Actavis plc announced that it has launched a generic version of Intuniv, as part of a settlement agreement with Shire plc.
(NYSE: ACT) announced that it has launched a generic version of Intuniv
(guanfacine hydrochloride), as part of a settlement agreement with
has begun shipping the product and, under applicable Hatch Waxman rules, is entitled to 180 days of marketing exclusivity.
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
had U.S. sales of approximately
, according to
(NYSE:ACT), headquartered in
, 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 www.actavis.com.
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
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.