COUMADIN
LOE ApproachingNDAORALTABLET
Approved
Jun 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
COUMADIN by Bristol Myers Squibb is k-dependent clotting factors, which include factors ii, vii, ix, and x, and the anticoagulant proteins c and s. First approved in 1954.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COUMADIN (warfarin) is an oral anticoagulant that has been the gold standard for thromboembolic disease prevention since 1954. It works by inhibiting vitamin K epoxide reductase (VKORC1), blocking the synthesis of vitamin K-dependent clotting factors (II, VII, IX, X) and anticoagulant proteins C and S. It is indicated for prevention and treatment of venous thrombosis, pulmonary embolism, and thromboembolic complications in patients with atrial fibrillation and mechanical heart valves.
LOE Approaching
Loss of exclusivity is imminent; brand teams are consolidating and shifting focus to defensive strategies and transition planning.
Mechanism of Action
K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Vitamin K promotes the biosynthesis of γ-carboxyglutamic acid residues in…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage
Started Jul 2009
54 enrolled
Intracranial Hemorrhages
Bioequivalence of IVAX Warfarin Tablets and Coumadin Brand Warfarin Tablets in Healthy Volunteers
Started Sep 2008
36 enrolled
Healthy
Career Relevance
COUMADIN roles are primarily focused on managing a mature, declining franchise and defending market share against DOACs in niche segments. Career advancement is limited; professionals should expect smaller teams, cost-control priorities, and eventual product phase-out or transition to specialty/legacy status.
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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.