Generic OxyContin Becomes Available Over Protests by Provinces and First Nations Communities

On November 25, 2012, the patent for the brand name pain killer OxyContin expired, opening the way for generic versions of the drug to be made available on the Canadian market. OxyContin is a time-release tablet containing the opioid oxycodone hydrochloride (oxycodone), a drug prone to misuse and addiction. The time-release formulation continuously releases the drug over a period of time, and therefore prolongs the analgesic effect. As a result, OxyContin contains a greater amount of the drug than “immediate” release forms of oxycodone, which were already available in generic versions. However, it was discovered that this higher amount of oxycodone in OxyContin could be made to release immediately by crushing or tampering with the tablets, making it easy to abuse. Earlier this year, the brand-name manufacturer of OxyContin, Purdue Pharma, withdrew OxyContin from the Canadian market and introduced OxyNeo, which is said to be more difficult to tamper with. The provinces and First Nations communities had asked the federal Minister of Health (Minister), Leona Aglukkaq, to delay the introduction of generic OxyContin. The Minister has refused to interfere with the drug approval process, setting out her reasons for her refusal in a letter to the provinces and territories. The Minister explained that there “is no basis in the Food and Drugs Act for the Minister of Health to withhold approval of a drug where the drug is otherwise considered safe and effective for its recommended use.” For the reaction of Ontario’s Minister of Health, follow this link. Some critics have suggested that Purdue Pharma has changed its marketed product from OxyContin to OxyNeo to protect its profits. Because of patents covering OxyNeo, generic versions of this formulation of the drug would not be available until 2027, unless the patents are successfully challenged in court. In addition, according to the Minister, although OxyNeo has been described as “tamper-proof”, "tamper-resistant" or "harder to abuse", Health Canada has determined that there was “insufficient proof” to support these claims; and Purdue Pharma is not authorized to make such claims in marketing the product. For additional articles discussing this issue, follow the links here, here, here and here. Summary by: Cheryl Cheung