Par Pharmaceutical Companies, Inc. has begun shipping dexmethylphenidate hydrochloride (HCl) 15 mg and 30 mg extended-release (ER) capsules CII following approval by the US 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 US sales of the Focalin XR 15 mg and 30 mg strengths are approximately $202 million.
Par Pharmaceutical Companies, Inc. is a privately held, US-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.