NDAORALFOR SUSPENSION
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
ZEGERID (omeprazole; sodium bicarbonate) by PharmaIN is compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the h+/k+ atpase enzyme system at the secretory surface of the gastric parietal cell. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGERID is an oral suspension combining omeprazole with sodium bicarbonate, a proton pump inhibitor that suppresses gastric acid secretion by blocking the H+/K+ ATPase enzyme system in gastric parietal cells. It is indicated for acid-reflux conditions and works by inhibiting both basal and stimulated acid secretion regardless of the stimulus. The sodium bicarbonate component enables rapid onset of action compared to omeprazole alone.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting defensive commercial strategy and potential team consolidation opportunities.
Mechanism of Action
compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.