Olanzapine

The long-term management of severe mental disorders such as schizophrenia has always been one of the core topics in the global public health field. As a representative variety of the second-generation atypical antipsychotic drugs, olanzapine exerts its effect by antagonizing central dopamine D2 receptors and 5-hydroxytryptamine 2A receptors. Compared with traditional antipsychotic drugs, it has a lower incidence of extrapyramidal adverse reactions. It can not only effectively control the positive symptoms of schizophrenia (such as hallucinations and delusions), but also has a definite improvement effect on negative symptoms (such as apathy and social withdrawal) and symptoms related to affective disorders. It is a first-line drug for the acute phase treatment of adult schizophrenia and the prevention of recurrence in the maintenance phase, and can also be used for the treatment of moderate to severe manic episodes and the prevention of recurrence of bipolar affective disorder.

At present, the global olanzapine market size is stable at around US$7 billion, and the annual sales in the Chinese market exceed RMB 4 billion. In recent years, with the improvement of the diagnosis and treatment rate of mental disorders, the overall annual growth rate remains 3%-5%. In terms of the competitive landscape, the original research product still accounts for about 30% of the market share, and domestic generic drug enterprises have become the main force in the market by virtue of their cost advantages. More than 20 enterprises have had their olanzapine preparations pass the consistency evaluation of generic drugs, and this variety has been included in multiple batches of national centralized drug procurement. The price of preparations has dropped by more than 90% after centralized procurement, which further drives the continuous expansion of the demand for upstream API. Domestic API manufacturers are mainly concentrated in Jiangsu, Zhejiang and other regions.

The original research enterprise of olanzapine is Eli Lilly and Company in the United States, and the original research trade name is "Zyprexa". Its core compound patent expired in the US market in 2011, and the Chinese compound patent expired in 2017. The main dosage forms approved for the original research product include oral tablets (2.5mg, 5mg, 10mg, 15mg, 20mg) and orally disintegrating tablets, which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA reference preparation catalogue. On the domestic side, more than 30 enterprises have had their olanzapine APIs obtain A status through CDE registration, which can be legally supplied for the production of associated preparations, and a number of domestic olanzapine tablets and orally disintegrating tablet preparations have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity standard substances for olanzapine API, covering all categories such as synthetic process impurities and degradation impurities. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can meet the use needs of the whole process including API R&D, quality research, and consistency evaluation.