HEPARIN SODIUM
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
May 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
Priority Review
HEPARIN SODIUM by Hikma is protein, antithrombin iii, to induce a conformational change, which markedly enhances the serine protease activity of antithrombin iii, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly xa and iia. First approved in 1974.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Heparin Sodium is an injectable anticoagulant protein that enhances Antithrombin III activity to inhibit coagulation factors Xa and IIa, preventing thrombosis formation. It is indicated for venous thromboembolism, deep vein thrombosis, myocardial infarction, and COVID-19 management. Heparin does not dissolve existing clots but prevents their formation and expansion.
LOE Approaching
With LOE approaching and moderate competitive pressure (30/100), brand teams face declining market exclusivity and shrinking commercial opportunities as generics and newer anticoagulants dominate.
Mechanism of Action
protein, antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting 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.