NDAINJECTIONINJECTABLE
Approved
Jun 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AQUAMEPHYTON (phytonadione) by R-Pharm US is 1 for parenteral injection, possesses 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: • anticoagulant-induced hypoprothrombinemia caused by coumarin, indanedione derivatives and 1 more indications. First approved in 1960.
Drug data last refreshed 3h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AQUAMEPHYTON (phytonadione) is a parenteral vitamin K1 replacement therapy that restores hepatic synthesis of vitamin K-dependent clotting factors II, VII, IX, and X. It is indicated for anticoagulant-induced hypoprothrombinemia from coumarin or indanedione derivatives, and certain coagulation disorders and ulcerative colitis. The drug works by serving as a cofactor for hepatic carboxylation of inactive precursor proteins into active coagulation factors.
LOE Approaching
Product is approaching loss of exclusivity with minimal current commercial spending data; team size likely modest and focused on defending heritage brand against generic competition.
Mechanism of Action
1 for parenteral injection, possesses 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…
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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.