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Last Updated: April 4, 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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate PASTE;DENTAL 019518-001 Jun 3, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate GEL;DENTAL 019518-002 Aug 6, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Sodium Monofluorophosphate Market Dynamics and Financial Trajectory

Introduction

Sodium monofluorophosphate (MFP), a compound with the chemical formula Na₂PO₃F, is widely used as an active pharmaceutical ingredient (API) in various applications, particularly in dental care products. Here, we delve into the market dynamics and financial trajectory of sodium monofluorophosphate, highlighting key trends, drivers, and challenges.

Market Segmentation

The sodium monofluorophosphate market is segmented based on product type, end-users, and geographical regions.

By Product Type

  • Industrial Grade: Used in various industrial applications such as water treatment and manufacturing processes.
  • Toothpaste Grade: The most common application, where MFP is used as an anti-caries agent in toothpastes and mouth rinses[2].
  • Other Product Types: Includes pharmaceutical and cosmetic applications.

By End Users

  • Industrial Application: Water treatment, manufacturing processes, and other industrial uses.
  • Toothpaste: The primary end-user, where MFP is used to prevent dental caries.
  • Pharmaceutical: Used in other pharmaceutical products.
  • Cosmetics: Used in various cosmetic products for its fluoride content[1].

By Region

  • North America: The United States and Canada are significant markets, driven by the demand for water treatment chemicals and dental care products.
  • Europe: Germany, France, and Italy are key markets, with a strong presence of end-use industries.
  • Asia Pacific: China, India, and Japan are the largest markets, driven by rapid industrialization and urbanization.
  • Latin America: Expected to be a significant market due to growing demand.
  • Middle East & Africa: Witnessing moderate growth due to the presence of undeveloped countries[1].

Market Size and Growth

The global sodium monofluorophosphate market is valued at a significant amount, although exact figures are not provided. However, it is projected to grow at a substantial CAGR over the forecast period from 2023 to 2030.

Revenue and CAGR

  • The market is expected to grow at a CAGR of around 4-5% during the forecast period, driven by increasing demand from various industries[1][4].

Regional Growth

  • Asia Pacific: This region is expected to be the fastest-growing market, driven by rapid industrialization and urbanization in countries like China and India. The region is anticipated to grow at a CAGR of 5.1% during the forecast period[1].
  • North America: Expected to grow at a CAGR of 4.8%, driven by the growing demand for water treatment chemicals and dental care products[1].
  • Europe: Expected to grow at a CAGR of 3.9%, driven by the presence of a large number of end-use industries[1].

Drivers of Market Growth

Several factors are driving the growth of the sodium monofluorophosphate market:

Increasing Demand for Dental Care Products

  • The rise in oral health awareness and the increasing prevalence of oral diseases globally are driving the demand for MFP in toothpastes and mouth rinses[3].

Industrial Applications

  • MFP is used in various industrial applications such as water treatment, which is a significant driver for market growth[1].

Government Initiatives

  • Community water fluoridation programs and other government initiatives aimed at improving oral health are boosting the demand for MFP[3].

Challenges and Constraints

Despite the growth, the market faces several challenges:

Volatile Raw Material Prices

  • The price of phosphate rock, a key raw material for MFP, has been volatile, affecting the production costs. China's reduction in phosphate rock exports has further exacerbated this issue[1].

Transportation Costs

  • Long-distance transportation costs from production centers in China and India to demand centers in the U.S. and Europe add to the overall cost of MFP[1].

Alternative Products

  • The increased cost of MFP has led some consumers to switch to alternative products, putting downward pressure on prices[1].

Competitive Landscape

The global sodium monofluorophosphate market is competitive, with several key players:

Major Players

  • Top Pharm Chemical Group
  • Hubei Xingfa Chemicals Group
  • Wuxi Ruiyuan Chemical
  • Tianjin Changlu Huaxin
  • Sichuan Chenghong Phosph-Chemical
  • Suzhou YingKe Biotech
  • Suzhou Yotech Fine Chemical
  • Sulux Phosphates[1].

Recent Advancements

There have been significant advancements in the sodium monofluorophosphate market:

Modernization of Monographs

  • The United States Pharmacopeia (USP) has initiated a global effort to modernize the monographs for MFP, including the adoption of ion chromatography (IC) methods for quality and stability assessments[2].

Quality Improvement

  • The quality of MFP has been improving, making it a more attractive option for buyers. Suppliers are also offering MFP in bulk quantities, making it more affordable[1].

Financial Impact

The financial trajectory of the sodium monofluorophosphate market is influenced by several factors:

Cost of Production

  • The rising cost of raw materials and transportation has increased the cost of production, which is passed on to consumers in the form of higher prices for products containing MFP[1].

Return on Investment

  • Studies have shown that every $1 invested in water fluoridation saves $38 in dental treatment costs, indicating a positive return on investment for MFP in dental care applications[1].

Regional Market Insights

Asia Pacific

  • This region is expected to drive the market growth due to rapid industrialization and urbanization in countries like China and India. The burgeoning steel industry and increased healthcare expenditure are also contributing factors[3].

North America and Europe

  • These regions are expected to grow at a moderate pace, driven by the demand for water treatment chemicals and dental care products. Germany, France, and Italy are significant markets in Europe[1].

Conclusion

The sodium monofluorophosphate market is poised for significant growth driven by increasing demand from dental care and industrial applications. However, the market faces challenges such as volatile raw material prices and transportation costs. Key players are focusing on improving the quality of MFP and offering it in bulk quantities to make it more affordable.

Key Takeaways

  • The global sodium monofluorophosphate market is growing due to increasing demand from dental care and industrial applications.
  • Asia Pacific is the fastest-growing region, driven by rapid industrialization and urbanization.
  • Volatile raw material prices and transportation costs are significant challenges.
  • Key players are improving the quality of MFP and offering it in bulk quantities.
  • Government initiatives and community water fluoridation programs are driving the demand for MFP.

FAQs

What is the primary use of sodium monofluorophosphate?

Sodium monofluorophosphate is primarily used as an anti-caries agent in toothpastes and mouth rinses.

Which region is expected to be the fastest-growing market for sodium monofluorophosphate?

The Asia Pacific region is expected to be the fastest-growing market, driven by rapid industrialization and urbanization in countries like China and India.

What are the key challenges facing the sodium monofluorophosphate market?

The key challenges include volatile raw material prices, transportation costs, and the switch to alternative products due to increased costs.

Who are the major players in the sodium monofluorophosphate market?

Major players include Top Pharm Chemical Group, Hubei Xingfa Chemicals Group, Wuxi Ruiyuan Chemical, and others.

How does the cost of production affect the market?

The rising cost of raw materials and transportation has increased the cost of production, which is passed on to consumers in the form of higher prices for products containing MFP.

Sources

  1. Vantage Market Research, Sodium Monofluorophosphate Market - Global Industry Assessment & Forecast.
  2. Labrulez, Sodium monofluorophosphate monograph modernization.
  3. GlobeNewswire, Global Sodium Fluoride Market Projected to Reach US$915.781 Million by 2029.
  4. Maximize Market Research, Sodium Fluoride Market - Industry Analysis And Forecast.

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