Cariprazine

For central nervous system diseases such as schizophrenia and bipolar disorder, which are characterized by high recurrence rate and heavy disease burden, atypical antipsychotics with partial agonist activity on dopamine D3/D2 receptors have provided better therapeutic options for clinical practice. Cariprazine has an 8-fold higher affinity for D3 receptors than for D2 receptors, and can simultaneously regulate the levels of multiple neurotransmitters such as dopamine and 5-hydroxytryptamine. It can not only effectively control the positive and negative symptoms of schizophrenia, but also improve manic and depressive episodes of bipolar I disorder, and is less likely to cause adverse reactions such as elevated prolactin and weight gain, making it particularly suitable for adult patients requiring long-term maintenance treatment.

The global cariprazine market size had exceeded US$3.2 billion in 2023, with a compound annual growth rate of 28.7% in the past five years. The growth is mainly driven by the increased clinical penetration rate of its bipolar depression indication. In the current market landscape, the originator product still holds a dominant position. As the core patents expire successively, generic drug manufacturers have started to lay out relevant pipelines. The domestic market is currently in the stage of exclusive possession by the originator product, with no generic drugs approved, and the potential clinical demand has not been fully released.

The originator of cariprazine was jointly developed by Gedeon Richter and AbbVie. The originator product has the trade name Vraylar, its compound patent in the United States expires in 2029, and the core compound patent in China expires in 2031. The currently approved main dosage form is oral capsules, with specifications including 1.5mg, 3mg, 4.5mg and 6mg. The originator capsules have been included in the NMPA Reference Listed Drug Catalog of Chemical Drugs. As of now, no domestic enterprise has obtained the CDE registration number for cariprazine active pharmaceutical ingredient, and only the originator imported preparation was approved for marketing in China in 2023. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of cariprazine impurity reference standards, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the process of API R&D, quality research and generic drug declaration.