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 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COUMADIN (warfarin) is an oral anticoagulant approved in 1954 that inhibits vitamin K-dependent clotting factors (II, VII, IX, X) and anticoagulant proteins C and S. It works by blocking the VKORC1 enzyme complex, preventing the regeneration of vitamin K and reducing synthesis of clotting factors. COUMADIN is indicated for thromboembolism prevention and treatment across multiple cardiovascular and thromboembolic conditions.
LOE Approaching
As a product nearing loss of exclusivity with moderate competitive pressure (30% intensity), the brand team is likely focused on retention strategies and managed decline rather than growth initiatives.
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 careers are concentrated in managed decline and market defense roles within Bristol Myers Squibb's anticoagulation portfolio. Positions tend to focus on payer negotiations, patient retention, and leveraging the drug's historical safety data against DOAC competition rather than growth-oriented commercial development.
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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.