NDAORALCAPSULE, DELAYED RELEASE4 Generics Approved
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
60/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXIUM 24HR is an oral delayed-release capsule containing esomeprazole magnesium, a proton pump inhibitor that suppresses gastric acid secretion by blocking the H+/K+ ATPase enzyme system in gastric parietal cells. It is indicated for gastroesophageal reflux disease, heartburn, erosive esophagitis, and Zollinger-Ellison Syndrome. The drug works by inhibiting the final step of acid production, providing dose-dependent suppression of both basal and stimulated acid secretion.
Peak
NEXIUM 24HR is at peak lifecycle with moderate competitive pressure (60%), suggesting stable but non-growth commercial operations requiring efficient brand maintenance and market defense.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
Started Oct 2024
40 enrolled
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
Started Aug 2024
30 enrolled
Healthy Subjects
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Started Aug 2006
40 enrolled
Endoscopically-Proven GERDReflux
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Started Apr 2006
961 enrolled
AsthmaGERD
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Started Dec 2002
1,000 enrolled
Erosive Esophagitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.