Quetiapine

In the field of global schizophrenia diagnosis and treatment, atypical antipsychotics are currently the first-line medication options. Quetiapine, as a representative variety among them, exerts its effect by antagonizing central dopamine D2 receptors and 5-hydroxytryptamine 2A receptors. Compared with traditional antipsychotics, it has a lower incidence of extrapyramidal adverse reactions. It can not only comprehensively improve the positive symptoms, negative symptoms and cognitive function impairment of schizophrenia, but also is approved for the treatment of manic episodes and depressive episodes of bipolar disorder. It is one of the core medications for the treatment of adult mental disorders, and is also recommended by multiple guidelines for individualized psychiatric symptom intervention in special populations.

At present, the global market size of quetiapine has exceeded 1.3 billion US dollars, and the annual sales in the Chinese market exceed 3 billion yuan, with a compound growth rate of around 6% in the past five years. After the patent cliff, the generic drug market has expanded rapidly. There are 27 domestic quetiapine preparation manufacturers that have obtained approval, among which 19 products have passed the consistency evaluation. The winning bid price in centralized procurement at public medical institutions has dropped by more than 70% compared with the price of the original research drug, and the market share of the winning enterprises continues to rise. The demand for upstream API maintains steady growth along with the increase of generic drug penetration rate, and there is no obvious supply gap for the time being.

The original research enterprise of quetiapine is AstraZeneca, with the trade name "Seroquel". Its core compound patent in the United States expired in 2011, and the compound patent in China expired in 2003. The patents for sustained-release dosage forms expired in the United States and China in 2016 and 2017 respectively. The main dosage forms approved for the original research drug include conventional tablets (25mg, 100mg, 200mg, 300mg) and sustained-release tablets (50mg, 200mg, 300mg, 400mg). Relevant dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also included in the FDA Reference Preparation Catalogue. Up to now, there are 22 quetiapine API registration records in the API Registration Platform of China Center for Drug Evaluation (CDE), among which 15 have been publicized in status A, and all domestic generic preparations have achieved commercial launch and supply. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for quetiapine API, which can fully meet the needs of generic drug consistency evaluation, quality research and routine release testing. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can help relevant enterprises efficiently complete quality control in the whole process of R&D and production.