You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Monobasic Sodium Phosphate And Dibasic Sodium Phosphate, and when can generic versions of Monobasic Sodium Phosphate And Dibasic Sodium Phosphate launch?

Monobasic Sodium Phosphate And Dibasic Sodium Phosphate is a drug marketed by Novel Labs Inc and is included in one NDA.

The generic ingredient in MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE?
  • What are the global sales for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE?
  • What is Average Wholesale Price for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE?
Summary for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE at DailyMed
Drug patent expirations by year for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
Pharmacology for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

US Patents and Regulatory Information for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 079247-001 Dec 30, 2011 RX No Yes ⤷  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 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate

Last updated: July 29, 2025


Introduction

Monobasic sodium phosphate (NaH₂PO₄) and dibasic sodium phosphate (Na₂HPO₄) are inorganic compounds predominantly used across pharmaceuticals, food processing, water treatment, and industrial applications. As key ingredients in buffering agents, laxatives, and nutritional products, their market dynamics have significant implications for stakeholders ranging from manufacturers to end-users. This comprehensive analysis explores the factors shaping their market, forecasts their financial trajectory, and underscores strategic considerations within this niche.


Market Overview

The global sodium phosphate market, valued at approximately USD 1.3 billion in 2022, is poised for steady growth driven by expanding pharmaceutical and food sectors. Monobasic and dibasic sodium phosphates constitute a substantial segment owing to their wide-ranging applications. Their dual role as food additives (E339) and pharmaceutical excipients underpins their robust demand.

The increasing prevalence of digestive health issues, especially among aging populations, amplifies demand for laxatives and electrolyte replenishment products containing these compounds. Concurrently, rising awareness of food safety standards and the necessity for pH regulation in processed foods contribute to market expansion.


Market Dynamics

Drivers

1. Growing Pharmaceutical Demand
The pharmaceutical sector's reliance on these compounds as excipients, buffering agents, and electrolyte replenishment solutions fosters consistent demand. Their critical role in intravenous solutions and laxatives ensures steady consumption.

2. Expansion in Food Industry
Food manufacturers utilize monobasic and dibasic sodium phosphates as acidity regulators, anti-caking agents, and emulsifiers. The global rise in processed food consumption, coupled with stringent food safety regulations, sustains demand.

3. Water Treatment Applications
Sodium phosphates are employed in water treatment to prevent corrosion and control pH levels. The expanding scope of municipal and industrial water treatment projects bolsters market growth.

4. Regulatory Support
FDA and EFSA approvals as food additives bolster market confidence and support demand continuity, especially in North America and Europe.

Challenges

1. Regulatory Scrutiny
In recent years, health concerns relating to phosphate additives—linked to cardiovascular issues and renal health—have prompted regulatory tightening. The European Food Safety Authority (EFSA) has issued warnings regarding excessive phosphate intake, limiting some uses.

2. Environmental Impact and Sustainability Concerns
Environmental considerations around phosphate mining and disposal may impose future regulatory constraints, affecting production costs and supply stability.

3. Competition and Price Volatility
The market faces price fluctuations owing to raw material supply constraints, geopolitical tensions impacting China—a major exporter—and fluctuating global demand cycles.

Opportunities

1. Technological Innovations
Advances in eco-friendly manufacturing processes and bio-based alternatives can enhance competitiveness and open new applications.

2. Emerging Markets
Rapid urbanization and infrastructural development in Asia-Pacific (notably India and China) are creating new demand pools, especially in pharmaceutical and food sectors.

3. Product Diversification
Developing new formulations that optimize bioavailability or reduce side-effects can expand market share, particularly in healthcare.


Financial Trajectory

Historical Performance

Over the past five years, the sodium phosphate market experienced moderate growth (~4% CAGR), driven by steady pharmaceutical and food industry demands. Market players like ICL IP, Innophos Holdings, and Spectrum Chemical have reported increased revenues from phosphate products, reflecting healthy market uptake.

Projected Market Trends

The next five years forecast a compound annual growth rate (CAGR) of approximately 5–6%, driven by expanding applications and regulatory acceptance. The Asia-Pacific region is anticipated to lead regional growth, with estimates of doubling the market share by 2028 due to increased demand in food processing and pharmaceuticals.

Revenue Forecasts

Based on current trends, the global market for these compounds could surpass USD 2.1 billion by 2028. The pharmaceutical segment is expected to grow at 6% CAGR, primarily due to rising demand for electrolyte solutions and laxatives. The food segment will contribute substantially, especially with expanding processed food markets in emerging economies.

Profitability Outlook

Profit margins are projected to stabilize around 10–12% for leading manufacturers, contingent upon raw material costs, regulatory compliance expenses, and technological advancements. Vertical integration and supply chain optimization will be crucial to margin preservation.


Competitive Landscape

The market is formed by a mix of multinationals and regional producers. Leading companies include:

  • ICL Group
  • Innophos Holdings
  • Spectrum Chemical
  • Tianjin Phosphates Corporation

Innovative R&D, capacity expansion, and strategic partnerships are key to maintaining competitive edges.


Regulatory Environment and Impact

Regulatory frameworks, predominantly led by the FDA, EFSA, and China's SFDA, influence manufacturing standards, permissible uses, and labeling. Increased oversight on phosphate additives in food aims to mitigate health risks but presents compliance challenges for suppliers. Future policies may lead to product reformulations or alternative additive development.


Strategic Considerations

  • Supply Chain Resilience: Diversifying sourcing channels to mitigate geopolitical and environmental risks.
  • Product Innovation: Developing low-phosphate or phosphate-reduced formulations to meet emerging health guidelines.
  • Regional Expansion: Strengthening presence in rapidly growing markets like India and Southeast Asia.
  • Sustainability Initiatives: Investing in eco-friendly production processes and waste management.

Key Takeaways

  • The sodium phosphate market, including monobasic and dibasic forms, exhibits consistent growth driven by pharmaceutical, food, and water treatment demands.
  • Regulatory scrutiny concerning health and environmental impacts warrants ongoing adaptation and innovation.
  • Market participants should focus on regional expansion, technological advancements, and sustainable practices to capitalize on emerging opportunities.
  • Price volatility and raw material costs remain key risk factors necessitating supply chain agility and strategic sourcing.
  • Forecasts indicate a robust upward trajectory, with potential to reach over USD 2 billion globally by 2028, aligning with broader industry trends toward health, safety, and sustainability.

FAQs

  1. What are the primary applications of monobasic and dibasic sodium phosphates?
    They are primarily used as buffering agents in pharmaceuticals, food additives for acidity regulation and preservation, and in water treatment to control pH and prevent corrosion.

  2. How are regulatory changes affecting the market?
    Increased health and safety regulations—aimed at moderating phosphate intake—are prompting manufacturers to optimize formulations, explore alternatives, and adhere to stricter labeling standards.

  3. What regional markets are experiencing the fastest growth?
    Asia-Pacific, driven by expanding food processing and healthcare sectors, is projected to see the fastest growth, followed by North America and Europe.

  4. What environmental factors influence market growth?
    Environmental concerns surrounding phosphate mining, waste disposal, and sustainability practices may lead to stricter regulations, impacting supply chains and manufacturing costs.

  5. What are key strategies for market players to remain competitive?
    Investing in R&D for innovative, eco-friendly products, strengthening regional presence, diversifying supply sources, and aligning with regulatory requirements are critical strategic moves.


References

[1] MarketWatch. "Sodium Phosphate Market Size, Share & Trends Analysis." 2022.
[2] Grand View Research. "Phosphates Market Forecast & Industry Analysis." 2023.
[3] EFSA. "Opinion on the Safety of Phosphates in Food." European Food Safety Authority, 2021.
[4] IHS Markit. "Chemical Industry Outlook: Phosphates Sector." 2022.
[5] Fact.MR. "Global Food Additives Market Growth Analysis." 2023.

More… ↓

⤷  Get Started Free

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.