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Product introduction:

Esomeprazole magnesium,  is a (s) - (-) - type single enantiomeric magnesium salt preparation of omeprazole, which was developed by Astra Zeneca in Sweden and listed in China in 2004. It is a new proton pump inhibitor that can inhibit H + / K + - ATP Enzyme activity, mainly used in the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis and other digestive system diseases caused by excessive gastric acid secretion.



市场价:

  • Product information
  • 产品描述
  • 参数配置


1、 Product introduction

Chinese Name

English Name

Declaration Type

Department

Reportable Dosage Form

Declaration Progress 

Patent TermCAS
埃索美拉唑镁Esomeprazole magnesium5+4astroenterologyTablet

Already accepted

Compound patent up to 2014161973-10-0

Indication】

1. Gastroesophageal reflux disease (GERD).


2. Treatment of erosive reflux esophagitis.


3. Long term maintenance treatment to prevent recurrence of cured esophagitis patients.


4. Symptoms control of gastroesophageal reflux disease (GERD) and appropriate antimicrobial therapy were combined to eradicate Helicobacter pylori.


5. Healing of duodenal ulcer related to Helicobacter pylori infection.


6. Prevent the recurrence of peptic ulcer related to Helicobacter pylori.


Reportable Dosage Form &Strength

  Enteric coated tablet:20mg\40mg


Usage and Dosage

   

Tablets should be swallowed whole with liquid, not chewed or crushed.


1) Treatment of erosive reflux esophagitis, 40 mg once a day for four weeks.

2) It is recommended that patients with untreated or persistent symptoms of esophagitis take another four weeks of medication. The long-term maintenance treatment to prevent recurrence of cured esophagitis patients, 20mg once a day.

3) Symptoms of gastroesophageal reflux disease (GERD) were controlled once a day in 20 mg patients without esophagitis. If the symptoms are not controlled within 4 weeks, the patient should be further examined. Once symptoms are eliminated, immediate treatment can be used for subsequent symptom control, i.e. oral administration of 20mg once a day when necessary.

4) To eradicate Helicobacter pylori and heal the duodenal ulcer associated with Helicobacter pylori, and prevent the recurrence of peptic ulcer associated with Helicobacter pylori, esomeprazole 20mg + amoxicillin 1g + clarithromycin 500mg, twice a day for 7 days.


Mechanism of Action 

     Esomeprazole is the S-isomer of omeprazole. It is a specific inhibitor of proton pump in parietal cells. Esomeprazole is a weak base, which is concentrated in the high acid environment of the acid secreting microtubules of parietal cells and transformed into the active form, thus inhibiting the H + / K + - ATPase (proton pump) of the site, and inhibiting the basic gastric acid secretion and the stimulated gastric acid secretion.


Development Progress】

        Our company has applied for import registration of raw materials and obtained the acceptance number.


Research and production at home and abroad】

       

1. )Esomeprazole is the next generation product of omeprazole due to its rapid development and huge market share;

2. )National medical insurance varieties;

3. )Esomeprazole patent has expired. AstraZeneca launched the replacement product of omeprazole, esomeprazole, in 2002, and became the fastest growing PPI product in the world. In 2005, the sales volume in the U.S. market reached 

4.) 4 billion US dollars, and the global sales volume was close to 6 billion US dollars.

The product was launched in China at the beginning of 2003 under the trade name of Naixin and was protected by patent technology until 2014. The growth of the product is very rapid. In 2003, the drug accounted for only 1.1% of the total PPI market, reached nearly 8% in 2006, and the average growth rate in three years is close to 200%. Nexant entered the national medical insurance catalog in November 2004. It can be predicted that in the next few years, with the continuous deepening of the academic promotion of AstraZeneca, its share in the domestic hospital market will further expand.


2、 Product Character

1. Esomeprazole is the next generation product of omeprazole due to its rapid development and huge market share;

2. National medical insurance varieties;

3. Esomeprazole patent has expired.


 3、Clinical Advantages 

     Clinical gastric acidity (pH value) is the most important factor determining the efficacy of drugs on GERD and ulcer. It is generally believed that the pH value of GERD should be kept at 4.0 or above in most of the time, and the pH value of peptic ulcer healing should be at 3.5 or above. All the drugs with strong inhibition of gastric acid and time are of the best effect. 24hph monitoring in stomach was used to evaluate the acid inhibition effect of PP1, which was basically consistent with the clinical trial, indicating that the effect of 2O and 40mg of this product was better than that of omeprazole 20mg. Compared with lansoprazole, pantoprazole and dulazol, this product also has stronger acid inhibition.


4、 Patent information

        Esomeprazole patent expires in 2014, patent No.: 94190335.4, which protects Na +, Mg2 +, Li +, K +, Ca2 + and N + (R) 4 salts.


5、 Quality comparison


1.) The results of comparison between our raw material standard and bp2013 are as follows: it is consistent, and the detection range of specific rotation is better than BP;

2.)Our raw material standard is consistent with usp35-nf30;

3.) The results of comparison between our raw material standard and ep8.0: it is consistent, and the detection range of specific rotation is better than EP; chp2010 edition is not included.


6、 Original manufacturer and time of listing

Esomeprazole magnesium埃索美拉唑镁 CAS:161973-10-0

        The original manufacturer AstraZeneca, in 2000, the oral preparation of esomeprazole was first listed in Sweden, and in 2001, it was approved by FDA to be listed in the United States, with the trade name of Nexium. In 2003, esomeprazole sodium for injection developed by AstraZeneca was first listed in Sweden and approved to be listed in the United States in 2005.


7、Domestic Declaration


Declaration Type

Reportable Dosage Form

Number of Declared Preparation 

Number of Existing Preparation Enterprises

5+4Tablet
45 domestic 7 importedimported &  1domestic

 Esomeprazole magnesium埃索美拉唑镁 CAS:161973-10-0

Guangzhou Tosun Pharmaceutical Ltd

FL 4-5,No.3, 2nd Kehui street, Science Park, Guangzhou High-tech Industrial Development Zone, Guangzhou, China. 510663

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

Esomeprazole magnesium,  is a (s) - (-) - type single enantiomeric magnesium salt preparation of omeprazole, which was developed by Astra Zeneca in Sweden and listed in China in 2004. It is a new proton pump inhibitor that can inhibit H + / K + - ATP Enzyme activity, mainly used in the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis and other digestive system diseases caused by excessive gastric acid secretion.



Upgraded omeprazole with large market share

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