Generic Focalin XR®

Generic Focalin XR®

Our lead generic product candidate dexmethylphenidate hydrochloride extended-release capsules is a generic version of the marketed drug Focalin XR®, which is partnered with Par Pharmaceutical, Inc.

  • The U.S. Food and Drug Administration {"FDA") has granted final approval of the Company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. Commercial sale of these strengths will be launched immediately by the Company's commercialization partner in the United States Par Pharmaceutical, Inc. ("Par").
  • As the first-filer for the drug product in the 15 mg strength, the Company will have 180 days of exclusivity of generic sales from the date of launch in the United States by its partner, Par .
  • The Company's 5, 10, 20 and 40 mg strengths were also tentatively FDA approved, subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch by such parties. Par intends to launch these strengths immediately upon the expiry of those exclusivity periods.

Dexmethylphenidate hydrochloride, a Schedule II restricted product in the United States, is indicated for the treatment of attention deficit hyperactivity disorder (“ADHD”). According to Source Healthcare Analytics, sales for the 12 months ended October 2013 of Focalin XR® in the U.S. were approximately $683 million (TRx MBS Dollars).

In 2005, we entered into a license and commercialization arrangement with Par Pharmaceutical, Inc. (“Par”) for the development of a generic version of Focalin XR®.  . On August 18, 2011, we announced that we had added the development and commercialization of additional strengths of generic Focalin XR® to the existing license and commercialization arrangement with Par for the U.S. market. This includes the 30 and 40 mg strengths.