Actavis Launches Generic Version of Intuniv

December 1, 2014

Actavis plc announced that it has launched a generic version of Intuniv, as part of a settlement agreement with Shire plc.

Actavis plc

(NYSE: ACT) announced that it has launched a generic version of Intuniv


(guanfacine hydrochloride), as part of a settlement agreement with

Shire plc



has begun shipping the product and, under applicable Hatch Waxman rules, is entitled to 180 days of marketing exclusivity.

Logo -



is a prescription medicine used to treat Attention Deficit Hyperactivity Disorder in patients ages 6 to 17. For the 12-month period ending

June 30, 2014

, Intuniv


had U.S. sales of approximately

$668 million

, according to

IMS Health




Actavis plc

(NYSE:ACT), headquartered in

Dublin, Ireland

, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.


markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.


has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit


website at

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect


current perspective of existing information as of the date of this release. It is important to note that


goals and expectations are not predictions of actual performance. Actual results may differ materially from


current expectations depending upon a number of factors, risks and uncertainties affecting


business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with


and other governmental regulations applicable to


and its third party manufacturers' facilities, products and/or businesses; the difficulty of predicting how the


will interpret applicable Hatch Waxman rules related to


entitlement to marketing exclusivity and the possibility that an adverse interpretation of such rules could negatively affect


marketing exclusivity; changes in the laws and regulations, including




, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in


periodic public filings with the

Securities and Exchange Commission

, including but not limited to

Actavis plc's

quarterly report on Form 10-Q for the quarter ended

September 30, 2014

. Except as expressly required by law,


disclaims any intent or obligation to update these forward-looking statements.