Dalfampridine

In response to the clinical intervention needs for acute-phase symptoms such as positive symptoms of schizophrenia and agitated behavior, long-acting antipsychotics have become an important option for the current treatment of mental disorders due to their advantages of low administration frequency and high medication adherence. Droperidol is a long-acting butyrophenone antipsychotic, which exerts its effect by blocking central dopamine D2 receptors, and has moderate affinity for 5-HT2A receptors at the same time, which can reduce the risk of extrapyramidal reactions. Clinically, it is mainly used for the maintenance treatment of schizophrenia, and can also be used to control manic episodes and agitation symptoms of organic mental disorders. It is especially suitable for adult patients with poor adherence to oral medications and recurrent attacks, and can significantly reduce the risks of disease recurrence and rehospitalization.

At present, the global market size of long-acting antipsychotics has exceeded 7 billion US dollars, with a compound annual growth rate of more than 8%. Among them, long-acting butyrophenone preparations account for about 12% of the segmented market share by virtue of their high cost-effectiveness and mature clinical application. In terms of the domestic market, with the improvement of the diagnosis and treatment rate of mental disorders and the expansion of the coverage of medical insurance for long-acting preparations, the hospital terminal sales growth rate of droperidol-related preparations has remained stable at around 15% in the past 3 years. Currently, the domestic preparation market is dominated by imported products, and 3 local enterprises have submitted marketing applications for generic drugs. In the future, with the approval of generic drugs, the accessibility will be further improved.

The original research enterprise of droperidol is Janssen Pharmaceutica N.V., with the original brand name Inapsine, and its core compound patent in the US market expired in 1986. The dosage form approved for the original drug is injection, with specifications of 5mg/mL and 10mg/mL, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no enterprise has submitted the API registration number of droperidol on the CDE API registration platform. Only the original imported injection products have been approved in China, and no local generic drugs have been marketed yet. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for droperidol API. 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 Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in drug R&D, quality research and declaration work.