PROTONIX IV (pantoprazole sodium) · Pfizer
Protonix IV helps adults manage gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. It is used for short-term care, specifically for up to 10 days. Additionally, it treats pathological hypersecretory conditions like Zollinger-Ellison Syndrome in adult patients.
How PROTONIX IV Works
This drug works by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of gastric parietal cells. This binding suppresses the final step of gastric acid production, which inhibits both basal and stimulated acid secretion. The resulting effect on stomach acid lasts for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2001-03-22
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
PROTONIX IV Approval History
What PROTONIX IV Treats
4 indicationsPROTONIX IV is approved for 4 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathological Hypersecretory Conditions
- Zollinger-Ellison Syndrome
PROTONIX IV 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.
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Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 IV FDA Label Details
Indications & Usage
FDA Label (PDF)Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s...
PROTONIX IV Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.