Nortriptyline

In the long-term clinical management of depressive disorders, tricyclic antidepressants have always been the core choice for second-line treatment due to their definite efficacy. As the active metabolite of amitriptyline, nortriptyline is a representative variety with better tolerance among them. It exerts an antidepressant effect by selectively inhibiting norepinephrine reuptake, mildly inhibiting 5-hydroxytryptamine reuptake, and down-regulating β-adrenergic receptor function. It is suitable for various types of depression, and has particularly prominent safety for elderly depressed patients with symptoms of anxiety and insomnia. It can also be used clinically for the adjuvant treatment of neuropathic pain and childhood enuresis.

In the global antidepressant drug market, although tricyclic drugs do not account for a high proportion, there is still stable demand in primary medical care and less developed regions. The global annual market size of nortriptyline is approximately USD 120 million, with a compound annual growth rate of 2.1% in the past three years. The growth mainly comes from the expansion of off-label application in the field of pain. At present, the overseas market is dominated by generic drug supply, while there are no imported original research drugs or domestic generic drugs launched in the domestic market, which is in a state where clinical needs are unmet. In the future, with the improvement of domestic psychotropic drug pipelines, its market space is expected to be further released.

The original research enterprise of nortriptyline is Laboratoires Egic (one of the predecessor enterprises of Sandoz), and the original research trade name is Pamelor. The core compound patent in the United States expired in 1983. At present, the main dosage form of the original research marketed product is oral tablet, with specifications including 10mg, 25mg, 50mg and 75mg, which has been included in the FDA Reference Listed Drug Catalog. There is currently no registered DMF number for nortriptyline API in China, nor are there any approved nortriptyline-related preparation products marketed. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the actual R&D demand for nortriptyline, CATO can provide a full set of impurity reference standards for this API. Most of the 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 regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the generic drug R&D and quality research links of relevant pharmaceutical enterprises.