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, and Par’s ANDAs for dexmethylphenidate hydrochloride extended-release capsules for the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. Par has launched the 15 and 30 mg 30 strengths in late 2013. Par launched the 25 and 35 mg strengths in January 2017. As the first filer of an ANDA for generic Focalin XR® in the 25 and 35 mg Page 5 strengths, Par has 180 days of U.S. generic marketing exclusivity for these strengths. We believe Par is preparing to launch all the remaining strengths in the first half of 2017. Under a license and commercialization agreement between the Company and Par (as amended, the “Par agreement”), the Company receives quarterly profit-share payments on Par's U.S. sales of generic Focalin XR®.
Dexmethylphenidate hydrochloride, a Schedule II restricted product in the United States, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). According to Symphony Health Solutions, sales for the 12 months ended December 2016 of Focalin XR® in the U.S. were approximately $782 million (TRx MBS Dollars).
In 2005, we entered into a license and commercialization arrangement with 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 included the 30 and 40 mg strengths.