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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMICAR (aminocaproic acid) is an oral antifibrinolytic agent approved in 1964 that works by inhibiting plasminogen activators and antiplasmin activity to reduce fibrinolysis. It is indicated for conditions requiring inhibition of fibrinolytic activity, particularly in bleeding disorders and surgical bleeding prevention. The drug distributes across extravascular and intravascular compartments with renal excretion as the primary elimination route.
LOE Approaching
As a long-established oral generic approaching loss of exclusivity, the AMICAR brand team is likely small and focused on defending market position against generic competition with 45% competitive pressure.
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 minimal career momentum given zero linked job openings and approaching loss of exclusivity; opportunities are limited to legacy product management and defensive commercialization strategies. This product is best suited for professionals seeking stable, low-growth roles in mature portfolio management rather than high-impact or leadership-track positions.
Brand 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.