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Actavis Finalizes Agreement Related To Asacol® HD Patent Challenge Litigation

DUBLIN, June 9, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has finalized its previously announced agreement with Zydus Pharmaceuticals USA Inc. to settle all outstanding patent litigation related to Zydus' generic version of Asacol ® HD (mesalamine) delayed-release tablets.  The terms of the agreement are unchanged from those disclosed by the companies in December 2013.

Under the terms of the agreement, Actavis will grant Zydus an exclusive 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 gain 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.

About Actavis

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 develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries.  The Company's North American branded pharmaceuticals business is focused principally in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in various stages of development.  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.

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