Actavis finalises agreement to settle patent issue with Zydus USA

Irish pharma major Actavis plc has informed that it has finalised agreement with Zydus Pharmaceuticals USA Inc to settle all outstanding patent litigation related to Zydus’ generic version of Asacol (mesalamine) delayed-release tablets.

According to the agreement, Actavis will grant Zydus an exclusive license to market its generic Asacol beginning on November 15, 2015, or earlier under certain circumstances, following approval from the US Food and Drug Administration (USFDA) on Zydus’ abbreviated new drug application (ANDA) for generic Asacol. The drug is used to treat ulcerative colitis.

Alternatively, if Zydus does not gain FDA approval of its generic Asacol HD by July 1, 2016, Zydus will be permitted to launch an authorised generic version of Actavis’ product beginning on July 1, 2016.  Other terms of the agreement were not disclosed.

Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.  Actavis has global headquarters in Dublin, Ireland and its  US administrative headquarters in Parsippany, New Jersey, USA.

It develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products.

Earlier, this year, Ahmedabad-based pharma major Cadila Healthcare Limited (Zydus Cadila) and its subsidiary Zydus Pharmaceuticals (USA) Inc had  entered into an agreement with Depomed, Inc. to settle their ongoing patent infringement litigation related to neuropathic pain drug Gralise (gabapentin) 300 mg and 600 mg tablets.