Cadila Healthcare and Zydus Pharmaceuticals Inc., have entered into an agreement in principle with Warner Chileott Company LLC to settle all outstanding patent litigation related to 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 will grant Cadila and Zydus a royalty-bearing license to market a generic version of Asacol HD beginning on November 15, 2015 or earlier under certain circumstances, following receipt by Zydus of final approval from the US FDA of its 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 Asacol HD beginning on July 1, 2016. Other terms of the settlement were not disclosed.