NDAORALFOR SUSPENSION, DELAYED RELEASE
Approved
Nov 2007
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
7
Data completeness
5/8 — Partial
PROTONIX (pantoprazole sodium) by Pfizer is 12. First approved in 2007.
Drug data last refreshed 12h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTONIX (pantoprazole sodium) is a proton pump inhibitor (PPI) that suppresses gastric acid production by covalently binding to the (H,K)-ATPase enzyme on gastric parietal cells. It is indicated for acid-reflux conditions including GERD and erosive esophagitis, with antisecretory effects persisting beyond 24 hours. The drug achieves 85% mean inhibition of gastric acid secretion at steady state with once-daily 40 mg dosing.
$0.015BPart D
LOE ApproachingDeclining
2mo to LOEProduct approaching loss of exclusivity with minimal Part D claims, signaling compressed team resources and shift toward legacy management rather than growth initiatives.
Mechanism 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.