NDAORALSOLUTIONPriority Review
Approved
Jun 1964
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Data completeness
3/8 — Basic
Priority Review
AMICAR (aminocaproic acid) by Hikma. Approved for antifibrinolytic agent [epc]. First approved in 1964.
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMICAR (aminocaproic acid) is an oral antifibrinolytic agent approved in 1964 that works by inhibiting fibrinolysis to reduce bleeding. It is used to treat or prevent excessive bleeding in patients with hyperfibrinolysis or fibrinogenolysis, including those undergoing surgical procedures or with certain bleeding disorders.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and focused on defending market share against generic erosion with minimal growth investment.
Mechanism of Action
Pharmacologic Class:
Antifibrinolytic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on AMICAR offers limited career growth in a LOE-approaching lifecycle; roles are primarily defensive and cost-focused rather than high-visibility launch or expansion work. Best suited for professionals seeking stable, niche expertise in specialty/hospital settings or those managing generic transition.
Brand ManagerSpecialty Sales Representative
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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.