CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	University of Washington	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Australian and New Zealand Intensive Care Society Clinical Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Critical Care Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	McMaster University	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.

Clinical Trial Conditions for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	4
Healthy	4
Myocardial Infarction	4
Covid19	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Spain	11

Trials by US State

Trials by US State for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
GlaxoSmithKline	5
Ain Shams University	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	152
Industry	36
NIH	5

Last updated: July 28, 2026

Heparin Sodium 20,000 Units in Dextrose 5% in Plastic Container: Clinical Trials Update, Market Analysis, and Forecast

Heparin sodium 20,000 Units in Dextrose 5% in plastic container is a parenteral anticoagulant presentation used for therapeutic anticoagulation and catheter-related use in acute-care and inpatient settings. Public clinical-trials and FDA-exclusivity signals for this exact combination-strength-container presentation are not determinable from the available record set here, so a quantified trial-by-trial update and a defensible label-level forecast cannot be produced.

What clinical trials exist for heparin sodium in dextrose 5% plastic container?

No complete, presentation-specific clinical-trials dataset is available in the provided material to support a trial inventory (NCT numbers, endpoints, enrollment, phase, sites, dates) for heparin sodium 20,000 Units in Dextrose 5% in plastic container.

Phase and endpoint coverage by indication

No presentation-specific data available.

Trial status signals (recruiting, completed, results posted)

No presentation-specific data available.

How big is the market for heparin sodium injection formulations in D5W plastic containers?

A quantified market-sizing model for this exact strength-and-container presentation cannot be produced from the available record set. No validated revenue, unit, or market-share drivers are provided.

Hospital procurement and use-case segmentation

Heparin sodium products are typically purchased for:

• Therapeutic anticoagulation in inpatient settings
• Anticoagulation protocols in critical care
• Anticoagulation for line patency (institution-dependent)

No presentation-specific conversion factors (units per patient-day, average treatment duration, substitution rates between container types, or D5W vs NS compatibility policies) are available.

Pricing and reimbursement

No dataset provided for WAC, ASP, or net price for this exact presentation.

When does heparin sodium lose exclusivity or face generic substitution risk?

Heparin sodium is widely available as generic anticoagulant injection, with many products entering the market long ago. However, a presentation-specific exclusivity and patent timeline for “20,000 Units in Dextrose 5% in plastic container” cannot be produced without the relevant Orange Book listing, NDA/BLA linkage, and patent register.

Orange Book status of this exact presentation

No Orange Book listing data provided.

505(b)(2) vs ANDA pathway implications

No pathway and reference-product mapping provided.

What patents protect this heparin sodium presentation (20,000 units in D5W plastic container)?

A defensible patent estate map requires at minimum: the reference listed drug (RLD), application number (NDA), listed patents, assignees, and expiration dates. None is present in the available record set, so a “patents protecting” analysis would be incomplete.

What formulation patents exist for heparin sodium in dextrose solutions?

No formulation/preservation/stability patents or listed formulation-change patents are provided for this exact presentation.

Container-closure and stability considerations

No stability, compatibility, leachables, or shelf-life patent data is provided.

How does this product compare with other heparin sodium strengths and diluents (NS vs D5W; 10,000 vs 20,000 units)?

No side-by-side label, dosing equivalence data, concentration compatibility differences, or substitution evidence is provided.

Clinical practice substitution risk

No evidence provided for institutional switching between D5W and normal saline protocols for the same heparin dose.

Safety differentiation

No label-specific adverse event or monitoring differences are provided.

What patent litigation affects heparin sodium injection product presentations?

No litigation records, parties, case numbers, or settlement terms are included in the available record set for this exact presentation.

What FDA regulatory status applies to heparin sodium 20,000 units in D5W plastic container?

No FDA label, application number, approval history, manufacturing changes, or ongoing regulatory actions are available in the provided record set.

Manufacturing changes and recalls

No recall or quality-event record is provided.

How do biosimilars affect this heparin product market?

This product is a small-molecule anticoagulant injection, not a biologic for which “biosimilar” pathways apply. No biologics-to-heparin market interactions are relevant or provided.

Market forecast for heparin sodium 20,000 units in D5W plastic container (next 5 years)

A quantified 5-year forecast cannot be produced from the available record set because it lacks:

• Baseline unit demand or ASP/volume history for this exact presentation
• Switching/substitution constraints across container types and diluents
• Tendering dynamics and procurement concentration
• Regulatory and supply-chain stability signals tied to this SKU

Key Takeaways

• Presentation-specific clinical-trials and FDA/Orange Book-linked exclusivity and patent timelines cannot be produced from the available record set.
• Market sizing and 5-year forecasting for “Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container” cannot be quantified without presentation-level demand and regulatory listing data.
• Heparin sodium markets are generally sensitive to generic substitution, but a defensible forecast for this exact SKU requires the missing RLD, NDA/ANDA mapping, and historical procurement metrics.

FAQs

1. What is the Orange Book listing for heparin sodium 20,000 Units in Dextrose 5% in plastic container?
2. Which ANDAs or generics are approved for heparin sodium injection in D5W at 20,000 Units per container?
3. What are the label indications and dosing limits for this heparin sodium D5W presentation?
4. What are the key stability and compatibility considerations for heparin sodium mixed in D5W in plastic containers?
5. What supply constraints or quality events have affected heparin sodium injection products in the last 3 years?

References

1. (No citable sources provided in the available record set.)