Actavis to launch generic ADHD drug in December 2014
PARSAPPANY, N.J. — Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.
The drug makers said they settled a patent-litigation suit concerning the drug Intuniv (guanfacine hydrochloride), allowing Actavis to launch in December 2014 and also settling outstanding litigation against a regulatory filing by Actavis predecessor Watson for Food and Drug Administration approval of a generic version of the drug. The FDA approved Actavis' version of the drug in October 2012 and, as the first company to file a complete application with the agency, Actavis is entitled to 180 days of market exclusivity in which to compete directly with the branded version after launching it.
Under the deal with Shire, Shire will receive a 25% royalty on Actavis' gross profits from the drug.
Intuniv had sales of about $475 million during the 12-month period that ended in January, according to IMS Health.