FERRIC PYROPHOSPHATE CITRATE - Generic Drug Details

What are the generic sources for ferric pyrophosphate citrate and what is the scope of patent protection?

Ferric pyrophosphate citrate is the generic ingredient in two branded drugs marketed by Rockwell Medical Inc and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric pyrophosphate citrate has thirteen patent family members in eleven countries.

Summary for FERRIC PYROPHOSPHATE CITRATE

International Patents:	13
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
What excipients (inactive ingredients) are in FERRIC PYROPHOSPHATE CITRATE?	FERRIC PYROPHOSPHATE CITRATE excipients list
DailyMed Link:	FERRIC PYROPHOSPHATE CITRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FERRIC PYROPHOSPHATE CITRATE

Dosage:

FOR SOLUTION;INTRAVENOUS

Dosage:

SOLUTION;INTRAVENOUS

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FERRIC PYROPHOSPHATE CITRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rockwell Medical Technologies, Inc.	Phase 3
Rockwell Medical Technologies, Inc.	Phase 2
Rockwell Medical Technologies, Inc.	Phase 1/Phase 2

See all FERRIC PYROPHOSPHATE CITRATE clinical trials

US Patents and Regulatory Information for FERRIC PYROPHOSPHATE CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	POWDER;INTRAVENOUS	208551-001	Apr 25, 2016		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015		DISCN	Yes	No			Y
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	POWDER;INTRAVENOUS	208551-001	Apr 25, 2016		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC AVNU	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	212860-001	Mar 27, 2020		DISCN	Yes	No				Y
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-002	Sep 4, 2015		DISCN	Yes	No

Expired US Patents for FERRIC PYROPHOSPHATE CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015

International Patents for FERRIC PYROPHOSPHATE CITRATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2016940	Procédés de préparation et utilisation de compositions chélatées de citrate et pyrophosphate ferrique (Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions)
Portugal	2016940
Slovenia	2016940
Canada	2638081	PROCEDES DE PREPARATION ET D'UTILISATION DE COMPOSITIONS CHELATEES DE CITRATE DE PYROPHOSPHATE FERRIQUE (METHODS FOR THE PREPARATION AND USE OF FERRIC PYROPHOSPHATE CITRATE CHELATE COMPOSITIONS)
Poland	2016940
Japan	2009108027	METHOD FOR PREPARATION AND USE OF FERRIC PYROPHOSPHATE CITRATE CHELATE COMPOSITION

FERRIC PYROPHOSPHATE CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ferric Pyrophosphate Citrate

Introduction

Ferric pyrophosphate citrate, known by its brand name Triferic, is a water-soluble iron salt used primarily to maintain iron balance and hemoglobin levels in patients undergoing hemodialysis. This article delves into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Size and Growth

The market for ferric pyrophosphate citrate is part of the broader intravenous iron drugs market, which was valued at USD 3.03 billion in 2023 and is expected to expand at a CAGR of 9.2% from 2024 to 2030[5].

Segmentation and Application

Ferric pyrophosphate citrate falls under the "Others" segment of the intravenous iron drugs market, which includes iron isomaltoside, ferric gluconate, and ferumoxytol. This segment is anticipated to grow at a rapid CAGR over the forecast period due to its increasing application in treating iron deficiency anemia, particularly in patients with chronic kidney disease (CKD)[5].

Key Applications

• Chronic Kidney Disease (CKD): Ferric pyrophosphate citrate is used to treat iron deficiency anemia in patients with CKD, both those on dialysis and those not on dialysis. It helps in regulating phosphorus levels and maintaining hemoglobin levels[3][4].
• Hemodialysis: Administered via dialysate, it maintains iron balance and hemoglobin levels in hemodialysis patients[4].

Drivers of Market Growth

Increasing Demand for Iron Supplements

The growing awareness and need for iron supplements, especially in the context of CKD and iron deficiency anemia, are significant drivers. Regulatory support for iron fortification and the increasing prevalence of CKD are also contributing factors[1][3].

Technological Advancements

Advancements in drug delivery methods, such as the administration of ferric pyrophosphate citrate via dialysate, have improved its efficacy and patient compliance. These technological advancements are expected to continue driving market growth[4].

Government Initiatives

Government initiatives to boost awareness about CKD and iron deficiency anemia are anticipated to increase the demand for ferric pyrophosphate citrate. These initiatives include educational campaigns and support for research and development in the field[3].

Restraints and Challenges

Side Effects

While ferric pyrophosphate citrate is generally well-tolerated, it can cause gastrointestinal side effects such as diarrhea and constipation. These side effects may deter some patients and healthcare providers from using the drug[2].

Cost Considerations

The cost of ferric pyrophosphate citrate is higher compared to some other iron supplements. However, economic analyses suggest that the reduction in erythropoiesis-stimulating agent (ESA) and intravenous iron requirements can result in net savings, making it a cost-effective option in the long run[2].

Competitive Landscape

The market for intravenous iron drugs, including ferric pyrophosphate citrate, is competitive with several key players such as Rockwell Medical, AMAG Pharmaceuticals, and Pharmacosmos. These companies are expanding their market footprint through geographical expansion and regulatory approvals[5].

Financial Trajectory

Revenue Projections

While specific revenue projections for ferric pyrophosphate citrate are not isolated, the broader intravenous iron drugs market is expected to grow significantly. The segment that includes ferric pyrophosphate citrate is anticipated to see rapid growth due to its efficacy and increasing application[5].

Geographical Performance

North America, particularly the U.S., accounts for a significant share of the intravenous iron drugs market due to the increasing approvals and launches of new IV drugs. Other regions, including Europe and Asia-Pacific, are also expected to contribute substantially to the market growth[5].

Pharmacokinetics and Safety

Ferric pyrophosphate citrate has been shown to be rapidly bound to transferrin and cleared from the circulation without increasing serum hepcidin levels or biomarkers of oxidative stress or inflammation. This pharmacokinetic profile supports its safety and efficacy in clinical use[4].

Key Takeaways

• Growing Demand: Increasing demand for iron supplements, especially in CKD patients, drives the market.
• Technological Advancements: Improved drug delivery methods enhance efficacy and compliance.
• Regulatory Support: Government initiatives and regulatory support for iron fortification boost market growth.
• Competitive Landscape: The market is competitive, with key players expanding their geographical presence.
• Financial Projections: The broader intravenous iron drugs market is expected to grow significantly, with the segment including ferric pyrophosphate citrate seeing rapid growth.

FAQs

What is ferric pyrophosphate citrate used for?

Ferric pyrophosphate citrate is used to maintain iron balance and hemoglobin levels in patients undergoing hemodialysis and to treat iron deficiency anemia in patients with chronic kidney disease.

How is ferric pyrophosphate citrate administered?

It is administered via dialysate to patients undergoing hemodialysis.

What are the key drivers of the market growth for ferric pyrophosphate citrate?

The key drivers include increasing demand for iron supplements, technological advancements, and government initiatives to boost awareness about CKD and iron deficiency anemia.

What are the potential side effects of ferric pyrophosphate citrate?

Potential side effects include gastrointestinal issues such as diarrhea and constipation.

How does the cost of ferric pyrophosphate citrate compare to other iron supplements?

While the initial cost is higher, it can result in net savings due to reduced requirements for erythropoiesis-stimulating agents (ESAs) and intravenous iron.

Cited Sources:

1. Market Research Intellect - Ferric Pyrophosphate Market Size, Growth & Analysis Report 2024
2. ScholarWorks - Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD
3. Fior Markets - Ferric Citrate Market Size, Growth & Industry Manufacturer 2032
4. PubMed - Pharmacokinetics of Ferric Pyrophosphate Citrate, a Novel Iron Salt
5. Grand View Research - Intravenous Iron Drugs Market Size And Share Report, 2030