IRON DEXTRAN
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Apr 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
IRON DEXTRAN by Sanofi is 12. Approved for older with documented iron deficiency, an unsatisfactory response to oral iron. First approved in 1957.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Iron dextran is an injectable iron replacement therapy administered via intramuscular or intravenous injection for iron deficiency anemia. It replenishes hemoglobin and depleted iron stores through physiologically controlled iron release. The drug is indicated for patients with documented iron deficiency who have had unsatisfactory responses to oral iron supplementation.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling a defensive commercial strategy and potential team rationalization.
Mechanism of Action
12.1 Mechanism of Action The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 12.2 Pharmacodynamics Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. After…
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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.