Ilaprazole

Acid-related diseases such as peptic ulcer and reflux esophagitis have long plagued more than 1 billion patients worldwide, and acid suppression therapy is the core intervention for such diseases. Ilaprazole is a new generation of proton pump inhibitor, which irreversibly inhibits the activity of H+/K+-ATPase in gastric parietal cells and blocks the final step of gastric acid secretion. Compared with the first-generation PPI, it has the advantages of longer-lasting acid suppression effect, less individual difference and fewer drug interactions. It is mainly used clinically to treat duodenal ulcer, gastric ulcer and reflux esophagitis, and can also be used in the combination therapy for Helicobacter pylori eradication, especially suitable for elderly patients and people who concurrently take cardiovascular drugs such as clopidogrel, and can effectively reduce the risk of acid-related complications.

At present, the market size of domestic ilaprazole-related preparations has exceeded 4 billion yuan, with a compound annual growth rate of more than 15% in the past three years, making it one of the PPI varieties with the fastest growth rate in the field of gastroenterology. In terms of the competitive landscape, the original research product has long occupied more than 90% of the market share. With the expiration of core patents, oral preparations of 3 domestic enterprises have passed the consistency evaluation of generic drugs, and 2 enterprises have also obtained approval for the marketing of injection dosage forms. After the implementation of centralized procurement, the drug accessibility is expected to be further improved, driving the continuous expansion of demand for upstream API.

The original research enterprise of ilaprazole is Il-Yang Pharmaceutical Co., Ltd. of South Korea, with the original trade name of "Yili'an". Its core compound patent in China expired in 2022, and its preparation patent will expire in 2030. The main dosage forms of the original research approved in China include enteric-coated tablets (5mg specification) and ilaprazole sodium for injection (10mg specification), both of which have been included in the Catalogue of Marketed Drugs in China as reference preparations. In terms of API registration, there are currently 7 registered APIs publicly announced by CDE, among which 4 are in Class A status, which can be used in association with domestic preparation declarations. There are 6 ilaprazole preparation varieties approved for marketing in China. (Data as of July 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for ilaprazole API. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most of them are in stock. Orders placed before 16:00 can be shipped on the same day, which can fully cover the reference material use needs of pharmaceutical enterprises in all stages of drug R&D, quality research and declaration and registration.