Oxazepam

Anxiety disorders have become one of the most prevalent mental disorders globally, and short- and medium-acting benzodiazepines with both efficacy and safety in clinical diagnosis and treatment are always in rigid demand. Oxazepam is a short-acting benzodiazepine sedative-hypnotic. It exerts anti-anxiety, sedative-hypnotic, anti-convulsant and skeletal muscle relaxant effects by acting on the γ-aminobutyric acid receptors of the central nervous system and enhancing the conduction effect of inhibitory neurotransmitters. Compared with other drugs of the same category, its metabolic process does not need to go through the hepatic oxidation stage, and it is eliminated only through glucuronidation conjugation, so it has higher medication safety for patients with hepatic insufficiency. It is mainly used for the short-term relief of anxiety, tension and agitation, and can also be used for the adjuvant treatment of mental depression symptoms accompanied by anxiety. Meanwhile, it is a commonly used intervention drug for alcohol withdrawal syndrome, and elderly patients and people with mild to moderate hepatic impairment can use it after evaluation.

The global oxazepam market size has maintained a steady growth trend in recent years. The overall market size was approximately USD 1.87 billion in 2023, and it is expected to reach USD 2.43 billion in 2028, with a compound annual growth rate of approximately 5.4%. In terms of the domestic market, this variety is included in the National Medical Insurance Category B Catalogue. The sales volume in sample hospitals was approximately RMB 120 million in 2022, and the terminal demand growth rate of primary medical institutions has remained above 8% for years. The competition pattern is dominated by generic drugs. At present, more than 10 domestic enterprises have obtained preparation approvals, and domestic manufacturers account for more than 90% of the API supply side. The overall price system is relatively stable, and no significant fluctuations have occurred.

The original research enterprise of oxazepam is Valeant Pharmaceuticals International, Inc. of Canada, and the original research brand name is Serax. The core compound patent expired globally in 1977. At present, the main dosage form of the original research marketed product is tablet, and the conventional specifications include 15mg and 30mg. The original research preparation has been included in the FDA Orange Book Reference Listed Drug Catalogue, but has not been included in the China Listed Drug Catalogue. In terms of domestic API registration, as of now, there are a total of 6 API registration numbers, of which 3 are in status A (already used in marketed preparations). A total of 7 domestic enterprises have obtained the approval of the National Medical Products Administration for the marketing of oxazepam tablets. (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 oxazepam API. All products of the full series meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities can be supplied from stock. In-stock products ordered before 16:00 can be dispatched on the same day, which can fully meet the R&D and production needs of pharmaceutical enterprises related to impurity research, quality control and generic drug consistency evaluation.