NDAORALTABLET, DELAYED RELEASE4 Generics Approved
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
60/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXIUM 24HR is an over-the-counter proton pump inhibitor (PPI) containing esomeprazole magnesium in delayed-release tablet form. It reduces stomach acid production to treat frequent heartburn and acid reflux symptoms. This OTC formulation represents a shift from prescription-only PPI therapy to consumer self-management of GERD.
Peak
Product is at peak commercial maturity with significant competitive pressure (60/100), indicating mature marketing execution and potential team stability or consolidation.
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.