NDAINJECTIONINJECTABLE
Approved
Feb 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
HEPARIN SODIUM (heparin sodium) by Fresenius Kabi is clinical pharmacology heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo . First approved in 1978.
Drug data last refreshed 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Heparin sodium is an injectable anticoagulant that inhibits blood clotting by enhancing antithrombin III activity to inactivate coagulation factors Xa and thrombin. It is indicated for venous thromboembolism, deep venous thrombosis, STEMI, and primary PCI. The drug works at multiple sites in the coagulation cascade to prevent fibrin clot formation without fibrinolytic activity.
LOE Approaching
As an older generic injectable approaching LOE, heparin teams are consolidating with focus on cost management and supply chain efficiency rather than growth-oriented expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo . Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can…
Indications
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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.