Actavis has resolved outstanding patent litigation concerning generic version of Intuniv (guanfacine hydrochloride), indicated for the treatment of attention deficit hyperactivity disorder, with Shire.
The settlement agreement also resolves outstanding litigation against legacy Watson's abbreviated new drug application that remains pending at FDA.
Actavis president and CEO Paul Bisaro said, "The launch of a generic version of Intuniv on December 1, 2014 ensures that consumers will benefit from an earlier launch of a guanfacine hydrochloride product."
The US regulator granted final approval of Actavis' ANDA for the generic Intuniv with 180 days of ANDA market exclusivity, on 5 October 2012.
As per the agreement, Actavis can launch the generic product on 1 December 2014, or earlier under certain circumstances.
During the period of Actavis' exclusivity, Shire will receive 25% royalty on sales based gross profits.
Additional details of the settlement agreement have not been disclosed.
