NDAORALFOR SUSPENSION
Approved
Jun 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
ZEGERID (omeprazole, sodium bicarbonate) by Salix Pharmaceuticals is proton pump inhibitors [moa]. Approved for sodium bicarbonate for oral suspension is indicated in adults for: reduction of risk of upper gastrointestinal (gi) bleeding in critically ill patients ( ). First approved in 2004.
Drug data last refreshed 14h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGERID is an oral suspension combining omeprazole (a proton pump inhibitor) with sodium bicarbonate, approved in 2004 for reducing the risk of upper GI bleeding in critically ill patients. The sodium bicarbonate component enables rapid acid neutralization and faster omeprazole absorption compared to standard formulations. It works by irreversibly inhibiting gastric acid secretion through H+/K+-ATPase inhibition.
LOE Approaching
With LOE approaching and competitive pressure at 30%, teams supporting ZEGERID face a narrowing commercial window requiring focus on retention and cost management rather than growth expansion.
Mechanism of Action
Proton Pump Inhibitors
Pharmacologic Class:
Proton Pump Inhibitor
Clinical Trials (6)
Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
Started Apr 2011
239 enrolled
Gastroesophageal Reflux
A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12)
Started Jan 2011
50 enrolled
Heartburn
A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions
Started Oct 2010
20 enrolled
Acid RefluxGastro Oesophageal Reflux Disease
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Started May 2008
60 enrolled
Gastric AcidHuman Experimentation
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Started Apr 2008
60 enrolled
Gastric AcidHuman Experimentation
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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.