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