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PARSIPPANY, N.J. — Actavis Inc. plans to launch a generic version of the ADHD drug Intuniv next year under a settlement with Shire.
Actavis said Thursday that the settlement for its Intuniv generic (guanfacine hydrochloride) resolves outstanding patent litigation with Shire as well as with legacy Watson’s Abbreviated New Drug Application (ANDA), which is pending at the Food and Drug Administration.
The FDA approved Actavis’ ANDA for an Intuniv generic on Oct. 5, 2012, and gave Actavis 180 days of ANDA market exclusivity, according to Actavis. Under the terms of the agreement, Actavis can release its generic version of Intuniv on Dec. 1, 2014, or earlier under certain circumstances.
Shire will receive a 25% royalty on Actavis’ gross profits from sales during the period of Actavis’ exclusivity. Other terms of the settlement weren’t disclosed.
"The launch of a generic version of Intuniv on Dec. 1, 2014, ensures that consumers will benefit from an earlier launch of a guanfacine hydrochloride product," stated Paul Bisaro, president and chief executive officer of Actavis.
Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17.
The medication had U.S. sales of about $475 million for the 12 months ended Jan. 31, according to IMS Health data cited by Actavis.
