NDAINTRAVENOUSINJECTABLE
Approved
Nov 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
3/8 — Basic
VENOFER (iron sucrose) by Viatris is poly-nuclear iron (iii)-hydroxide in sucrose. First approved in 2000.
Drug data last refreshed 13h ago · AI intelligence enriched 16h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VENOFER (iron sucrose) is a parenteral iron replacement therapy administered intravenously to treat iron deficiency anemia, particularly in patients with chronic kidney disease on dialysis. The drug delivers poly-nuclear iron (III)-hydroxide complexed with sucrose, which dissociates post-injection and binds to transferrin for transport to erythroid precursor cells, where iron is incorporated into hemoglobin during red blood cell maturation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100) signals transition from growth maintenance to managed decline, typically requiring smaller, focused brand teams.
Mechanism of Action
poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into…
Pharmacologic Class:
Parenteral Iron Replacement
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects
Started Sep 2019
196 enrolled
Bioequivalance
Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty
Started Apr 2019
780 enrolled
Anemia, Iron Deficiency
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Started Nov 2016
1,538 enrolled
Iron Deficiency AnaemiaIron Deficiency AnemiaChronic Kidney Disease
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Started Nov 2016
1,512 enrolled
Iron Deficiency AnaemiaIron Deficiency Anemia
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
Started May 2014
511 enrolled
Iron Deficiency Anaemia
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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.