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Product introduction:

The original name of iprazole is iridazole, which was changed from the national pharmacopoeia in 2004 to iprazole. Compared with the existing prazole, it has the strongest anti acid activity, no individual difference in treatment, and effective control of nocturnal acid breakthrough. It can be used for other drugs to treat ineffective ulcers, and is expected to become the core product of PPI market.

市场价:

  • Product information
  • 产品描述
  • 参数配置


一、1、 Product introduction

Chinese Name

English Name

Declaration Type

Department

Reportable Dosage Form

Declaration Progress

Strength

CAS
艾普拉唑Ilaprazole5+4GastroenterologyTablet

Ready to declare

5mg172152-36-2

Indication】

      This product is suitable for the treatment of duodenal ulcer.


Reportable Dosage Form &Strength

      Enteric coated tablet:5mg 


Usage and Dosage

       Take 10 mg (2 tablets) once a day, once a day. The course of treatment is 4 weeks, or as directed.


Mechanism of Action

       

Eprazole is an irreversible proton pump inhibitor. After oral administration, eprazole selectively enters the gastric parietal cells and transforms into the subsulfonamide active metabolite, which interacts with the sulfhydryl group on H +, K + - ATPase to form the covalent binding of disulfide bond, irreversibly inhibits H +, K + - ATPase and produces the effect of inhibiting gastric acid secretion.


Development Progress】

            Our company is preparing the declaration materials, and it is expected to make a low declaration in 2017


Research and production at home and abroad】

       Apprazole and its enteric coated tablets were developed by Korea Yiyang Co., Ltd. in 2001. The Chinese mainland's Li Zhu group has declared its compound technology and research and development from the company in 2002. It was approved by the food and Drug Administration in December 2007. Its name is Yiran, the first listing in the world. The group is its exclusive production, processing and marketing in mainland China, Hongkong and Macao. Seller. According to the data of 22 sample hospitals in China, from the perspective of the sales trend from 2008 to 2012, the sales volume of iprazole was 870000 yuan in 2008, 10670000 yuan in 2011, and 24140000 yuan in 2012, with a year-on-year growth of 126.2%. The growth rate is fast. At present, there is only one sales volume of Lizhu group in the market. In addition, the dosage form upgrading project of eprazole enteric coated tablets of Lizhu group has entered phase III clinical trial, and only Jiangsu aosaikang Pharmaceutical Co., Ltd. has applied for eprazole sodium for injection.



2、 Product Character

    

1.) As a new proton pump inhibitor, eprazole is different from other proton pump inhibitors in pharmacology and pharmacokinetics due to its different substituents on pyrazole and benzimidazole rings. The longer half-life makes the efficacy of iprazole last longer and has a good effect on the prevention and control of acid breakthrough at night. The metabolism in human body is not affected by CYP2C19 gene polymorphism.


2. ) In clinical application, whether using iprazole alone or combined with antibiotics to treat peptic ulcer, its effect is better than that of the control drug. Under the same effect, the dosage of iprazole is smaller. Therefore, as a proton pump inhibitor, iprazole has a large market capacity and a good application prospect.


3. There is only one preparation listed in China, with few declaration manufacturers and little competition.

 


2、 Clinical Application

       

IL Yan's three-phase clinical trials in China showed that 10 mg of iprazole and 20 mg of omeprazole had similar effects in terms of safety, tolerance, etc., but the efficacy and effectiveness were very good. But in South Korea( ClinicalTrials.gov , 5 Jun 2014, http://clinicaltrials.gov/show/NCT02084420 )


Pantoprazole was taken as the control, and the expected clinical end point was reached finally, which showed that the efficacy, safety and tolerance of the two drugs were basically the same. In the second phase clinical (livzon-iy-81149r-09), the efficacy of 10 mg of eprazole and 15 mg of Esomeprazole in safety, efficacy, tolerance and other aspects is basically the same. (above from pjb database)


To sum up, we can know that the clinical efficacy, safety and tolerance of eprazole are not inferior to the representative proton pump inhibitors such as esomeprazole, omeprazole and pantoprazole, and the dosage is smaller.


4、 Patent information

        化合物专利WO-09523140已经过期,无核心专利限制本品种的开发,另外丽珠有一系列制备专利保护本品种,但都可以规避。


5、 Market capacity analysis

       According to IMS data, the domestic sales in 2013 was 55.01 million yuan, and in 2014 was 96.41 million yuan, with a growth rate of 75.26%. The total domestic market of proton pump inhibitors exceeded 15 billion yuan. In 2014, the domestic sales of omeprazole was 4.15 billion yuan, lansoprazole was 3.39 billion yuan, pantoprazole was 4.87 billion yuan, and esomeprazole was 1.56 billion yuan. However, the clinical efficacy, safety and tolerance of iprazole were not worse than those of the above four kinds of protons The future market share of pump inhibitors in the 15 billion cake depends on the marketing ability of the enterprise. At the same time, compared with esomeprazole, omeprazole and so on, there are a lot of repeated declarations, which is destined to be a white hot competition in the future. Now, only Lizhu has a monopoly on the domestic market, and only Jiangsu aosaikang has other declarations (iprazole sodium for injection).


3Domestic Declaration



类型

Reportable Dosage Form

Number of Declared Preparations

Number of Existing Preparation Enterprises 

5+4Table2 domesticdomestic




 Ilaprazole 艾普拉唑 CAS号:172152-36-2

Guangzhou Tosun Pharmaceutical Ltd

FL 4-5,No.3, 2nd Kehui street, Science Park, Guangzhou High-tech Industrial Development Zone, 

Tel: +86-20-66392521; Fax: +86-20-66392525

The original name of iprazole is iridazole, which was changed from the national pharmacopoeia in 2004 to iprazole. Compared with the existing prazole, it has the strongest anti acid activity, no individual difference in treatment, and effective control of nocturnal acid breakthrough. It can be used for other drugs to treat ineffective ulcers, and is expected to become the core product of PPI market.

The clinical effect is better than omeprazole, and the acid inhibition is more lasting

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