Warner Chilcott To Settle Patent Litigation On Zydus' Generic Asacol HD

(RTTNews) - Specialty pharmaceutical company Actavis plc(ACT), Wednesday said its unit Warner Chilcott Company, LLC, 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 or mesalamine delayed-release tablets.

Pursuant to the agreement, Warner Chilcott Company will grant Zydus a royalty-bearing license to market its generic Asacol HD from November 15, 2015 or earlier under certain circumstances, post the receipt by Zydus with regard to final approval from FDA on its Abbreviated New Drug Application for generic Asacol HD. In case if Zydus does not receive the required FDA approval by July 1, 2016, Zydus will be permitted to launch an authorized generic version of Actavis' product beginning on July 1, 2016. Certain other terms of the settlement were not divulged.