BioCentury
ARTICLE | Company News

Actavis, Shire sales and marketing update

May 6, 2013 7:00 AM UTC

Shire granted Actavis a license to market a generic version of Shire's ADHD drug Intuniv guanfacine in the U.S. beginning on Dec. 1, 2014. Actavis will have exclusive rights to market generic Intuniv for 180 days, during which Shire will receive 25% royalties of gross profits. Additionally, Shire granted Watson Pharmaceuticals Inc., which changed its name to Actavis in January, rights to market Watson's generic version of Intuniv in the U.S. 181 days after Actavis' launch. FDA has only approved Actavis' ANDA for generic Intuniv.

The deals settle litigation filed by Shire in 2010 in the U.S. District Court for the District of Delaware. The suits alleged that the generic companies' ANDA submissions for generic Intuniv infringed Shire's U.S. Patent Nos. 6,287,599 and 6,811,794. The patents cover sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles and expire on Dec. 20, 2020, and July 4, 2022, respectively. ...