Zydus Cadila settles Asacol patent litigation in USA

Zydus Cadila, one of India’s largest privately-held pharmaceuticals companies, and affiliate Zydus Pharmaceuticals (USA) have entered into an agreement in principle with Warner Chilcott, now a subsidiary of generics major Actavis (NYSE: ACT), settle all outstanding patent litigation related to ulcerative colitis drug Asacol HD (mesalamine) delayed-release tablets.

The deal remains subject to preparation and execution of definitive documentation. Under the terms of the agreement in principle, Warner Chilcott 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 Food and Drug Administration of its Abbreviated New Drug Application for a generic version of Asacol HD.

Alternatively, if Zydus does not receive FDA approval by July 1, 2016, Zydus will be permitted to launch an authorized generic version beginning on July 1, 2016. Other terms of the settlement were not disclosed.