ZEGERID
LOE Approachingmagnesium hydroxide; omeprazole; sodium bicarbonate
NDAORALTABLET, CHEWABLE
Approved
Mar 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
ZEGERID (magnesium hydroxide; omeprazole; sodium bicarbonate) 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 2006.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGERID is an oral chewable tablet combining omeprazole (a proton pump inhibitor), magnesium hydroxide, and sodium bicarbonate for the treatment of gastric acid-related disorders. Omeprazole works by blocking the H+/K+ ATPase enzyme system in gastric parietal cells, suppressing both basal and stimulated acid secretion. The formulation allows rapid onset of action through the buffering agents while omeprazole provides sustained acid suppression.
$0.009BPart D
LOE ApproachingDeclining
Declining spending and approaching loss of exclusivity signal contraction phase requiring cost management and retention-focused commercial strategies.
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
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.