PANTOPRAZOLE SODIUM · Sun Pharma
Pantoprazole sodium is an injectable proton pump inhibitor indicated for the short-term treatment (up to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. It is also indicated for the management of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. It is intended for use when oral therapy is not appropriate.
How PANTOPRAZOLE SODIUM Works
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step of gastric acid production 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. Because of the irreversible nature of this covalent binding, the antisecretory effect persists for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2000-02-02
- Routes
- ORAL, INTRAVENOUS, INJECTION
- Dosage Forms
- TABLET, DELAYED RELEASE, INJECTABLE, FOR SUSPENSION, DELAYED RELEASE, POWDER
Companies
PANTOPRAZOLE SODIUM Approval History
What PANTOPRAZOLE SODIUM Treats
4 indicationsPANTOPRAZOLE SODIUM is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis (EE)
- Pathological hypersecretory conditions
- Zollinger-Ellison (ZE) Syndrome
PANTOPRAZOLE SODIUM 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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Sun Pharma'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.
PANTOPRAZOLE SODIUM 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...
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PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Full clinical data, patents, trials, and competitive landscape for pantoprazole sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.