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.