Intellipharmaceutics International is facing legal action related to a patent infringement case from Purdue Pharma.
Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc. (collectively, “Purdue”), Rhodes Technologies, and Grünenthal GmbH (collectively, “plaintiffs”) have commenced patent infringement proceedings against the Company in the United States District Court for the District of Delaware in respect of the Company’s New Drug Application (“NDA”) filing for its Rexista™ product candidate (abuse-deterrent oxycodone hydrochloride extended release tablets) with the United States Food and Drug administration (“FDA”).
Intellipharmaceutics had previously filed its NDA for its RexistaTM product candidate on November 24, 2016, relying on the 505(b)(2) regulatory pathway, which allowed us to reference data from Purdue’s OxyContin® extended release oxycodone hydrochloride then in the market in the U.S. The RexistaTM application was accepted by the FDA for further review on February 1, 2017. The Company then certified to the FDA that it believed that its RexistaTM product would not infringe any of the sixteen (16) patents owned by one or more of the plaintiffs, or that such patents are invalid, and it so notified the plaintiffs of such certification. On April 7, 2017, the plaintiffs filed the above-noted legal proceedings, alleging that RexistaTM infringes six (6) out of the sixteen (16) patents.
By reason of the commencement of these legal proceedings, the FDA is stayed for 30 months from granting final approval to the Company’s RexistaTM abuse-deterrent oxycodone. That time period commenced on February 24, 2017, when the plaintiffs were notified of the Company certification concerning the patents, and will expire on August 24, 2019, unless the stay is earlier terminated by a final declaration of the courts that the patents are invalid, or are not infringed, or the matter is otherwise settled among the parties.
Dr. Isa Odidi, CEO and Co-Chief Scientist of the Company, stated, “Contesting litigation of this nature is part of what it takes to compete for the right to market valuable novel drug products in the United States. We have engaged highly regarded patent counsel with substantial directly applicable experience. We believe that we do not infringe the subject patents and that we have a well-prepared strategy to vigorously defend the Company against these claims.”
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 Abbreviated New Drug Application (“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 NDA 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista™, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ (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.