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Last Updated: March 26, 2026

Ferrous sulfate; folic acid - Generic Drug Details


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What are the generic sources for ferrous sulfate; folic acid and what is the scope of freedom to operate?

Ferrous sulfate; folic acid is the generic ingredient in one branded drug marketed by Lederle and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ferrous sulfate; folic acid
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 91
DailyMed Link:ferrous sulfate; folic acid at DailyMed
Recent Clinical Trials for ferrous sulfate; folic acid

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

SponsorPhase
Hull University Teaching Hospitals NHS TrustPHASE3
Pharmacosmos Therapeutics, Inc.PHASE3
Istanbul University - CerrahpasaNA

See all ferrous sulfate; folic acid clinical trials

US Patents and Regulatory Information for ferrous sulfate; folic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle FOLVRON ferrous sulfate; folic acid CAPSULE;ORAL 006012-003 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 Ferrous Sulfate and Folic Acid

Last updated: February 15, 2026

Market Overview

Ferrous sulfate and folic acid are critical iron and vitamin supplements, respectively. Both are foundational in treating nutritional deficiencies, with applications spanning anemia management, prenatal care, and general health supplementation. The combined market size for these drugs is projected to grow, driven by demographic shifts, healthcare access expansion, and increasing awareness of deficiency-related conditions.

Market Size and Growth Projections

In 2022, the global iron supplements market, primarily driven by ferrous sulfate, was valued at approximately USD 2.3 billion. The folic acid segment, driven by prenatal and pediatric indications, held an estimated USD 1.2 billion. The compounded annual growth rate (CAGR) for the combined market is forecasted at 4.5% from 2023 to 2030.

This growth aligns with rising prevalence of anemia—estimated to affect 1.62 billion people worldwide—alongside increased preconception health initiatives promoting folic acid supplementation.

Key Market Drivers

  • Aging Population: Elderly individuals experience higher anemia rates, increasing demand for ferrous sulfate.
  • prenatal and maternal health programs: Folic acid intake is mandated by health agencies globally, expanding its market.
  • Nutritional deficiency awareness: Public health campaigns regarding iron and folic acid deficiencies support demand.
  • Regulatory policies: Fortification mandates, such as iron-fortified foods, indirectly influence supplement sales.
  • Developing markets: Countries in Asia and Africa show rapid growth owing to increased healthcare infrastructure.

Market Segments and Pricing

Ferrous sulfate is predominantly manufactured in tablet, capsule, and liquid forms with prices ranging from USD 0.05 to 0.20 per tablet, depending on formulation and region. Folic acid is commonly available as over-the-counter supplements, with prices from USD 0.10 to 0.50 per dose.

In branded markets, the average retail price for ferrous sulfate ranges between USD 3 to 10 per bottle (60-100 tablets), while folic acid supplements retail at USD 5 to 15 per month’s supply.

Competition Landscape

Major manufacturers include Bayer, Mylan, Teva, and Sun Pharma, with extensive portfolios of generic and branded formulations. The market is highly commoditized, with generic versions dominating due to low barriers to entry.

Recent patent expirations for key formulations have increased generic penetration, leading to price erosion and pressure on profit margins for branded products.

Regulatory Environment

Regulation influences market access and formulation standards. The FDA classifies ferrous sulfate and folic acid as generally recognized as safe (GRAS), facilitating OTC availability. Some nations enforce mandatory fortification policies, directly impacting demand.

Regulatory slowdowns or changes in approval processes for new formulations can temporarily hinder market growth.

Financial Trajectory and Investment Trends

Companies focusing on generic production experience steady, predictable revenue streams. Innovation in delivery systems—such as sustained-release formulations or combination products—can command premium pricing and higher margins.

Biotech companies exploring novel iron delivery methods or bioavailable folic acid derivatives have attracted venture funding, anticipating clinical breakthroughs. The sector’s capital investments are moderate and stable, reflecting low R&D costs compared to proprietary pharmaceuticals.

Risks and Challenges

  • Price Competition: Widespread availability of generics compresses margins.
  • Regulatory Changes: Stricter regulations on supplement claims or fortification can alter market dynamics.
  • Supply Chain Disruptions: Raw material shortages, especially of ferrous sulfate, can constrain supply.
  • Consumer Preference: Shift towards natural or plant-based sources may influence supplement formulations.

Emerging Opportunities

  • Developing combination products targeting iron deficiency anemia and prenatal health.
  • Entering emerging markets where unmet needs persist.
  • Innovating with alternative delivery mechanisms to improve compliance.

Key Takeaways

  • The combined market for ferrous sulfate and folic acid is expanding at around 4.5% CAGR, driven by demographic trends, health awareness, and regulatory policies.
  • Generic formulations dominate due to low entry barriers, exerting downward pressure on prices.
  • The market's stability relies on consistent supply chains, regulatory compliance, and strategic adaptation to evolving consumer preferences.
  • Differentiated products and entry into emerging markets present growth opportunities.
  • R&D investments are generally modest, focusing on formulation innovation rather than active ingredient development.

FAQs

  1. How does the aging population influence the ferrous sulfate market?
    It increases demand for anemia treatments, boosting sales of ferrous sulfate supplements among older adults.

  2. What regulatory policies impact the folic acid market globally?
    Many countries mandate folic acid fortification to prevent neural tube defects, expanding market demand.

  3. Are there patent protections for ferrous sulfate or folic acid formulations?
    Most formulations are off-patent, mainly available as generics, leading to intense price competition.

  4. What are the main challenges faced by manufacturers?
    Price competition, raw material volatility, regulatory shifts, and supply chain risks.

  5. What future innovations could alter market dynamics?
    Novel delivery systems, combination products, and bioavailable derivatives designed to improve absorption and compliance.

Sources

  1. MarketWatch, 2023. "Global Iron Supplements Market Size."
  2. Deloitte, 2022. "Nutritional Supplements Industry Report."
  3. World Health Organization, 2021. "Global Anemia Burden."
  4. Global Data, 2023. "Pharmaceutical Market Outlook."
  5. FDA, 2022. "Guidance on Dietary Supplement Regulation."

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