NDAORALFOR SUSPENSION, DELAYED RELEASE
Approved
Mar 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
PRILOSEC (omeprazole magnesium) by R-Pharm US 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 2008.
Drug data last refreshed 19h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRILOSEC (omeprazole magnesium) is an oral proton pump inhibitor that suppresses gastric acid secretion by blocking the H/K-ATPase enzyme system in gastric parietal cells. It treats gastroesophageal reflux disease (GERD), peptic ulcer disease, and related acid-related conditions. The delayed-release formulation allows targeted delivery to the small intestine for optimal acid suppression.
$0.003BPart D
LOE ApproachingDeclining
Mature product approaching loss of exclusivity with modest Part D volume; brand defense and transition planning will drive team focus.
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 (13)
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
Started Oct 2024
40 enrolled
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
Started Aug 2024
30 enrolled
Healthy Subjects
Prilosec Bioequivalence Study in Healthy Volunteers
Started Aug 2013
54 enrolled
Bioequivalence, AUC, Cmax, Pharmacokinetics
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
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Started Sep 2008
24 enrolled
Healthy Volunteers
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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.