NDAINJECTIONINJECTABLEPriority Review
Approved
Mar 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug Shortage Active
HEPATOLITE is currently in shortage. Reason: Unavailable. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEPATOLITE is a radiopharmaceutical imaging agent containing Technetium Tc-99m Disofenin, used for hepatobiliary imaging to assess liver function and biliary tract patency. It is administered by injection and localizes in the liver and bile ducts, enabling scintigraphic visualization of hepatic clearance and biliary excretion.
LOE Approaching
Product faces imminent loss of exclusivity with declining franchise momentum; expect defensive commercial posturing and streamlined team structure.
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
HEPATOLITE offers limited career growth opportunities due to its LOE-approaching status and current shortage; roles tend to focus on regulatory compliance, supply stabilization, and legacy brand maintenance rather than innovation or expansion. Professionals joining this franchise should expect a consolidation mindset and steady-state operational responsibilities.
Regulatory Affairs Specialist
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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.