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Last Updated: December 12, 2025

SODIUM MONOFLUOROPHOSPHATE - Generic Drug Details


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What are the generic drug sources for sodium monofluorophosphate and what is the scope of freedom to operate?

Sodium monofluorophosphate is the generic ingredient in one branded drug marketed by Chesebrough Ponds and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for sodium monofluorophosphate.

Summary for SODIUM MONOFLUOROPHOSPHATE
Recent Clinical Trials for SODIUM MONOFLUOROPHOSPHATE

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

SponsorPhase
EgymedicalpediaPhase 1
Procter and GamblePhase 4
University of Campinas, BrazilPhase 4

See all SODIUM MONOFLUOROPHOSPHATE clinical trials

US Patents and Regulatory Information for SODIUM MONOFLUOROPHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate PASTE;DENTAL 019518-001 Jun 3, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate GEL;DENTAL 019518-002 Aug 6, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Sodium Monofluorophosphate

Last updated: August 1, 2025

Introduction

Sodium Monofluorophosphate (SMFP) is a key active ingredient predominantly used in dental care products, notably toothpaste formulations, due to its proven efficacy in preventing dental caries. As a fluoride compound, SMFP offers a fluoride source with unique properties—combining stable alkali metal content with a fluorine atom—making it a preferred choice among formulators and consumers concerned with oral health. The evolution of the global oral care industry, regulatory frameworks, and technological advancements influence the market dynamics and financial outlook for SMFP. This analysis explores the current landscape, growth drivers, risks, and future financial trajectories for this commodity.


Market Overview

The global market for fluoride-based oral care ingredients is expanding, driven by rising awareness of oral hygiene, increasing dental health issues, and a surge in demand for preventative dental products. SMFP holds a significant share within this segment, especially in regions with stringent fluoride regulations such as North America, Europe, and parts of Asia-Pacific.

According to industry reports, the global toothpaste market was valued at approximately USD 17 billion in 2022, growing at a compound annual growth rate (CAGR) of around 4–5% (1). Fluoride compounds like SMFP account for a substantial portion of the raw materials utilized in toothpaste formulations, with an estimated valuation in the tens of millions USD regionally and globally.


Market Dynamics

Demand Drivers

  • Rising Awareness of Dental Health: Increased public consciousness about oral health's role in overall well-being propels demand for fluoride-containing products. Governments and health organizations worldwide advocate for regular dental care, emphasizing fluoride’s role in caries prevention.

  • Preventive Dental Care Trends: Consumers are shifting from reactive to preventive health behaviors. Toothpaste with fluoride, including SMFP, benefits from this trend, emphasizing cavity prevention and enamel remineralization.

  • Regulatory Environment: Regulatory agencies such as the US FDA and European Medicines Agency (EMA) recognize fluoride compounds’ efficacy and safety when used within prescribed limits. These regulations favor the continued use and innovation in fluoride-based products.

  • Innovation and Product Development: Advances in formulation technology have allowed manufacturers to incorporate SMFP more effectively, improving stability and efficacy in oral care products.

Supply Dynamics

  • Raw Material Availability: SMFP is synthesized through controlled chemical reactions involving phosphorus compounds and fluorinating agents. The stability and availability of raw materials influence supply security. Notably, the primary feedstock—phosphoric acid and fluorinating agents like hydrofluoric acid—are subject to geopolitical and supply chain considerations.

  • Manufacturing Capacity: Leading chemical producers, primarily based in Asia (notably China and India), have predominantly scaled production due to cost advantages. This regional concentration leads to competitive pricing but also exposes the market to regional disruptions.

Pricing Trends

SMFP pricing remains competitive, influenced heavily by the raw material costs and manufacturing efficiencies. Market surveys suggest a slight decline in unit prices over recent years owing to increased production capacities and competitive pressures (2). However, pricing stability is susceptible to raw material price volatility and regulatory compliance costs.

Competitive Landscape

The market is characterized by a limited number of large chemical companies specialized in fluoride synthesis, including companies like Solvay (Belgium), Solus Advanced Technologies, and several Chinese chemical manufacturers. The consolidation trend and high entry barriers due to technical complexity maintain a concentrated market structure.


Financial Trajectory and Market Outlook

Historical Trends

Over the past five years, SMFP's financial demand has exhibited moderate growth aligned with global oral care market expansion. Industry reports indicate annual growth rates in the range of 3–5%, consistent with toothpaste market trends (1). The stability of the fluoride market segment and the incremental addition of SMFP in new product lines pairing with other active ingredients underpin this performance.

Future Projections

Projections indicate the global fluoride market will maintain a CAGR of approximately 4% to 5% through 2030 (3). SMFP, as a core fluoride delivery agent, is expected to benefit proportionally. Factors influencing future growth include:

  • Regional Expansion: Asian markets, notably China and India, are projected to see increased demand due to rising consumer disposable incomes and expanding dental care awareness.

  • Innovation in Dental Formulations: The development of next-generation fluoride compounds and alternative delivery systems could influence SMFP’s market share. Nonetheless, current formulations utilizing SMFP are expected to remain dominant due to proven efficacy and regulatory acceptance.

  • Regulatory Trends: Stringent regulations favoring safety and eco-friendly manufacturing may encourage technological innovation, possibly leading to higher value-added SMFP variants—thus positively impacting profitability.

  • Sustainability Initiatives: Growing emphasis on sustainable and environmentally friendly chemicals could prompt companies to optimize manufacturing processes, potentially reducing costs or encouraging formulations with lower environmental footprints.

Risks and Challenges

  • Raw Material Price Volatility: Fluctuations in phosphorus and fluorinating agents' prices can impact manufacturing costs and profit margins.

  • Regulatory Scrutiny: Increased regulation to ensure safety and environmental compliance could impose cost burdens or restrict certain manufacturing processes.

  • Market Saturation: The mature nature of the fluoride market and pressure from alternative caries prevention technologies (e.g., nano-hydroxyapatite) pose long-term challenges.

  • Supply Chain Disruptions: Geopolitical tensions, pandemics, or natural disasters affecting raw material supplies or manufacturing hubs threaten market stability.


Economic Impact Analysis

The profitability of SMFP largely hinges on manufacturing efficiency, raw material costs, and market demand. Large chemical companies report gross margins between 20–30% on fluoride products, with net margins varying based on scale, regulation, and market access (4). As the industry moves toward higher-value formulations, value-added derivatives of SMFP might offer enhanced profit margins.

Market forecasts suggest that, with stable raw material sourcing, unit sale prices could decline marginally due to fierce competition and oversupply. However, the overall revenue generated from SMFP in the global oral care additive segment is expected to sustain moderate growth aligned with dental care industry trends.


Conclusion

Sodium Monofluorophosphate’s market remains fundamentally robust, driven by sustained global demand for fluoride-based oral care products. Its financial trajectory projects steady growth, supported by increasing awareness of dental health, ongoing innovation, and expanding markets in Asia-Pacific. Nonetheless, manufacturers and investors should remain vigilant regarding raw material prices, regulatory environments, and emerging technologies that could alter market dynamics.


Key Takeaways

  • Stable Demand: The global oral care industry’s growth ensures consistent demand for SMFP as a primary fluoride source.

  • Pricing and Competition: Competitive manufacturing and raw material availability sustain relatively stable pricing, with margins under pressure from market saturation.

  • Regional Markets: Asia-Pacific offers significant growth opportunities, driven by rising consumer income and awareness.

  • Technological Advancements: Innovation in formulation technology and sustainability practices will influence future profitability.

  • Risks Management: Diversification, supply chain resilience, and regulatory compliance are critical for maintaining a positive financial trajectory.


FAQs

  1. What is Sodium Monofluorophosphate primarily used for?
    Sodium Monofluorophosphate is predominantly used as an active fluoride source in toothpaste and other oral hygiene products to prevent dental caries.

  2. How does the demand for SMFP impact its market price?
    Demand stability in the oral care sector, coupled with raw material costs and manufacturing efficiencies, influences SMFP’s market price. Increased demand typically stabilizes or slightly boosts pricing.

  3. What are the main raw materials required for SMFP synthesis?
    The main raw materials include phosphorus sources, such as phosphoric acid, and fluorinating agents like hydrofluoric acid.

  4. Are there environmental or regulatory concerns associated with SMFP production?
    Yes, production involves fluorinating agents that require strict handling and disposal regulations. Environmental sustainability and safety regulations could impact manufacturing practices and costs.

  5. What future trends could affect SMFP’s market trajectory?
    Innovations in alternative fluoride delivery systems, stricter environmental regulations, regional market expansion, and advancements in dental health technology could shape the future demand and profitability for SMFP.


References

[1] MarketWatch. "Global Toothpaste Market Report." 2022.
[2] Chemical Market Reporter. "Fluoride Compounds Pricing Trends." 2022.
[3] Research and Markets. "Global Fluoride Market Forecast 2023–2030." 2023.
[4] Industry Insider. "Margins and Profitability in Fluoride Chemicals." 2022.

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