Esomeprazole

Abnormal gastric acid secretion is the core inducing factor for upper gastrointestinal diseases such as gastroesophageal reflux disease and peptic ulcer, and proton pump inhibitors are currently the cornerstone of clinical acid suppression therapy. As a new generation of proton pump inhibitor, esomeprazole is the S-isomer of omeprazole. It specifically targets the proton pump of gastric parietal cells, blocks the final step of gastric acid secretion by inhibiting the activity of H+/K+-ATPase, has stronger and longer-lasting acid suppression effect, and is applicable to the treatment of gastroesophageal reflux disease, Helicobacter pylori eradication, gastric ulcer and duodenal ulcer in adults and adolescents. It can also be used to prevent gastric mucosal injury associated with non-steroidal anti-inflammatory drugs, and is currently a first-line commonly used drug for acid suppression therapy.

At present, the global market size of esomeprazole exceeds 6.5 billion US dollars, the annual sales in the Chinese market exceed 8 billion yuan, and the compound annual growth rate remains at about 4.2%. Due to the stable clinical demand and the rapid entry of generic manufacturers after the patent expiration, the domestic market presents a pattern of coexistence of original research drugs and generic drugs. There are more than 40 approved generic preparations in China. After the implementation of centralized procurement, the terminal price has dropped by more than 70%, the accessibility of the primary market has been greatly improved, and the demand for upstream API has continued to rise accordingly.

The original research enterprise of esomeprazole is AstraZeneca, and the original research trade name is "Nexium". Its US compound patent was first approved in the US in 2000. The core compound patent expires in 2014 in the US, and the core patent expires in 2018 in China. The main dosage forms of the original research product include enteric-coated tablets and injections, with specifications covering two commonly used specifications of 20mg and 40mg. The original research preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA. At the same time, more than 30 domestic esomeprazole APIs have passed the CDE registration, and the approved domestic preparation varieties have covered multiple dosage forms such as oral administration and injection. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for esomeprazole API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, quality research and quality control.