Maprotiline

In response to the clinical pain points of tricyclic antidepressants for depressive disorders, which have obvious anticholinergic side effects and insufficient tolerability, maprotiline, a tetracyclic antidepressant, exerts its effect by selectively inhibiting the reuptake of central norepinephrine, with extremely weak effect on 5-hydroxytryptamine reuptake. Compared with traditional tricyclic drugs, it has lower incidence rates of anticholinergic, sedative and cardiovascular adverse reactions. It is not only applicable to various types of depressive disorders, including endogenous depression, reactive depression, menopausal depression, etc., but also can be used for depressive patients with anxiety symptoms, and its suitability for the elderly depression group is particularly prominent.

Against the background of the continuous expansion of the global antidepressant market, maprotiline, as a classic and mature variety, currently has a global market size of approximately USD 120 million, and a domestic market size of approximately RMB 32 million, with a stable growth rate of around 3% in recent years. The competitive landscape is dominated by generic drugs. Nearly 10 domestic enterprises have obtained approval for preparations, the localization rate of APIs exceeds 90%, and it has not been included in the national centralized volume-based procurement scope, and the demand in primary medical care and chronic disease management scenarios is released steadily.

The original research enterprise of maprotiline is Novartis, and the original research brand name is Ludiomil. Its core compound patent expired globally in 1985. At present, the main dosage form of the original research approved globally is tablet, with three specifications including 25mg, 50mg and 75mg. The original research tablet has been included in the Catalogue of Marketed Drugs in China, and is the reference preparation for domestic generic drugs. Up to now, there are 6 maprotiline API registration information in the API registration platform of the Center for Drug Evaluation of China, among which 3 have been approved for marketing and can be sold and used domestically, and the maprotiline tablets of several domestic enterprises have been approved for marketing. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for maprotiline API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as API R&D, quality research and generic drug consistency evaluation.