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Actavis Announces Tentative Agreement Related To AsacolA® HD Patent Challenge Litigation

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.

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 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.

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