DUBLIN, Dec. 11, 2013 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading specialty pharmaceutical company, today announced that it its subsidiary, Warner Chilcott Company, LLC, has entered into an agreement in principle with Zydus Pharmaceuticals USA Inc. and Cadila Healthcare Limited to settle all outstanding patent litigation related to Zydus' generic version of Asacol® HD (mesalamine) delayed-release tablets. The agreement remains subject to preparation and execution of definitive documentation.
Under the terms of the agreement in principle, Warner Chilcott Company will grant Zydus a royalty-bearing license to market its generic Asacol® HD beginning on November 15, 2015 or earlier under certain circumstances, following receipt by Zydus of final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Asacol® HD.
Alternatively, if Zydus does not receive FDA approval of its generic Asacol® HD by July 1, 2016, Zydus will be permitted to launch an authorized generic version of Actavis' product beginning on July 1, 2016. Other terms of the settlement were not disclosed.
Actavis plc (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 Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.
Actavis markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries, and operates a global branded specialty pharmaceutical business focused in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories. Actavis 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 http://www.actavis.com.
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; risks that the parties to the agreement in principle to settle the pending patent litigation concerning Asacol® HD fail to negotiate and execute definitive documentation resolving the litigation; 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 plc's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
SOURCE Actavis plc