Actavis, Inc., the world's third-largest generics prescription drug manufacturer, has reached a settlement agreement with Shire plc resolving outstanding patent litigation related to Actavis' generic version of Intuniv (guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The settlement also resolves outstanding litigation against legacy Watson's Abbreviated New Drug Application (ANDA), which remains pending at the United States Food and Drug Administration (FDA).
On October 5, 2012, the FDA granted final approval of Actavis' ANDA for a generic version of Intuniv and awarded Actavis 180 days of ANDA market exclusivity. Under the terms of the agreement, Actavis can launch its generic version of Intuniv on December 1, 2014, or earlier under certain circumstances. Shire will receive a 25 per cent royalty on Actavis' gross profits from sales during the period of Actavis' exclusivity. Other details of the settlement were not disclosed.
"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," said Paul Bisaro, president and CEO of Actavis, Inc.
Intuniv had US sales of approximately $475 million for the 12 month period ending January 31, 2013 according to IMS Health.
Actavis, Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.