Desvenlafaxine

Major depressive disorder has become one of the psychiatric diseases with the highest disability rate worldwide, and clinical practice has long been faced with the pain points of slow onset and insufficient response rate of traditional antidepressants. Desvenlafaxine is an antidepressant of the serotonin and norepinephrine reuptake inhibitor (SNRI) class. It increases the concentration of the two neurotransmitters in the synaptic cleft by simultaneously inhibiting their reuptake, and has extremely low affinity for receptors such as dopamine and histamine, which can reduce adverse reactions such as drowsiness and weight gain. This drug is mainly used for the acute and maintenance treatment of major depressive disorder in adults, and can also be used as a first-line medication for generalized anxiety disorder in adults, especially suitable for depressed patients with somatic pain symptoms, and its clinical compliance is significantly better than that of traditional antidepressants.

Relevant data show that the market size of antidepressants in China exceeded 19 billion yuan in 2023, among which SNRI drugs accounted for more than 40%, making them the market segment with the highest share. As a representative third-generation SNRI drug, desvenlafaxine has achieved a compound annual market growth rate of 12.7% in the past three years, with the growth momentum mainly coming from the increase in the consultation rate of mental diseases and the clinical demand for drugs with low adverse reactions. At present, the original research product still accounts for nearly 60% of the domestic market, and more than 20 enterprises have obtained approval for generic drug preparations. Among them, 17 product specifications have been included in the national centralized procurement, with the maximum price reduction of winning bids exceeding 90% compared with the original research product, which has significantly improved patient accessibility.

The original research enterprise of desvenlafaxine is Pfizer, with the original brand name "Pristiq" (Chinese brand name "倍思乐"). Its US compound patent expired in 2022, and its core Chinese patent expired in 2023. The main dosage form approved for the original research product is extended-release tablets, with specifications of 50mg and 100mg, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there have been more than 30 registration records of desvenlafaxine API on the API registration platform of China CDE, among which more than 20 have obtained A status through the associated review with preparations. More than 20 domestic enterprises have obtained approval for the marketing of desvenlafaxine extended-release tablets, most of which have passed the consistency evaluation of generic drug quality and efficacy. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of desvenlafaxine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will 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 fully meet the full-process needs of API and preparation enterprises for quality research, declaration and registration, etc.