Supplier News Breaks Archives
Actavis wraps up agreement on Asacol HD patent litigation
June 10th, 2014
DUBLIN, Ireland – Actavis plc has finalized its previously announced agreement with Zydus Pharmaceuticals USA Inc. to settle all outstanding patent litigation related to Zydus' generic version of Asacol HD delayed-release tablets.
Actavis said late Monday that the terms of the agreement are unchanged from those disclosed by the companies in December.
Under the pact, Actavis will grant Zydus an exclusive license to market its generic Asacol HD (mesalamine) starting on Nov. 15, 2015, or earlier under certain circumstances, after Zydus' receipt of final approval from the Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for generic Asacol HD.
If Zydus does not gain FDA approval of its generic Asacol HD by July 1, 2016, Actavis said, Zydus will be permitted to launch an authorized generic version of Actavis' product beginning on July 1, 2016.
Other terms of the settlement were not disclosed.
Asacol HD tablets are indicated for the treatment of moderately active ulcerative colitis in adults.