Dapoxetine

Premature ejaculation in men is a common ejaculatory dysfunction in clinical practice, with a prevalence of approximately 20%-30% among the global male population aged 18-64. Long-term lack of intervention will significantly affect the quality of life of patients and their partner relationships. Dapoxetine belongs to the class of selective serotonin reuptake inhibitor (SSRI) drugs. By inhibiting the reuptake process of the serotonin transporter on the presynaptic membrane, it increases the serotonin concentration in the synaptic cleft and prolongs the ejaculatory latency. It is currently the world's first and only oral therapeutic drug approved for the indication of premature ejaculation. It takes effect rapidly when taken on demand, with mild adverse reactions and good tolerance, and has become the first-choice clinical treatment regimen in this field.

The global market size related to dapoxetine exceeded 1.8 billion US dollars in 2023, with a compound annual growth rate of around 12% in the recent three years, among which emerging markets have particularly strong growth momentum. In terms of the domestic market, with the improvement of male health awareness and the standardization of premature ejaculation diagnosis and treatment pathways, the overall domestic dapoxetine market size exceeded 1.2 billion yuan in 2023. At present, nearly 30 generic drug manufacturers have obtained approvals. After winning the bid in the centralized procurement, the price per box has dropped to about 10% of that of the original research drug, and the product accessibility has been greatly improved. The mid- and low-end markets have been basically occupied by domestic generic drugs, while the original research products still dominate the high-end public medical market.

The original research manufacturer of dapoxetine is Johnson & Johnson of the United States, with the original brand name "Priligy". The core compound patent of the drug expired in 2021 in major markets such as Europe and the United States, and expired in China in 2022. The main dosage form of the original research drug that has been launched is tablet, with specifications of 30mg and 60mg. It 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 the retrieval time point, a total of 17 dapoxetine API manufacturers have obtained the A status as announced on the domestic API registration platform, the number of approved domestic preparations exceeds 40, and the original research preparation has also been approved and marketed in China for many years. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for dapoxetine API. The related products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and spot orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable supply support of impurity reference standards for the R&D, registration and mass production links of pharmaceutical enterprises.