Cadila Healthcare settles patent litigation with US-based Warner Chilcott

Cadila Healthcare Limited and its US subsidiary, Zydus Pharmaceuticals USA Inc, have entered into an agreement with Warner Chilcott Company, a subsidiary of Actavis Plc, 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.
 
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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 US 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 authorised generic version of Actavis' product beginning on July 1, 2016. Other terms of the settlement were not disclosed.