EsCitalopram

For core symptoms such as depressed mood and anhedonia associated with major depressive disorder, highly selective serotonin reuptake inhibitors (SSRIs) have become the first-line treatment regimen in clinical practice, and escitalopram is one of the varieties with the highest target selectivity among this class of drugs. It specifically inhibits the reuptake function of the serotonin transporter to increase the concentration of serotonin in the synaptic cleft, thereby exerting antidepressant and anti-anxiety effects. In addition to adult major depressive disorder, it can also be used for the treatment of adult panic disorder, social anxiety disorder, and generalized anxiety disorder, and is especially suitable for the elderly patient population who require long-term maintenance treatment and have high requirements for drug tolerance.

The global market size of antidepressant drugs has exceeded 15 billion US dollars, among which the peak annual sales of escitalopram have exceeded 3 billion US dollars, making it one of the most widely used antidepressant drugs in the world. The market size of escitalopram at the terminal of Chinese public medical institutions is close to 2 billion yuan, with an annual compound growth rate remaining at around 6%. With the successive launch of generic drugs after patent expiration, more than 20 domestic enterprises have had their generic drugs pass the consistency evaluation. This variety has been included in the national centralized volume-based procurement, and the winning price has dropped by more than 90% compared with the original research drug, greatly improving the accessibility of the drug.

The original research enterprise of escitalopram is Lundbeck, with the trade name "Lexapro". The expiration date of its core compound patent in Europe is 2012, the expiration date of the US patent is 2014, and the Chinese compound patent expired in 2012. The main dosage form approved for the original research drug is oral tablet, with specifications including 5mg, 10mg and 20mg. Its preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, there are currently nearly 30 registration numbers of escitalopram API including the original research product, among which more than 20 are in status A and can be used for associated preparation declaration. A number of domestic manufacturers have obtained approval for the marketing of escitalopram tablets and oral solutions. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for escitalopram API, fully covering impurities in the synthesis process, degradation impurities and enantiomeric impurities. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products have sufficient spot inventory, and spot orders placed before 16:00 can be shipped on the same day, fully meeting the use needs of impurity reference standards in the process of drug R&D, quality research and production.