Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced that the company and Par Pharmaceutical, Inc. have added the development and commercialization of additional strengths of generic Focalin XR (dexmethylphenidate hydrochloride) for the US. market to their existing agreement, which applied to the development and commercialization of the 5, 10, 15 and 20mg strengths of generic Focalin XR.

Under the terms of the expanded agreement, Intellipharmaceutics will receive an immediate cash payment from Par and will continue to receive a share of profits from future sales. According to Wolters Kluwer Health, US sales of Focalin XR, used in the treatment of Attention Deficit Hyperactivity Disorder, were approximately US$536 million for the 12 months ending June 2011.

Five strengths (5, 10, 15, 20 and 30mg) of a generic version of Focalin XR are currently the subject of Intellipharmaceutics' pending Abbreviated New Drug Application (ANDA) with the FDA. Intellipharmaceutics and Par are parties to a settlement of their earlier US litigation against Novartis Pharmaceuticals Corporation, Elan Pharma International Ltd., and Celgene Corp. with respect to the 5, 10, 15, and 20mg products, the terms of which are confidential. Intellipharmaceutics and Par are currently defendants in on-going US litigation against the same plaintiffs as regards the 30 mg product.   

“We are extremely pleased with the expansion of the agreement we currently have in place with Par for the development and commercialization of generic Focalin XR,” commented Dr Isa Odidi, CEO of Intellipharmaceutics. “Today's announcement adds further credibility to the quality of our work and the growth of our Company.”