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news.Intellipharmaceutics International, its wholly owned subsidiary Intellipharmaceutics Corporation (collectively Intellipharmaceutics) and their licensee and development partner Par Pharmaceutical, (Par) have received confirmation that the previously announced stays of the patent litigation concerning, Focalin XR, have expired without regulatory intervention and that the parties have stipulated to a dismissal of the litigation.
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Intellipharmaceutics, Par, Novartis Pharmaceuticals, Novartis Pharma, Celgene, Elan and Elan Pharma, have also entered into license agreements in conjunction with the settlements of the litigation concerning the company’s generic drug application in the FDA for 5, 10, 15 and 20mg strengths of dexmethylphenidate hydrochloride.
Intellipharmaceutics and Par said that pursuant to the license agreements, they are granted fully paid up, royalty-free, non-exclusive licenses under the relevant patents pertaining to Focalin XR. These licenses are expected to permit Par to market, offer for sale, sell or take orders in the US starting in October 2012 for any of the Intellipharmaceutics’ 5, 10, 15, and 20mg strengths of dexmethylphenidate hydrochloride XR capsules that have received final FDA approval.
Intellipharmaceutics said that it has a 10 year profit-sharing agreement with Par for the sale of dexmethylphenidate hydrochloride XR capsules in the US, which commences with the commercial launch of the product by Par.
Isa Odidi, CEO and co-founder of Intellipharmaceutics, said: “We are extremely pleased about the filing of the stipulations of dismissal of the litigation involving our lead ANDA product, a generic version of the controlled-release drug Focalin XR.”