PROTONIX (pantoprazole sodium)
Protonix (pantoprazole sodium) for injection is indicated for adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis for a treatment duration of up to 10 days. It is also indicated for the management of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. This injectable formulation is intended for use when oral therapy is not feasible. Its safety and effectiveness for the treatment of upper gastrointestinal bleeding have not been established.
How PROTONIX Works
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step of gastric acid production. It works by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of gastric parietal cells. This action inhibits both basal and stimulated gastric acid secretion, regardless of the stimulus. The covalent bond results in an antisecretory effect that persists for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2000-02-02
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, FOR SUSPENSION, DELAYED RELEASE
PROTONIX Approval History
What PROTONIX Treats
4 indicationsPROTONIX is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathological Hypersecretory Conditions
- Zollinger-Ellison Syndrome
PROTONIX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PROTONIX
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROTONIX FDA Label Details
Indications & Usage
FDA Label (PDF)PROTONIX is indicated for the treatment of Gastroesophageal Reflux Disease; Erosive Esophagitis; Pathological Hypersecretory Conditions; Zollinger-Ellison Syndrome.
PROTONIX Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for PROTONIX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 15 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.