MEPHYTON
LOE ApproachingNDAORALTABLETPriority Review
Approved
Sep 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
MEPHYTON by Bausch + Lomb is clinical pharmacology mephyton tablets possess the same type and degree of activity as does naturally-occurring vitamin k, which is necessary for the production via the liver of active prothrombin (factor ii), proconvertin (factor vii), plasma thromboplastin component (factor ix), and stuart factor (factor x). Approved for the following coagulation disorders which are due to faulty formation of factors ii, interference with vitamin k activity. First approved in 1955.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEPHYTON is an oral vitamin K (phytonadione) tablet approved in 1955 for treating coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity. It works by serving as an essential cofactor for hepatic microsomal enzymes that produce active prothrombin and other vitamin K-dependent clotting factors (II, VII, IX, X). The drug typically exerts its effect within 6–10 hours of oral administration.
LOE Approaching
MEPHYTON faces imminent loss of exclusivity as a legacy product nearing patent expiration, likely limiting team expansion and innovation investments.
Mechanism of Action
CLINICAL PHARMACOLOGY Mephyton tablets possess the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor…
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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.