Viloxazine

As a second-generation non-tricyclic antidepressant, viloxazine exerts its effect by selectively inhibiting norepinephrine reuptake, with minimal impact on the reuptake of 5-hydroxytryptamine and dopamine, and no anticholinergic effect. The risk of cardiovascular adverse reactions is significantly lower than that of traditional tricyclic drugs. Its clinical indications are mainly adult depression, and it can also be used to relieve depressive states accompanied by anxiety symptoms, especially suitable for elderly patients and people who cannot tolerate the anticholinergic side effects of tricyclic drugs. Some clinical studies have also shown that it has a certain improvement effect on neuropathic pain.

Against the background of the steady expansion of the global antidepressant market, norepinephrine reuptake inhibitors account for about 12% of the overall antidepressant market share. Viloxazine maintains stable clinical demand in Europe, Australia and other regions due to its advantage of side effects. At present, the competition of generic drugs of this variety is mainly concentrated in the EU market. There are no relevant preparations approved for marketing in China, and the market is in a blank stage, with considerable potential clinical replacement space. (The data has no verifiable public source and is for reference only)

The original research enterprise of viloxazine is Lundbeck of Denmark, and the original research trade name is Vivalan. Its core compound patent expired globally in 1997, and there is no valid core patent restriction at present. The main dosage form of the original research product is oral tablet, with specifications including 50mg and 100mg. It has been included in the reference preparation catalogues of many EU countries such as the United Kingdom and France, and has not been included in the *Catalogue of Chemical Pharmaceuticals* of China. Up to now, there is no valid registration number of viloxazine API on the platform of the Center for Drug Evaluation (CDE) of China, and no viloxazine preparation product has been approved for marketing in China for the time being. (The data is as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of viloxazine impurity reference standards, most of which are in stock. Orders for in-stock products 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 provide stable and reliable reference standard support for drug research and development, quality research and declaration links, helping relevant enterprises accelerate the domestic development process of this variety.