NDAORALFOR SUSPENSION, DELAYED RELEASE
Approved
Nov 2007
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
7
Data completeness
6/8 — Strong
PROTONIX (pantoprazole sodium) by Pfizer is 12. Approved for gastroesophageal reflux disease, bleeding gastric ulcer, bleeding duodenal ulcer. First approved in 2007.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTONIX (pantoprazole sodium) is a proton pump inhibitor (PPI) available as a delayed-release oral suspension indicated for short-term treatment (up to 8 weeks) and symptomatic relief of erosive esophagitis in patients 18 years and older. The drug works by covalently binding to the (H,K)-ATPase enzyme system on gastric parietal cells, suppressing both basal and stimulated gastric acid secretion with an effect persisting longer than 24 hours. At the 40 mg once-daily dose, pantoprazole achieves 85% mean inhibition of gastric acid secretion after 7 days of dosing, with over 95% suppression in half of treated subjects.
$0.0BPart D
7mo to LOEMechanism of Action
12.1 Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H, K)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid…
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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.