Oxycodone

Opioid analgesics are the core medications for the management of moderate to severe pain. Among them, oxycodone, as a semi-synthetic opioid receptor agonist, exerts analgesic effects by specifically agonizing the μ and κ opioid receptors in the central nervous system. Its analgesic potency is approximately 1.5 to 2 times that of morphine, and its relief effect on visceral pain is superior to that of traditional opioids. Its clinical indications cover moderate to severe cancer pain, acute postoperative pain, chronic non-cancer pain, etc., and it is applicable to the patient population whose pain cannot be effectively controlled by other analgesic drugs. It is a recommended medication for the second and third steps of the WHO three-step analgesic ladder, and has dual application values: the immediate-release formulation is used for breakthrough pain control, and the sustained-release formulation is used for long-term analgesia.

The global oxycodone market size maintains steady growth, with a market size of approximately USD 3.8 billion in 2023 and a compound annual growth rate of approximately 3.2%. The growth drivers mainly come from the expansion of the global cancer pain patient base and the increase in the popularity of chronic pain diagnosis and treatment. Affected by the policy control of controlled drugs, the market concentration is relatively high, with originator enterprises occupying the main market share, and the approval threshold for generic drugs is much higher than that of ordinary chemical drugs. The Chinese market is constrained by the control policies for narcotic and psychotropic drugs. Currently, domestic sales are dominated by the originator drug and a small number of compliant generic drug enterprises. In 2023, the sales volume of oxycodone-related preparations in domestic sample hospitals was approximately RMB 1.2 billion, of which sustained-release formulations accounted for more than 70%.

The originator enterprise of oxycodone is Purdue Pharma, and the originator brand name is OxyContin. Its core compound patent expired in 1996, and most of the subsequent improvement patents for sustained-release formulations also expired around 2020. The main formulations of the originator drug include oxycodone hydrochloride sustained-release tablets (specifications of 5mg, 10mg, 20mg, 40mg, etc.) and oxycodone hydrochloride injection. The relevant formulations have been included in the FDA Reference Listed Drug Catalog, and the originator sustained-release tablets and injection have also been included in the *Catalog of Reference Listed Drugs for Chemical Drugs* in China. Up to now, there is no oxycodone API registration number approved by domestic enterprises on the API registration platform of China CDE, and only the relevant preparations of the originator and a small number of imported manufacturers have been approved for marketing by China NMPA. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for oxycodone API. The products strictly comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock, and stock orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for the whole process of drug R&D, quality research and production.