Fluoxetine

The global prevalence of depression is increasing year by year, and the demand for the diagnosis and treatment of mental illnesses continues to expand. As a commonly used selective serotonin reuptake inhibitor (SSRI) class of antidepressant in clinical practice, fluoxetine exerts its antidepressant effect by highly selectively inhibiting the reuptake of serotonin by the presynaptic membrane and increasing the concentration of serotonin in the synaptic cleft. It has minimal impact on norepinephrine and dopamine, and its cardiovascular and anticholinergic adverse reactions are relatively mild. Its indications cover mental illnesses such as depression, obsessive-compulsive disorder, bulimia nervosa, and panic disorder, and it can be used in adults, adolescents, and eligible pediatric patients, making it one of the core drugs in the global mental disease diagnosis and treatment system.

At present, the global market size of fluoxetine is stable at around US$3 billion, and the annual sales in the Chinese market exceed RMB 1.5 billion, with a compound annual growth rate of 4.2% in the past five years. After the patent of this variety expired, a large number of generic drugs were launched. Currently, generic drugs account for more than 85% of the domestic market, and more than 20 enterprises have obtained the production qualification of fluoxetine preparations. In 2022, the oral regular-release dosage forms of fluoxetine were included in the seventh batch of national centralized drug procurement, with an average price reduction of 69% for the selected products, which further promoted the improvement of clinical accessibility, and the demand for upstream API has also maintained a steady growth trend.

The original developer of fluoxetine is Eli Lilly and Company in the United States, with the original brand name "Prozac". Its core compound patent in the United States expired in 2001, and the compound patent in China expired in 1999. The main dosage forms of the original product include oral regular-release dosage forms, enteric-coated tablets and oral solutions. The regular-release tablets are available in 10mg and 20mg specifications, and the capsules are in 20mg specification. The original preparation has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. At present, there are more than 30 fluoxetine API registration numbers on the API registration platform of China's CDE, among which more than 10 are in status A (activated). A number of domestic enterprises have obtained approval for the marketing of fluoxetine preparations such as tablets, capsules and enteric-coated tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of fluoxetine impurity reference standards. Most products are regularly kept in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs in the links of API R&D, quality research and production.