Par Pharmaceutical Begins Shipment of Generic Focalin XR® Capsules Company Launches with 180 Days Marketing Exclusivity for 15 mg Strength
WOODCLIFF LAKE, N.J., Nov. 20, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has begun shipping dexmethylphenidate hydrochloride (HCl) 15 mg and 30 mg extended-release (ER) capsules CII following approval by the U.S. Food and Drug Administration. As marketer and distributor, Par will have 180 days of marketing exclusivity for the 15 mg strength and will share profits with its development partner.
Dexmethylphenidate HCl ER is the generic version of Novartis' Focalin XR® and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. According to IMS Health data, annual U.S. sales of the Focalin XR® 15 mg and 30 mg strengths are approximately $202 million.
Important Information About Dexmethylphenidate HCl ER Capsules
Dexmethylphenidate HCl extended-release capsules should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior. Refer to full prescribing information for complete boxed warning.
Dexmethylphenidate HCl extended-release capsules are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms; patients known to be hypersensitive to methylphenidate or other components of the product; patients with glaucoma; patients with motor tics or with a family history or diagnosis of Tourette's syndrome; and during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies