Intellipharmaceutics’ (NASDAQ: IPCI) is uniquely positioned to operate in the niche market created by the expiration of drug product patents and exclusivity periods. Part of the company’s strategy includes formulating generic products that are bioequivalent to products covered by soon-to-expire or already expired patents. Intellipharmaceutics recently announced that its marketing partner, Par Pharmaceutical (“Par”), has launched its generic Focalin XR® capsules in 25 and 35 mg strengths in the United States. The FDA has approved Par’s abbreviated new drug application (“ANDA”) for its generic Focalin XR capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. As the first filer of an ANDA for generic Focalin XR® in the 25 and 35 mg strengths in particular, Par has 180 days of U.S. generic marketing exclusivity for those strengths. Under a commercialization and licensing agreement with Par, Intellipharmaceutics will receive profit-share payments of U.S. sales of generic Focalin XR – which Intellipharmaceutics CEO Isa Odidi in a press release said should “significantly” improve the company’s revenues in 2017. Focalin XR® is currently marketed by Novartis (NYSE: NVS) for the treatment of attention deficit hyperactivity disorder. As reported in the press release, Symphony Health Solutions reported that sales for the 12 months ended November 2016 of Focalin XR® in the 25 and 35 mg strengths combined were approximately $80 million.
To learn more, visit: www.intellipharmaceutics.com
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including ANDAs filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain. Intellipharmaceutics also has New Drug Application (“NDA”) 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista® (abuse deterrent oxycodone hydrochloride extended release tablets), based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista® and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency’s findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.
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