Intellipharmaceutics & Par Pharmaceutical Expand Development & Commercialization Agreement


Intellipharmaceutics International Inc. recently announced that they have added the development and commercialization of additional strengths of generic Focalin XR (dexmethylphenidate hydrochloride) for the US market to their existing agreement with Par Pharmaceuticals, which applied to the development and commercialization of the 5-, 10-, 15-, and 20-mg 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 $536 million for the 12 months ending June 2011. Five strengths (5, 10, 15, 20, and 30-mg) of a generic version of Focalin XR are currently the subject of Intellipharmaceutics’ pending 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 20-mg products, the terms of which are confidential. Intellipharmaceutics and Par are currently defendants in on-going US litigation against the same plaintiffs in regard to 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.”

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development, and manufacture of novel or generic controlled-release and targeted-release oral solid dosage drugs. The company’s patented Hypermatrix technology is a unique and validated multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals.