MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
LOE Approachingmagnesium hydroxide; omeprazole; sodium bicarbonate
NDAORALTABLET
Approved
Dec 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE (magnesium hydroxide; omeprazole; sodium bicarbonate) by Santarus Inc is clinical pharmacology omeprazole is acid labile and thus rapidly degraded by gastric acid. Approved for heartburn, other symptoms associated with gerd. First approved in 2009.
Drug data last refreshed 48m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEGERID with Magnesium Hydroxide is a fixed-dose combination chewable tablet containing omeprazole (proton pump inhibitor), sodium bicarbonate, and magnesium hydroxide (antacid buffer). It treats heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) by rapidly raising gastric pH to protect acid-labile omeprazole from degradation, enabling fast absorption and onset of action. The buffered formulation allows omeprazole to be absorbed on an empty stomach with peak plasma concentrations achieved within approximately 30 minutes.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30); brand team likely focused on maximizing remaining exclusivity period and managing transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Omeprazole is acid labile and thus rapidly degraded by gastric acid. ZEGERID with Magnesium Hydroxide is an immediate-release chewable tablet formulation that contains an antacid component (sodium bicarbonate plus magnesium hydroxide) which raises the gastric pH and thus…
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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.