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TRIFERIC

NDA

FERRIC PYROPHOSPHATE CITRATE | N206317 | ROCKWELL MEDICAL INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

7816404

Apr. 17, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients NCT02739100	Phase 1	Completed	Rockwell Medical Technologies, Inc.	13	2016-04 → 2016-07
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers NCT02767128	Phase 1	Completed	Rockwell Medical Technologies, Inc.	14	2016-04 → 2016-04
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients NCT04042324	Phase 1/2	Completed	Rockwell Medical Technologies, Inc.	12	2019-09-30 → 2020-01-16
Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire NCT01634945	N/A	Completed	Swiss Federal Institute of Technology	629	2012-04 → 2013-05
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients NCT03303144	Phase 1/2	Completed	Rockwell Medical Technologies, Inc.	27	2017-10-01 → 2017-12-28
The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate NCT02255942	N/A	Completed	Swiss Federal Institute of Technology	20	2015-04 → 2015-07
Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Trisodium Citrate and EDTA NCT02714075	N/A	Completed	Swiss Federal Institute of Technology	30	2016-04 → 2016-06
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis NCT01503021	Phase 3	Completed	Rockwell Medical Technologies, Inc.	718	2011-11 → 2014-01
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis NCT02909153	Phase 1	Completed	Rockwell Medical Technologies, Inc.	30	2017-01 → 2017-07
Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers NCT02636049	Phase 1	Completed	Rockwell Medical Technologies, Inc.	12	2015-10 → 2015-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2019	SUPPL -12	View Letter (PDF)
Apr 1, 2018	SUPPL -10	View Letter (PDF)
Oct 19, 2017	SUPPL -9	View Letter (PDF)
Jan 26, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 27.2MG IRON/5ML (5.44MG IRON/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jan 23, 2015

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7816404	Apr 17, 2029	—	—	Yes		—

#002 — 272MG IRON/50ML (5.44MG IRON/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 4, 2015