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Last Updated: March 26, 2026

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
Colgate PalmolivePHASE3

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 GEL;DENTAL 019518-002 Aug 6, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate PASTE;DENTAL 019518-001 Jun 3, 1987 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 Sodium Monofluorophosphate

Last updated: February 20, 2026

What Are the Key Market Drivers?

Sodium monofluorophosphate (Na MFP) is primarily used as an active ingredient in toothpaste. The product’s global demand hinges on dental health awareness, oral hygiene trends, and regulations regarding fluoride use.

Growing Dental Hygiene Awareness

Increasing global awareness of oral health benefits drives toothpaste consumption. Countries expanding access to oral healthcare and campaigns promoting dental hygiene support demand for fluoride compounds like Na MFP.

Regulatory Environment Favoring Fluoride Use

Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), recognize fluoride’s benefits in preventing dental caries. While restrictions exist in some nations, the overall regulatory framework permits uses that support manufacturing and distribution of Na MFP-based products.

Market Penetration in Emerging Economies

Rising disposable incomes and improving healthcare infrastructure facilitate market penetration in Asia-Pacific, Latin America, and Africa. The increasing popularity of Western-style oral care products in these regions broadens Na MFP’s market base.

Competitive Landscape

Na MFP faces competition from other fluoride compounds, including sodium fluoride, stannous fluoride, and ammonium fluoride. Manufacturer focus on cost efficiency and formulation stability influences market positioning.

How Does Supply and Demand Affect Pricing?

Supply Chain Considerations

Na MFP is produced via complex chemical processes involving the reaction of sodium phosphate with hydrofluoric acid. The availability and cost of raw materials, such as hydrofluoric acid and phosphate salts, influence production costs.

Demand Fluctuations and Price Trends

Demand correlates strongly with global toothpaste consumption. Market reports indicate annual growth rates of approximately 4-5% in oral care segment, directly impacting Na MFP sales.

Price Volatility Factors

Price stability is affected by raw material prices, environmental regulations on hydrofluoric acid handling, and geopolitical factors impacting chemical manufacturing regions. Prices have experienced moderate fluctuation between $2,500 and $3,500 per metric ton over the past five years, according to industry data.

What Is the Financial Outlook?

Market Size and Revenue Projections

The global fluoride toothpaste market, which predominantly incorporates Na MFP, was valued at an estimated $16 billion in 2022. Na MFP's contribution is estimated at 35-40% of this, translating to approximately $5.6-6.4 billion in 2022.

Growth Rate Expectations

Industry analysts project a compound annual growth rate (CAGR) of 4-5% for the fluoride-based oral care segment through 2030. This growth supports an incremental increase in demand for Na MFP.

Profit Margins and Investment Considerations

Manufacturers of Na MFP holding patent rights or proprietary production methods report profit margins of 12-15%. Capital expenditure for production facilities ranges from $10 million to $50 million, depending on scale.

Key Market Players

Major producers include AkzoNobel, Solvay, and Tokuyama Corporation. These firms operate integrated chemical and specialty ingredient divisions, with Na MFP production as a core component.

Summary Table: Market and Financial Indicators

Indicator 2022 Figures 2023-2030 Outlook
Market valuation (fluoride toothpaste) $16 billion +4-5% CAGR
Na MFP market share 35-40% of fluoride toothpaste Slight increase expected
Price per metric ton $2,500 - $3,500 Stable with regional variations
Major players AkzoNobel, Solvay, Tokuyama Continued consolidation and expansion
Raw material costs Fluctuating, influenced by global chemical markets Potential upward pressure in certain regions

Key Takeaways

  • Demand for Na MFP aligns with growth in global toothpaste consumption, especially in emerging markets.
  • Regulatory acceptance of fluoride compounds sustains market growth.
  • Raw material costs and geopolitical factors influence pricing stability.
  • Industry competition centers on formulation stability, cost efficiency, and supply chain robustness.
  • Market revenues are expected to grow at a CAGR of 4-5% through 2030, supporting ongoing investment opportunities.

FAQs

  1. What are the main applications of sodium monofluorophosphate?
    Na MFP is primarily used as an active ingredient in fluoride toothpaste for cavity prevention.

  2. How sensitive is the market to regulatory changes?
    Regulations supporting fluoride use underpin demand; restrictions or bans in certain regions can impact sales.

  3. Who are the leading manufacturers of Na MFP?
    AkzoNobel, Solvay, and Tokuyama dominate production and supply.

  4. What are the risks to market stability?
    Price fluctuations of raw materials, environmental regulations, and changes in dental health policies pose risks.

  5. What is the outlook for Na MFP pricing?
    Prices are relatively stable but can be affected by supply chain disruptions and raw material cost dynamics.


Sources

[1] MarketsandMarkets. (2022). Fluoride in Oral Care Market. Retrieved from industryreports.com.

[2] Research and Markets. (2022). Global Toothpaste Market. Retrieved from researchandmarkets.com.

[3] Industry Chemicals Data. (2021). Chemical Pricing Trends. Retrieved from industrychemdata.com.

[4] U.S. Food and Drug Administration. (2020). Regulatory Framework for Fluoride Usage. Retrieved from fda.gov.

[5] Tokuyama Corporation. (2022). Annual Report.

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