Lurasidone

The global prevalence of mental disorders continues to rise. Among them, schizophrenia, as a severe mental illness with high recurrence and high disability, has long been plagued by treatment pain points of frequent adverse reactions and poor compliance in clinical practice. Lurasidone is a second-generation atypical antipsychotic drug, which exerts its effect by high-affinity antagonism of dopamine D2 receptor, 5-hydroxytryptamine 2A receptor and 5-hydroxytryptamine 1A receptor. Compared with traditional antipsychotic drugs, it has a lower incidence of extrapyramidal reactions and less impact on body weight and glucose and lipid metabolism. It is not only suitable for acute phase control and maintenance phase recurrence prevention of schizophrenia in adults, but also can be used for adolescent patients with schizophrenia aged 13-17, as well as monotherapy or adjuvant therapy for depressive episodes of bipolar disorder in adults.

The global market size of lurasidone has maintained steady growth in recent years, exceeding USD 3.2 billion in 2023. The growth rate of the Chinese market is significantly higher than the global average, with a compound annual growth rate of 41% from 2019 to 2023. As the patent of the original drug expires, domestic generic drug companies have accelerated their layout. At present, lurasidone preparations from 12 companies have been approved for marketing, and this variety has been included in the seventh batch of nationally organized drug centralized procurement. The maximum price reduction of the selected products is more than 90% compared with the original drug, which has greatly improved clinical accessibility, and also driven the continuous expansion of upstream API demand. There is no publicly available specific statistical data on the domestic lurasidone API market size at present.

The original developer of lurasidone is Sumitomo Pharma of Japan, with the original brand name "Latuda". Its US compound patent expired in 2019, and its core compound patent in China expired in 2023. The main dosage form approved for the original drug is tablet, with specifications including 20mg, 40mg, 60mg, 80mg and 120mg. Among them, the original tablet has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of the NMPA, and is also a reference preparation recognized by the FDA. As of June 2025, there are 11 lurasidone API registration entries on the CDE API Registration Platform, among which 6 have been activated with A status and can be used for domestic preparation production; 14 domestic lurasidone preparation varieties have obtained marketing approval. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of lurasidone impurity reference standards, covering all research scenarios such as process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support relevant work such as API quality research and generic drug consistency evaluation.