Actavis has finalised 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 licence 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 (US 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 authorised generic version of Actavis' product beginning on July 1, 2016. Other terms of the settlement were not disclosed.