NDAINJECTIONINJECTABLE
Approved
Dec 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
HEPARIN SODIUM (heparin sodium) by B. Braun is protein, antithrombin iii, to induce a conformational change, which markedly enhances the serine protease activity of antithrombin ii, thereby inhibiting the activated coagulation factors involved in the closing sequence, particularly xa and iia. First approved in 1975.
Drug data last refreshed 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Heparin Sodium is an injectable anticoagulant that works by enhancing antithrombin III activity to inhibit coagulation factors Xa and IIa, preventing thrombus formation. It is indicated for venous thromboembolism, deep venous thrombosis, STEMI, and primary PCI. The drug does not lyse existing clots but prevents their development and stabilization.
LOE Approaching
As a product approaching loss of exclusivity with moderate competitive pressure (30/100), heparin sodium teams face resource constraints and transition planning—expect consolidation or shift to cost-leadership and volume strategies.
Mechanism of Action
protein, antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin II, thereby inhibiting the activated coagulation factors involved in the closing sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study With Heparin Sodium in Subcutaneous Administration
Started Aug 2022
Study With Heparin Sodium in Intravenous Administration
Started Feb 2021
Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)
Started May 2000
5,989 enrolled
Myocardial Infarction
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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.