NDAORALCAPSULE, TABLET, CAPSULE, DELAYED RELEASE
Approved
Feb 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 21h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMECLAMOX-PAK is a fixed-dose combination of amoxicillin, clarithromycin, and omeprazole designed for oral administration as capsules and delayed-release tablets. This triple-therapy regimen targets Helicobacter pylori infection by combining two antibiotics with a proton pump inhibitor to eradicate the bacterium and reduce gastric acid. The combination leverages synergistic mechanisms to improve cure rates in patients with H. pylori-associated peptic ulcer disease.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30% intensity) suggests defensive commercial strategies and potential right-sizing of team resources.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on OMECLAMOX-PAK offers limited growth trajectory but provides valuable experience in mature-market management, generic competition navigation, and cost-containment strategy. Career advancement likely requires transition to growth-stage franchises within Cumberland Pharmaceuticals or lateral moves to other companies.
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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.