NDAINTRAVENOUSSOLUTION
Approved
Jul 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
4/8 — Partial
INJECTAFER (ferric carboxymaltose injection) by Am Regent is (iii) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. First approved in 2013.
Drug data last refreshed 13h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INJECTAFER is a ferric carboxymaltose injection approved in 2013 for intravenous iron replacement in patients with iron deficiency anemia. It works by delivering iron(III) hydroxide complexed with carboxymaltose, a carbohydrate polymer that controls iron release to the reticuloendothelial system. The formulation enables rapid iron repletion with fewer infusions compared to traditional iron dextran products.
LOE Approaching1.4 years to LOE
Product is in late-stage patent life (1.4 years remaining) with moderate competitive pressure, indicating a consolidating brand team focused on transition planning rather than growth.
Mechanism of Action
(III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
Patent cliff in ~2 years — expect lifecycle management and generic defense hiring
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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.