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 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Iron dextran is an injectable iron replacement therapy indicated for iron deficiency anemia in patients with documented iron deficiency or unsatisfactory response to oral iron. It works by releasing circulating iron that replenishes hemoglobin and depleted iron stores under physiological control. The drug is absorbed via intramuscular or intravenous injection with iron components metabolized by the reticuloendothelial system.
LOE Approaching
Legacy product approaching loss of exclusivity with limited commercial growth opportunities and likely small, stable brand team.
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.