TheraRadar
Data updated: May 26, 2026

TRIFERIC (ferric pyrophosphate citrate)

Trial Activity: Declining
Other Approved 2015-01-23
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Rockwell Medical Technologies, Inc. conducting 9 trials (100%)
6 indications explored (Moderate)
→ end stage renal disease (6 trials)
→ iron-refractory iron-deficiency anemia (1 trials)
→ peritoneal dialysis (pd) (1 trials)
2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2015-01-23
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
POWDER, SOLUTION

Companies

ROCKWELL MEDICAL INC
Active Ingredient: FERRIC PYROPHOSPHATE CITRATE

TRIFERIC Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2015 to 2019
Jul 2019 SUPPL
Label · Labeling
FDA Letter
Mar 2018 SUPPL
Label · Labeling
FDA Letter Label
Oct 2017 SUPPL
Label · Labeling
FDA Letter Label

What TRIFERIC Treats

2 FDA approvals

Originally approved for its first indication in 2015 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT04409132 RMFPC-26 Ph 1, Ph 2 completed Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
NCT04042324 results posted RMFPC-24 Ph 1, Ph 2 completed A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
NCT03303144 results posted RMFPC-20 Ph 1, Ph 2 completed Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
NCT02905981 results posted RMFPC-15 Ph 2 terminated Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol
NCT02636049 RMFPC-12 results posted RMFPC-12 Ph 1 completed Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
NCT02909153 results posted RMFPC-17 Ph 1 completed Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
NCT02739100 results posted RMFPC-16 Ph 1 completed Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
NCT02767128 results posted RMFPC-18 Ph 1 completed Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
NCT02595437 results posted RMFPC-11 Ph 1, Ph 2 completed Triferic Pediatric Pharmacokinetic Protocol
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

TRIFERIC FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 17 international docs across 12 countries

TRIFERIC Patents & Exclusivity

Latest Patent: Apr 2029

Patents (2 active)

US7816404 Expires Apr 17, 2029
US7857977 Expires Sep 8, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TRIFERIC

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 4 active patents

Trial Analysis

  • • 9 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208551 → 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