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 Jersey, USA.
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.
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 forward-looking statements.
Lidoderm® is a registered trademark of Hind Health Care, Inc.