NDAINTRAVENOUSINJECTABLE
Approved
Mar 2001
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
6
Data completeness
5/8 — Partial
PROTONIX IV (pantoprazole sodium) by Pfizer is 12. Approved for gastroesophageal reflux disease, gastric ulcer, duodenal ulcer. First approved in 2001.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTONIX IV (pantoprazole sodium) is an intravenous proton pump inhibitor that suppresses gastric acid secretion by covalently binding to the H+/K+-ATPase enzyme at the parietal cell secretory surface. It is indicated for gastroesophageal reflux disease, gastric ulcer, and duodenal ulcer, providing acid inhibition >95% in half of treated subjects with effects persisting >24 hours.
$0.024BPart D
LOE ApproachingDeclining
1.3 years to LOELate-stage product with declining trajectory; teams typically smaller and focused on margin defense and generic transition planning.
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.