Cadila Healthcare inks pact with Warner Chilcott to settle patent dispute

NEW DELHI: Cadila Healthcare said it along with Zydus Pharmaceuticals (USA) Inc, have entered into an agreement with Warner Chilcott Company 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, Cadila Healthcare said in a statement.

As part of the agreement, 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 USFDA of its ANDA for generic Asacol HD, the company said.

"Alternatively, if Zydus does not receive FDA approval of its generic Asacol HD by July 1, 2016, Zydus will be permitted to launch an authorised generic version of Asacol HD beginning on July 1, 2016," it added.

Asacol is used to treat ulcerative colitis, proctitis and proctosigmoiditis.

Shares of Cadila Healthcare today closed at Rs 725.45 apiece on the BSE, down 1.04 per cent from previous close.