NDAORALFOR SOLUTION
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELICOSOL (Urea C-13) is an oral diagnostic agent supplied as a powder for solution, used in breath tests to detect Helicobacter pylori infection in the gastroenterology setting. The C-13 isotope is non-radioactive, making it a safer alternative to C-14 or radioactive urea-based diagnostics. It works by measuring labeled CO2 in exhaled breath after oral administration, indicating active H. pylori colonization.
LOE Approaching
Mature diagnostic product approaching loss of exclusivity with low current hiring activity; commercial team focus is likely on pricing defense and cost management rather than expansion.
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 HELICOSOL offers limited career trajectory in a mature, commoditized diagnostic franchise approaching or past patent expiration. Roles are primarily operational and compliance-focused rather than strategic or growth-oriented, suitable for professionals seeking stable specialty pharma work in diagnostics or manufacturing.
Regulatory Affairs SpecialistSupply Chain Manager
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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.