilities of our Salt Lake team in driving not only this important launch,
but also planned future pipeline launches."
For the 12-month period ending May 31, 2013, Lidoderm^® had sales of
approximately $1.4 billion, 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. Actavis has global headquarters in Parsippany, New
Operating as Actavis Pharma, Actavis 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, risks and uncertainties
affecting Actavis' business. These factors include, among others, 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; the
difficulty of predicting how the FDA will interpret applicable Hatch Waxman
rules related to Actavis' entitlement to marketing exclusivity and the
possibility that an adverse interpretation of such rules could negatively
affect Actavis' marketing exclusivity; 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 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 June 30, 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
Lidoderm^® is a registered trademark of Hind Health Care, Inc.
SOURCE Actavis, Inc.
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