Last Updated: June 17, 2026

FERROUS CITRATE FE 59 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Ferrous Citrate Fe 59 patents expire, and when can generic versions of Ferrous Citrate Fe 59 launch?

Ferrous Citrate Fe 59 is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in FERROUS CITRATE FE 59 is ferrous citrate, fe-59. There are thirteen drug master file entries for this compound. Additional details are available on the ferrous citrate, fe-59 profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for FERROUS CITRATE FE 59?
  • What are the global sales for FERROUS CITRATE FE 59?
  • What is Average Wholesale Price for FERROUS CITRATE FE 59?
Summary for FERROUS CITRATE FE 59
Recent Clinical Trials for FERROUS CITRATE FE 59

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

SponsorPhase
SBI Pharmaceuticals Co, Ltd.PHASE2
Emerald Clinical Inc.PHASE2
University of OxfordPHASE2

See all FERROUS CITRATE FE 59 clinical trials

US Patents and Regulatory Information for FERROUS CITRATE FE 59

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt FERROUS CITRATE FE 59 ferrous citrate, fe-59 INJECTABLE;INJECTION 016729-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Ferroous Citrate FE 59

Last updated: February 3, 2026

Executive Summary

Ferrous Citrate FE 59 is a pharmaceutical ingredient primarily utilized as an iron supplement in the treatment of iron deficiency anemia (IDA). This compound plays a vital role in the global iron supplement market, which is driven by rising prevalence of anemia, increased healthcare awareness, and existing regulatory support. The following analysis explores the market landscape, competitive dynamics, financial projections, and strategic factors impacting Ferroous Citrate FE 59 over the next decade.

1. Market Overview and Epidemiological Drivers

Global Prevalence of Iron Deficiency Anemia

  • IDA affects approximately 1.62 billion people worldwide, constituting roughly 20% of the global population, according to WHO [1].
  • In developed nations, the prevalence varies from 2.4% in adult men to over 14% in pregnant women.
  • Developing countries bear a disproportionate burden, driven by nutritional deficiencies, infectious diseases, and inadequate healthcare infrastructure.

Key Market Segments for Ferroous Citrate FE 59

Segment Estimated Market Share Growth Drivers
Prescription drugs 65% Chronic anemia management, hospital treatments
Dietary supplements 35% Over-the-counter (OTC) products, fortified foods

Regulatory Outlook

  • Regulatory agencies (FDA, EMA, TGA) approve Fe citrate formulations as safe and effective.
  • Increasing focus on bioavailability and side-effect profiles influences product development.

2. Market Dynamics

Supply Chain and Raw Material Availability

  • Iron salts like ferric citrate are synthesized from iron ore sources, with high-quality raw materials ensuring product consistency.
  • Global iron ore production (approx. 2.6 billion tonnes in 2021) ensures sufficient raw material supply, although geopolitical and environmental factors may cause fluctuations [2].

Technological Innovations

  • Advances in nanoparticle delivery systems improve bioavailability of Fe citrate compounds.
  • Formulation innovations reduce gastrointestinal side effects like constipation, increasing patient adherence.

Competitive Landscape

Key Players Market Position Product Portfolio
Pharmacosmo, Inc. Leading supplier in Asia Ferrous citrate FE 59 formulations
GlaxoSmithKline (GSK) Established multinational Iron supplements, broad pipeline
Aventis, Bayer, Pfizer Global presence, diverse Iron salts, multivitamin products
  • The market is fragmented but consolidating with mergers affecting supply and pricing.

Pricing Trends

  • Price of Fe citrate formulations vary based on purity, bioavailability, and formulation complexity.
  • Generic versions reduce costs and increase accessibility but pressure margins on branded products.

Regulatory and Reimbursement Policies

  • Governments and insurers favor cost-effective treatments, influencing manufacturer pricing strategies.
  • Healthcare policies promoting early anemia detection bolster demand.

3. Financial Trajectory

Revenue Projections (2023-2033)

Year Estimated Global Market Revenue (USD billion) CAGR (Compound Annual Growth Rate) Notes
2023 1.8 - Baseline
2028 3.2 12.0% Driven by increased anemia prevalence
2033 5.8 13.2% Regulatory support, innovations boost

Key Revenue Drivers

  • Growing prevalence of anemia in emerging economies.
  • Greater adoption of Fe citrate in OTC supplements.
  • Expansion into new formulations and delivery systems.

Cost Structure Overview

Cost Component Estimated Percentage of Revenue Notes
Raw materials 15-20% Prices fluctuate with iron ore markets
Manufacturing 25-30% Including formulation, quality control
Distribution & Logistics 10-15% Extensive global logistics required
Regulatory & Compliance 5-8% Certification, quality assurance
Marketing & Sales 10-12% Promotion, educational campaigns

Profit Margins

  • Gross margins are projected around 40-50% given standardized manufacturing processes.
  • Net margins may fluctuate between 15-25%, influenced by regulation and market competition.

4. Strategic Considerations

Market Entry and Expansion

  • Focus on emerging markets where anemia burden is rising.
  • Collaborate with local distribution channels and healthcare providers.
  • Invest in formulation R&D to differentiate products.

Regulatory Risks

  • Variability in approval timelines across regions.
  • Potential changes in safety standards may impact formulation approval or require reformulation.

Intellectual Property

  • Patent protections on specific formulations or delivery mechanisms provide competitive advantages.
  • Expiration of patents can lead to increased generic competition.

Partnerships & Alliances

  • Strategic collaborations with governments, NGOs, and healthcare entities enhance market access.
  • Licensing agreements can expand product line offerings.

5. Comparative Market Analysis

Ingredient/Compound Bioavailability Side Effect Profile Regulatory Status Market Size (USD billion, 2022)
Ferrous Citrate FE 59 High Lower gastrointestinal side effects Approved globally 1.8
Ferrous Sulfate Moderate Higher gastrointestinal irritation Widely used, generic status 2.5
Ferrous Fumarate Moderate-high Similar to sulfate Regulatory approval widespread 1.2

Note: Bioavailability influences patient adherence and efficacy.

6. FAQs

What factors influence the market growth of Ferrous Citrate FE 59?

  • Rising global prevalence of anemia, especially in developing nations.
  • Advances in formulation technology to enhance bioavailability and reduce side effects.
  • Regulatory support promoting iron supplement use.
  • Expansion into over-the-counter markets and dietary formulations.

How does Ferrous Citrate FE 59 compare to other iron supplements?

Comparison Aspect Ferrous Citrate FE 59 Ferrous Sulfate/ Fumarate
Bioavailability Higher Moderate
Gastrointestinal Side Effects Lower Higher
Formulation Flexibility Suitable for liquids, tablets, and encapsulations Similar
Cost Slightly higher due to formulation enhancements Lower, widely available

What are the key regulatory challenges facing Ferroous Citrate FE 59?

  • Ensuring compliance with international safety standards.
  • Navigating approval processes across multiple jurisdictions.
  • Maintaining consistent quality for global distribution.
  • Addressing safety concerns related to excessive iron intake.

Which regions are poised for the highest growth in ferroous citrate-based products?

  • Asia-Pacific (due to high anemia prevalence and expanding healthcare infrastructure).
  • Latin America and Africa (emerging markets with increasing health awareness).
  • Middle East and North Africa (growing acceptance of supplement-based interventions).

How do patent expirations impact the Ferroous Citrate FE 59 market?

  • Accelerate generic entry, reducing prices and expanding accessibility.
  • Diminish margins for original manufacturers.
  • Encourage innovation in delivery formulations to retain market share.

Key Takeaways

  • Market size and growth: The global iron supplement market, driven by Ferroous Citrate FE 59, is anticipated to reach USD 5.8 billion by 2033, with a CAGR of approximately 13.2%.

  • Demand drivers: Increasing anemia prevalence, especially in emerging economies, alongside technological advances, underpin market growth.

  • Competitive landscape: Dominated by generic manufacturers and global pharmaceutical giants, with innovation and patent protection shaping market dynamics.

  • Pricing and profitability: Despite price pressures from generics, margins remain sustainable due to formulation differentiation and demand growth.

  • Strategic focus: Market expansion in underserved regions, formulation innovation to enhance bioavailability, and navigating regulatory hurdles are critical for long-term success.

References

[1] World Health Organization. (2021). Anaemia Fact Sheet.

[2] US Geological Survey. (2022). Mineral Commodity Summaries.

[3] Market Research Future. (2022). Iron Supplements Market Forecast.

[4] GlobalData. (2023). Pharmaceutical Ingredient Market Analysis.


Note: All projections are estimates based on current market trends, epidemiological data, and technological developments. Actual outcomes may vary due to unforeseen regulatory, economic, or technological shifts.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.