Risperidone

Schizophrenia is a severe mental disorder with a prolonged course and high recurrence rate, and there has long been an urgent clinical demand for drugs with both efficacy and safety for its long-term treatment. Risperidone is a second-generation atypical antipsychotic drug that exerts its effect by blocking central 5-hydroxytryptamine 2A receptors and dopamine D2 receptors with high affinity. It can not only improve the positive symptoms of schizophrenia (hallucinations, delusions, thought disorder), but also relieve negative symptoms (affective flattening, social withdrawal), and meanwhile reduce the risk of extrapyramidal adverse reactions that are easily induced by traditional antipsychotics. It is a first-line drug for the acute phase and maintenance treatment of schizophrenia in adults, and can also be used for the short-term treatment of manic episodes of bipolar disorder.

At present, the global risperidone market size is stably around USD 1.8 billion, and the annual sales in the Chinese market exceed RMB 3 billion. With the increase in the consultation rate of mental disorders and the improvement of long-term treatment compliance, the compound growth rate in the past three years has remained at 4.2%. As the core patents have long expired, the market presents a pattern where the original drug and generic drugs coexist. The number of approved domestic generic drugs has exceeded 30, among which oral immediate-release dosage forms have been included in multiple rounds of national centralized procurement, with the highest price cut of the winning bids exceeding 90% compared with the original drug. In terms of API supply, domestic enterprises have achieved independent mass production, which can fully meet the production needs of generic drug manufacturers.

The original developer of risperidone is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and the original drug's trade name is "Risperdal". Its core compound patent expired in the United States in 2003, and the Chinese compound patent expired in 2004. The main dosage forms of the original marketed drug include oral tablets in specifications of 1mg, 2mg and 3mg, oral solution in specification of 1mg/ml, and long-acting injection in specifications of 25mg/50mg. Among them, the oral immediate-release dosage form has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. As of now, there are 42 A-status registration numbers of risperidone API publicly announced on the platform of the Center for Drug Evaluation of China, and more than 30 domestic enterprises have obtained marketing approval for risperidone oral preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for risperidone API. Most of the products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and the structures of impurities have been fully confirmed by spectroscopy, which can meet the full-process needs of API registration and declaration, quality research and stability testing.