ESOMEPRAZOLE MAGNESIUM · Cipla
Esomeprazole magnesium is a proton pump inhibitor indicated for the short-term healing of erosive esophagitis (EE) in adults and pediatric patients (ages 12–17) and the maintenance of healing of EE in adults. It is used for the short-term treatment of heartburn and other symptoms of gastrointestinal reflux disease (GERD) in both adults and adolescents. Additionally, it is indicated to reduce the risk of NSAID-associated gastric ulcers in patients aged 60 and older or those with a history of ulcers. For *Helicobacter pylori* eradication, it is used in combination with amoxicillin and clarithromycin to reduce the risk of duodenal ulcer recurrence. It is also indicated for the long-term treatment of pathological hypersecretory conditions, such as Zollinger-Ellison syndrome.
How ESOMEPRAZOLE MAGNESIUM Works
Esomeprazole is a substituted benzimidazole that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system (the proton pump) at the secretory surface of the gastric parietal cell. It is a weak base that is concentrated and converted to its active form, an achiral sulphenamide, within the acidic environment of the parietal cells. This active form binds to the enzyme system, blocking the final step of acid production. This effect inhibits both basal and stimulated gastric acid secretion, regardless of the stimulus.
Details
- Status
- Prescription
- First Approved
- 2001-02-20
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, CAPSULE, DELAYED RELEASE, FOR SUSPENSION, DELAYED RELEASE, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, TABLET, DELAYED RELEASE
Companies
ESOMEPRAZOLE MAGNESIUM Approval History
What ESOMEPRAZOLE MAGNESIUM Treats
8 indicationsESOMEPRAZOLE MAGNESIUM is approved for 8 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erosive Esophagitis
- Heartburn
- Gastroesophageal Reflux Disease
- Gastric Ulcer
- Helicobacter Pylori Infection
- Duodenal Ulcer
- Zollinger-Ellison Syndrome
- Pathological Hypersecretory Conditions
ESOMEPRAZOLE MAGNESIUM Competitive Set
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01135472 | 08197 | Ph 1 | completed | Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers |
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ESOMEPRAZOLE MAGNESIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. Maintenance of healing of EE in adults. Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (6...
ESOMEPRAZOLE MAGNESIUM Patents & Exclusivity
Patents (2 active)
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2036
- • 2 active patents
Trial Analysis
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Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.