Revaprazan

For gastric acid-related diseases, there have long been clinical pain points of slow onset of acid-suppressive drugs and poor control of nocturnal acid breakthrough. As a new generation of reversible potassium-competitive acid blocker (P-CAB), revaprazan breaks through the action limitations of traditional proton pump inhibitors. It can directly and reversibly bind to the potassium binding site of H+/K+-ATPase in gastric parietal cells without acid activation, and can achieve the maximum acid-suppressive effect within a few minutes. Its acid-suppressive effect is not affected by administration time. Clinically, it is mainly used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis, and can also be used in the combination regimen for Helicobacter pylori eradication, which is suitable for patient groups that need rapid control of gastric acid secretion and have poor response to traditional PPIs.

At present, the global market size of P-CAB drugs has exceeded 8 billion US dollars, with a compound annual growth rate of more than 22%. As the first marketed P-CAB variety, revaprazan is an important part of the market of this category of drugs. In the domestic market, only the original research manufacturer and a small number of enterprises have completed the layout at present. With the rising prevalence of digestive diseases and the increasing requirements of patients for acid suppression effect, the market penetration rate of revaprazan is gradually increasing, and the R&D enthusiasm of generic drug enterprises also continues to rise.

The original research enterprise of revaprazan is Yuhan Corporation of South Korea, and the original trade name is Revanex. The expiration date of its core compound patent in South Korea is 2026, and the compound patent in China expired in 2023. The main dosage form approved for the original product is tablet, with specifications including 20mg and 40mg. It has been included in the reference preparation catalogs of South Korea, Japan and other countries, and has not been included in the China Listed Drug Catalog Set yet. There is no revaprazan preparation approved for marketing in China for the time being. There is no publicly available domestic DMF registration number in A status in the API registration platform, and only a small number of enterprises are in the R&D and declaration stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

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