DUBLIN, Dec. 1, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has launched a generic version of Intuniv® (guanfacine hydrochloride), as part of a settlement agreement with Shire plc. Actavis has begun shipping the product and, under applicable Hatch Waxman rules, is entitled to 180 days of marketing exclusivity.
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Intuniv® 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 data.
About Actavis
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.
Actavis 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. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.
For more information, visit Actavis' website at www.actavis.com.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' 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 FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; the difficulty of predicting how the FDA will interpret applicable Hatch Waxman rules related to Actavis' entitlement to marketing exclusivity and the possibility that an adverse interpretation of such rules could negatively affect Actavis' marketing exclusivity; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis' 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, Actavis disclaims any intent or obligation to update these forward-looking statements.
Intuniv® is a registered trademark of Shire LLC.
| CONTACTS: |
Investors: |
| Lisa DeFrancesco |
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| (862) 261-7152 |
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| Media: |
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| Charlie Mayr |
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| (862) 261-8030 |
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| David Belian |
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| (862) 261-8141 |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/actavis-launches-generic-version-of-intuniv-300002813.html
SOURCE Actavis plc
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