NDAORALCAPSULE
Approved
Feb 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
5/8 — 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 2006.
Drug data last refreshed 4h ago · AI intelligence enriched 7h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGERID is an oral capsule combining omeprazole (a proton pump inhibitor) with sodium bicarbonate, designed to reduce the risk of upper gastrointestinal bleeding in critically ill patients. The sodium bicarbonate component enables faster omeprazole absorption compared to standard delayed-release formulations. It works by suppressing gastric acid secretion via inhibition of the H+/K+-ATPase pump in parietal cells.
$9MPart D
LOE ApproachingThis product is approaching loss of exclusivity with minimal Part D utilization (1,457 claims in 2023), indicating a niche ICU-focused market with limited team expansion opportunities.
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.