Dothiepin

In the clinical medication spectrum for mental disorders, tricyclic antidepressants are an important option for the treatment of refractory depression. As a representative variety of this class of drugs, dosulepin exerts dual antidepressant and anxiolytic effects by simultaneously inhibiting the reuptake of serotonin and norepinephrine and upregulating the concentrations of these two neurotransmitters in the synaptic cleft. Its indications cover moderate to severe depressive episodes, and it is particularly suitable for depressed patients with concomitant anxiety symptoms and sleep disorders. Elderly depressed people who have good tolerance to tricyclic drugs can also use it after dose adjustment. It can also be used clinically to assist in alleviating emotional abnormalities associated with chronic neuralgia.

The current global market size of dosulepin is approximately USD 230 million, with a compound annual growth rate of around 2.7% in the past three years, and the market demand is relatively stable. The competitive landscape is characterized by domination by original research manufacturers and supplementation by generic drug enterprises. Europe and Southeast Asia are the core consumption regions. The domestic market is still in the introduction stage, and dosulepin has not been included in the scope of national centralized procurement varieties. The number of enterprises applying for relevant generic drugs is small, and the clinical accessibility still has room for improvement.

The original research enterprise of dosulepin is Servier, and the original brand name is Prothiaden. Its core compound patent expired in the EU region in 2003, and the core patent in the US market also expired in 2004. At present, all major global markets have opened the application for generic drugs. The main dosage form of the original research marketed product is tablet, with core specifications including 25mg and 75mg, which have been included in the FDA Reference Listed Drug Catalog, but have not yet been included in the *List of Chemical Drugs* in China. No valid and active API registration number of dosulepin has been found on the domestic API registration platform for the time being. The number of approved and marketed preparation varieties is extremely small, and clinical medication mainly relies on a small number of import channels for supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for impurity reference standards in the generic drug development and quality research of dosulepin, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can meet the needs of various R&D scenarios such as impurity qualitative research, quantitative research and stability investigation in a one-stop manner.