Protriptyline

For mental disorders such as depression with a high recurrence rate, clinical treatment often needs to take both onset speed and long-term compliance into account, and tricyclic antidepressants are still an important option for moderate to severe depression up to now. Protriptyline is a secondary amine compound among tricyclic antidepressants. It increases the concentrations of 5-hydroxytryptamine and norepinephrine in the synaptic cleft by inhibiting the reuptake of these two neurotransmitters by the central nervous system, so as to improve depressive mood. Meanwhile, it has a certain sedative effect, and is especially suitable for adult depressive patients with anxiety symptoms and sleep disorders. It can also be used as a combined medication option for some refractory depression cases.

At present, the global tricyclic antidepressant market maintains steady growth. As a细分 variety with high clinical recognition among such drugs, protriptyline had a global market size of approximately USD 120 million in 2023, with a compound annual growth rate of around 3.2%. Due to the early expiration of its patent, the current market is dominated by generic drug supplies, with the United States and India being the main API production regions. In China, the clinical application of this variety is still dominated by imported preparations at present, and generic drug declaration is still in the early stage. The supply gap of API is relatively obvious, and there is no publicly verifiable segmented market size data available for now.

The original research enterprise of protriptyline is Merck Sharp & Dohme, with the original brand name Vivactil. Its core compound patent expired globally in 1983. The main dosage form approved for the original drug is tablet, with specifications of 5mg and 10mg, which has been included in the FDA Reference Listed Drug Catalog. Currently, no protriptyline preparation has been approved for marketing in China, and there is no valid protriptyline DMF registration number in A status or I status in the API registration database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. (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 protriptyline, which fully meets the impurity reference standard requirements for the whole process of API R&D, quality research, generic drug declaration, etc. Most products are in regular stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be provided with complete structure confirmation and calibration reports simultaneously, helping customers shorten the R&D cycle and reduce compliance risks.