DUBLIN, Ireland — Actavis plc has released guanfacine hydrochloride tablets as part of a settlement agreement with Shire plc.
Actavis said Monday that its product is a generic version of Shire’s Intuniv tablets, a medication for attention deficit hyperactivity disorder (ADHD).
Shipment of the generic product has commenced and, under Hatch-Waxman rules, it’s entitled to 180 days of marketing exclusivity, according to Actavis.
Intuniv is to treat ADHD in patients ages 6 to 17. For the 12 months ended June 30, the product had U.S. sales of approximately $668 million, according to IMS Health figures reported by Actavis.
