Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
In a Wall Street Journal article, Timothy W. Martin writes that "OxyContin is set to go off patent next year, but the maker of the powerful and heavily abused prescription painkiller is trying to extend its exclusive rights to the drug, arguing that a new version it spent $100 million to develop might substantially curtail abuse. Whether Purdue Pharma LP will be able to protect its reformulated OxyContin will be decided by the courts."
Purdue Pharma LP argues that its new version of OxyContin, which has patent protection until 2025, is more abuse-resistent than the original formulation, and "generic-drug makers should be prevented from producing the original version of OxyContin." Manufacturers of generic drugs, on the other hand, "say Purdue Pharma is just trying to protect a lucrative market for itself, and that they can make their own abuse-deterrent formulations of the drug." Read the full article here.
Commenting on the article, Intellipharmaceutics CEO Dr. Isa Odidi stated,
"We expect that any 'generic' of OxyContin will have to have an abuse deterrent technology; this would result in a NDA or NDA 505(b)(2) regulatory path. A pure generic to the original version of OxyContin will not be available; this would be the ANDA regulatory path. The new version of OxyContin from Purdue has additional patent protection to 2025, therefore a generic to this version will be challenging as they have to claim that the change will not merit extending Purdue's patent protection.
Our lead non-generic product under development is Rexista(tm) oxycodone hydrochloride, intended as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. Rexista(tm) is a unique dosage form designed to be a deterrent to some of the well-documented abuses associated with some currently marketed controlled-release oxycodone products. This includes abuse of these drugs by nasal inhalation when crushed or powdered, or by injection when combined with solvents. Rexista(tm) oxycodone is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs."