PARSIPPANY, N.J., April 25, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT), a leading specialty pharmaceutical company, today announced that is 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. 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 percent 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 U.S. sales of approximately $475 million for the 12 month period ending January 31, 2013 according to IMS Health.About Actavis, Inc.Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland. Actavis is the world's third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets. Actavis Pharma also develops and out-licenses generic pharmaceutical products outside the U.S. through its Medis third-party business, a world leading generic pharmaceutical out-licensing business. Medis has more than 300 customers globally, and offers a broad portfolio of more than 200 products.