Eprazinone

In the clinical selection of non-addictive antitussive and expectorant drugs for respiratory system, eprazinone occupies a unique position by virtue of its dual mechanism of action. It has both central and peripheral antitussive effects. On the one hand, it can directly inhibit the cough center of the medulla oblongata, with antitussive intensity close to that of codeine but no risk of addiction. On the other hand, it can promote the secretion of bronchial mucosa, lyse the acidic mucopolysaccharide fibers in sticky sputum, reduce sputum viscosity, and also have certain antihistamine and anti-inflammatory effects, which can relieve bronchial mucosal edema. It is mainly used clinically for cough and expectoration symptoms caused by acute and chronic bronchitis, pneumonia, tuberculosis and other diseases, and is suitable for patients of all ages who need long-term antitussive and expectorant treatment and are worried about addiction, especially for the symptom management of elderly and pediatric people with respiratory diseases.

At present, the domestic market size of eprazinone is stable at around 300 million yuan, with a compound annual growth rate of approximately 4.2% in the past three years, and the growth momentum mainly comes from the release of diagnosis and treatment demand for chronic respiratory diseases in primary medical institutions. The competitive landscape is dominated by generic drugs, and no original research product has been marketed in China. There are less than 10 existing manufacturers, with a high market concentration, and the top two enterprises account for nearly 70% of the market share. As this variety has not been included in the national centralized volume-based procurement, the price system is relatively stable, and the compliance and production capacity stability of the API supply end have become one of the core competitive factors for preparation enterprises.

The original research enterprise of eprazinone is Japan Seiko Eiyo Pharmaceutical Co., Ltd., and the original research trade name is "Yikeqin". Its core compound patent expired globally in 1999. The main dosage form approved by the original research is tablet with a specification of 40mg. This product specification has been included in the Japanese Orange Book as a reference listed drug, and has not yet been included in the Chinese *Catalogue of Reference Listed Drugs for Chemical Drugs*. In terms of domestic API registration, as of the retrieval time point, there are 3 valid API registration numbers with A status, all from domestic manufacturers. Two preparation dosage forms, namely eprazinone hydrochloride tablets and eprazinone capsules, have been approved for marketing by NMPA. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for eprazinone, fully covering impurities in the synthesis process, degradation impurities and solvent residual reference standards. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-scenario needs of API research and development, quality research and routine production testing.