TheraRadar
Data updated: May 26, 2026

INJECTAFER (ferric carboxymaltose)

Trial Activity: Mature 4 active trials
Cardiovascular Approved 2013-07-25

INJECTAFER is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease; Heart Failure; Iron Deficiency.

Source: FDA Label • AM REGENT
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How INJECTAFER Works

This medication works by delivering a complex of iron (III) hydroxide and carboxymaltose, which is a carbohydrate polymer. Once administered, this polymer releases iron into the body to help restore necessary iron levels.

Source: FDA Label

Development Insights

American Regent, Inc. conducting 11 trials (19%)
70 indications explored (Broad Platform)
→ iron deficiency anemia (11 trials)
→ iron deficiency (9 trials)
→ anemia (8 trials)
5
Indications
--
Phase 3 Trials
1
Priority Reviews
12
Years on Market

Details

Status
Prescription
First Approved
2013-07-25
Patent Cliff
2028

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

AM REGENT
Active Ingredient: FERRIC CARBOXYMALTOSE

INJECTAFER Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
64 FDA actions from 2013 to 2025 · 3 indication expansions
Jan 2025 SUPPL
Label · Labeling
FDA Letter Label
May 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2022 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What INJECTAFER Treats

4 indications

INJECTAFER is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Iron Deficiency Anemia
  • Chronic Kidney Disease
  • Heart Failure
  • Iron Deficiency
Source: FDA Label

INJECTAFER Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LASIX ONYU
SQ INNOVATION
2025 2 indic.
IRON SUCROSE
INTL MEDICATION
2025 2 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to INJECTAFER

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AURYXIA
FERRIC CITRATE
2 shared
KERYX BIOPHARMS
Shared indications:
Chronic Kidney DiseaseIron Deficiency Anemia
FARXIGA
DAPAGLIFLOZIN
2 shared
AstraZeneca
Shared indications:
Chronic Kidney DiseaseHeart Failure
FERAHEME
FERUMOXYTOL
2 shared
AZURITY
Shared indications:
Iron Deficiency AnemiaChronic Kidney Disease
View all 20 similar drugs Pro
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Clinical Trial Registry

57 trials
Trial Sponsor ID Phase Status Title
NCT03817957 IDA-II TMP0916_03 Ph 3 completed Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency
NCT02632760 ITACS 605/15 Ph 4 completed Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
NCT07053475 IRONICA 24-11-18-Mufa-OralvsIV-Iron AR2059 Ph 4 recruiting IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
NCT01950247 results posted 1VIT13032 Ph 4 completed Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
NCT03833336 PREFER-HF PREFER-HF 2016-003604-31 Ph 3 completed Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)
NCT04625530 2020-01194; sp20Amstad Ph 3 withdrawn Perioperative Management in Gynaecological Carcinoma Surgery
NCT06686693 21-24HC (M-10949) 000000 Ph 4 recruiting Intravenous Iron Effects on Performance at High Altitude
NCT06080893 Istanbul Faculty of Medicine Ph 4 completed The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
NCT03680456 POREIIL TPL107 Ph 4 completed Postoperative Replacement of Intraoperative Iron Losses
NCT05744219 IRIS IRIS Ph 3 recruiting Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
NCT04087993 IDA-I TMP0916_02 Ph 3 withdrawn Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients
NCT03769441 EFFECT-KTx 201800450 Ph 3 completed Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation
NCT03037931 HEART-FID results posted 1VIT15043 Ph 3 completed Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
NCT05358509 RAPIDIRON 1811-03347 Ph 4 completed Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
NCT03991000 iCHF-2 iCHF-2 Ph 3 terminated Iron in Patients With Cardiovascular Disease
NCT04976179 IVON PACTR202012843695208 ISRCTN63484804, Investment ID INV-017271 Ph 3 completed Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)
NCT03218384 results posted 17-00444 Ph 2 terminated Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
NCT04968379 1VIT19046 Ph 2 withdrawn Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
NCT03632525 PID12800 Ph 4 completed Intravenous Iron in Adults With Cystic Fibrosis
NCT05477498 IRON-HFpEF 2018-02280 Ph 4 withdrawn Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction
NCT03523117 results posted 1VIT17044 Ph 3 completed Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
NCT01100879 AOC-MM FER-AOC-MM Ph 4 terminated Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy
NCT04269707 results posted 1VIT18045 Ph 3 completed Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
NCT02397057 results posted 1VIT14037 Ph 3 completed Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
NCT03759964 FCAACS CEHDF 1050 Ph 4 completed Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery
NCT03380520 IRON-CRT IRON-CRT Ph 4 completed Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
NCT02937454 Affirm-AHF results posted FER-CARS-06 2016-001467-36 Ph 4 completed Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
NCT03591406 results posted VIT-IRON-2011-004 Ph 3 completed To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
NCT02453334 IRON CLAD results posted 1VIT14039 Ph 3 completed Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
NCT03466983 P-Monofer-IBD-03 Ph 4 completed A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
NCT01513369 CLEVER CLEVER-2011 2011-005224-18 Ph 3 completed Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
NCT02905539 HOMe_aFers_1 P-0101 2015-004808-36, U1111-1176-4563 Ph 4 completed A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
NCT02086968 results posted 1VIT13035 Ph 4 completed Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
NCT02949947 results posted 2015-0588 NCI-2016-01925 Ph 2 terminated Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
NCT03191201 DIAFER 2016-01449 Ph 4 terminated A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
NCT03238911 results posted P-Monofer-IDA-04 Ph 3 completed Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT03237065 results posted P-Monofer-IDA-05 Ph 3 completed Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT04168346 IRONSTOMACH HUS/333/2019 Ph 4 not yet recruiting Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
NCT01692418 PREVENTT 12/0246 2012-002786-35, 10/104/06 Ph 3 completed Preoperative Intravenous Iron to Treat Anaemia in Major Surgery
NCT03399084 1637 FCM_1 Ph 1 completed A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
NCT01978028 Vifor-HF Ph 4 terminated Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
NCT02409459 results posted 1VIT14038 Ph 2 completed Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
NCT00704353 results posted 1VIT08021 Ph 3 completed Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
NCT00704028 results posted 1VIT08020 Ph 3 completed Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
NCT02009943 COMIRB 13-3151 Ph 1 withdrawn Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill
NCT03079518 Iron Turtle 16-047 Ph 2 completed Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency
NCT02125344 GBG 84 Ph 3 completed A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)
NCT01922479 PRACTICEASIAHF 2013/00265 IMU/BFA/2012/12 Ph 4 completed Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
NCT01701310 IVICA 11GS005 2011-002185-21, PB-PG-0110-21041 Ph 4 completed IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
NCT01787526 IronWoMan 1.0 2013-000327-14 Ph 3 completed Intravenous High Dose Iron in Blood Donors

Showing 50 of 57 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

INJECTAFER FDA Label Details

Indications & Usage

FDA Label (PDF)

INJECTAFER is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease; Heart Failure; Iron Deficiency.

View full patent landscape →
6 OB patents · 2 families · 124 international docs across 30 countries

INJECTAFER Patents & Exclusivity

Latest Patent: Feb 2028
Exclusivity: May 2026

Patents (6 active)

US7754702 Expires Feb 15, 2028
US7612109 Expires Feb 5, 2027
US8895612 Expires Jan 8, 2027
US11478502 Expires Jan 8, 2027
US11433091 Expires Jan 8, 2027
US11364260 Expires Jan 8, 2027

Exclusivity

I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
I-915 Until May 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for INJECTAFER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 360 active patents

Trial Analysis

  • • 57 total trials
  • • Stage: Mature

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA203565 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment