PARSIPPANY, N.J., April 26, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT), a leading specialty pharmaceutical company, today announced that it has entered into an agreement with Purdue Pharma to settle all outstanding patent litigation related to Actavis' generic version of the currently marketed abuse-deterrent formulation of OxyContin®.
Under the terms of the agreement, Actavis will be licensed to market a specified number of bottles of its generic OxyContin® beginning on January 1, 2014. Launch of Actavis' product is contingent upon the Company receiving final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic OxyContin®.
Alternatively, if Actavis is unable to gain FDA approval of its generic OxyContin® prior to September 1, 2014, the Company will be permitted to launch a specified number of bottles of an authorized generic version of Purdue's abuse-deterrent product beginning in October 2014.
Actavis anticipates that the agreement will represent more than $100 million in combined gross profit in 2014 and 2015, more heavily weighted to 2014. The agreement is expected to result in a more modest contribution from 2016 through 2019. Other terms of the settlement were not disclosed.
"The agreement provides a date certain launch that eliminates the risk of current and future litigation related to all versions of OxyContin®," said Paul Bisaro, President and CEO of Actavis. "It also eliminates the uncertainty surrounding FDA review and approval of generic versions of abuse deterrent products. Consumers and Actavis shareholders will now benefit from the distribution of product beginning in 2014."
OxyContin® had U.S. sales of approximately $2.8 billion for the twelve month period ending January 31, 2013 according to IMS Health.
About Actavis, Inc.
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, Switzerland.
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 States.
Forward-Looking Statement 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 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; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities or agencies; 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, 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' 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.