The terms of the agreement are unchanged from those disclosed by the two firms in December 2013.
As part of the deal, Actavis will grant Zydus an exclusive license to market its generic Asacol HD beginning on 15 November 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.
In case, if Zydus does not gain FDA approval of its generic Asacol HD by 01 July 2016, the company will be permitted to launch an authorized generic version of Actavis’ product beginning on 01 July 2016.
Actavis is focused in developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.