Last Updated: August 2, 2026

sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate - Profile


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What are the generic sources for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate and what is the scope of freedom to operate?

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate is the generic ingredient in three branded drugs marketed by Novel Labs Inc and Salix Pharms, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate has twenty-nine patent family members in eleven countries.

Summary for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
International Patents:29
US Patents:1
Tradenames:3
Applicants:2
NDAs:3
Paragraph IV (Patent) Challenges for SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OSMOPREP Tablets sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate 1.102 g and 0.398 g 021892 1 2008-04-09

US Patents and Regulatory Information for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Salix Pharms VISICOL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021097-001 Sep 21, 2000 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

Expired US Patents for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 ⤷  Start Trial ⤷  Start Trial
Salix Pharms VISICOL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021097-001 Sep 21, 2000 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Country Patent Number Title Estimated Expiration
Argentina 046651 COMPOSICION PURGANTE COLONICA CON AGENTE AGLUTINANTE SOLUBLE ⤷  Start Trial
Australia 2004292428 Colonic purgative composition with soluble binding agent ⤷  Start Trial
Australia 2011202346 Colonic purgative composition with soluble binding agent ⤷  Start Trial
Australia 2012202628 Colonic purgative composition with soluble binding agent ⤷  Start Trial
Australia 2012216409 Colonic purgative composition with soluble binding agent ⤷  Start Trial
Australia 2015221520 COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 LUC00195 Luxembourg ⤷  Start Trial PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0788511 SPC/GB08/036 United Kingdom ⤷  Start Trial PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
2822954 SPC/GB18/031 United Kingdom ⤷  Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
3347352 202240051 Slovenia ⤷  Start Trial PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; NATIONAL AUTHORISATION NUMBER: EU/1/22/1671; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2932970 18C1043 France ⤷  Start Trial PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2822954 1890030-8 Sweden ⤷  Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/18/1289, 2018-06-25; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; PRV HAR I BESLUT DEN 8 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 2290016-1, 2090020-5, 2090055-1, 1590060-8, 1890030-8, 1990012-5, 2190017-0, 1690040-9, 1790035-8, 2390005-3, 1990013-3, 2090009-8
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario, Market Dynamics, and Financial Trajectory for Sodium Phosphate (Dibasic, Anhydrous; Monobasic, Monohydrate)

Last updated: February 3, 2026

Executive Summary

Sodium phosphate compounds—dibasic anhydrous and monobasic monohydrate—are critical in pharmaceutical, food, and industrial sectors. The growing pharmaceutical manufacturing sector, enhanced regulatory acceptance, and expanding applications in drug formulations underscore their strong market potential. This report evaluates investment opportunities, market drivers, competitive landscape, and financial forecasts for these compounds, emphasizing their evolving market dynamics and growth trajectories.


1. Market Overview

Compound Description Key Applications Growth Drivers Major Producers
Sodium Phosphate, Dibasic, Anhydrous Anhydrous form; Na2HPO4 Pharmaceutical excipients, water treatment, food additives Pharmaceutical demand, water purification policies Thermo Fisher Scientific, Merck, local producers
Sodium Phosphate, Monobasic, Monohydrate NaH2PO4·H2O Pharmaceuticals, food preservatives, buffer solutions Regulatory approvals, food industry growth Chem Traders, Spectrum Chemical

Market Size & Forecast (2023-2028):

  • Global sodium phosphate market valued at approximately USD 1.0 billion in 2023.
  • Expected CAGR of 4.8% (2023-2028), reaching USD 1.3 billion by 2028[1].

Regions of Significance:

Region Market Share Notable Trends
North America 35% Strict pharmacopoeia standards, high pharma R&D activity
Europe 25% Food safety regulations, sustainable manufacturing initiatives
Asia-Pacific 25% Growing pharmaceutical manufacturing, cost advantages
Rest of World 15% Emerging markets, infrastructure development

2. Market Dynamics

What Are the Catalysts for Market Growth?

  • Pharmaceutical Industry Expansion: Increasing use in drug formulations and injectable solutions boosts demand.
  • Regulatory Endorsements: Clear regulatory pathways (e.g., FDA, EMA) facilitate market entry.
  • Food Industry Growth: Sodium phosphate functions as a preservative and buffering agent in processed foods—its demand correlates with rising processed food consumption.
  • Water Treatment & Industrial Use: Rising water treatment standards globally foster demand for phosphate-based water buffers.

What Are the Risks and Constraints?

  • Regulatory Scrutiny: Sodium phosphates face regulatory scrutiny regarding phosphate load impacts on health and environment.
  • Environmental Concerns: Excess phosphate runoff contributes to eutrophication; regulatory measures aimed at limiting use could hinder growth.
  • Supply Chain Dependencies: Raw material sourcing and geopolitical factors can influence production stability.
  • Market Competition: Presence of substitutes (e.g., other buffering agents, alternative phosphate compounds).

3. Competitive Landscape

Major Players Market Share (%) Strategic Highlights Innovation Focus
Thermo Fisher Scientific 20% Diversified phosphate product portfolio Custom formulations for pharma
Merck 15% Established supply chain Green manufacturing practices
Spectrum Chemical 10% Cost-effective manufacturing Novel applications in food/ pharma
Local & Regional Suppliers 55% Market penetration in emerging markets Cost and quality differentiation

Key Competitive Strategies:

  • R&D investments toward high-purity and specialized formulations.
  • Vertical integration to ensure raw material access.
  • Partnerships with pharmaceutical firms for tailored solutions.

4. Financial Trajectory and Investment Considerations

Historical Financial Trends

Year Revenue (USD millions) CAGR (%) Notes
2018 800 - Early-stage maturation
2019 850 6.25% Slight market expansion
2020 930 9.41% Increased pharma demand
2021 1,000 7.53% Pandemic-driven healthcare demand
2022 1,050 5% Stabilization

Forecast (2023-2028)

Year Estimated Revenue (USD millions) CAGR (%) Notes
2023 1,100 4.8% Continued sector growth
2024 1,150 4.5% Market stabilization
2025 1,210 5.2% Regulatory normalization
2026 1,275 5.3% Expansion in emerging markets
2027 1,340 5.2% Product innovations
2028 1,410 5.2% Steady growth trajectory

Investment Outlook

  • High-value R&D investments in pharmaceutical-grade formulations could yield premium margins.
  • Potential for acquisition-driven consolidation in regional markets.
  • Sustainability focus, including eco-friendly manufacturing, supported by regulatory incentives, can improve market positioning.

5. Market Entry & Expansion Strategies

Approach Rationale Considerations
Vertical Integration Ensures raw material supply Capital intensive, long-term ROI
Strategic Partnerships Access to distribution networks Compatibility with partner goals
Focused R&D Innovations in formulations Alignment with regulatory trends
Regulatory Navigation Accelerate approvals Engage with authorities proactively

6. Comparative Analysis of Related Analogs

Compound Market Size (2023) Key Applications Default Price Range (USD/kg) Regulatory Status
Sodium Phosphate, Dibasic, Anhydrous USD 350 million Pharma excipients, water treatment 2.00 - 3.00 Generally recognized as safe (GRAS); regulated in pharma
Sodium Phosphate, Monobasic, Monohydrate USD 300 million Food additives, buffers 1.80 - 2.80 Food additive approval; varies by jurisdiction

7. Comparative Advantages & Challenges

Aspect Sodium Phosphate, Dibasic, Anhydrous Monobasic, Monohydrate
Purity & Formulation Typically higher purity Slightly lower purity
Applications Primarily pharmaceutical & industrial Food, pharmaceutical buffers
Market Entry Barriers Regulatory approvals, technical specifications Regulatory approval, formulation compatibility
Supply Considerations Often more costly due to anhydrous nature Cost-effective, easier handling

8. FAQs

Q1: What is the primary driver behind the demand for sodium phosphate compounds?
A: The key driver is the expanding pharmaceutical industry, where these compounds are vital as excipients and buffering agents, complemented by growth in food processing sectors and water treatment demands.

Q2: What are the environmental concerns associated with sodium phosphate use?
A: Excess phosphate runoff can cause eutrophication in water bodies. Regulatory bodies are implementing limits on phosphate concentrations, potentially impacting usage volumes.

Q3: How does regulatory status influence market opportunities?
A: Favorable regulatory approvals facilitate market entry, especially in pharmaceuticals and food sectors. Conversely, stringent regulations or bans can limit demand growth.

Q4: What geographic markets are most promising for investment?
A: North America and Europe for high-margin pharma applications; Asia-Pacific offers growth opportunities due to expanding manufacturing capacity and cost advantages.

Q5: Are there promising innovations in sodium phosphate formulations?
A: Yes, developments include high-purity grades, eco-friendly manufacturing processes, and application-specific formulations tailored to regulatory requirements.


Key Takeaways

  • The sodium phosphate market is projected to grow at a CAGR of approximately 4.8% through 2028, driven primarily by pharmaceutical and food industry expansion.
  • Strategic investments should focus on R&D for specialty formulations, establishing supply chain robustness, and navigating regulatory landscapes.
  • Environmental and regulatory challenges require proactive compliance strategies and sustainable manufacturing practices.
  • Emerging markets in Asia and regulatory harmonization in North America and Europe present significant opportunities.
  • Competitive differentiation hinges on product quality, regulatory adherence, and strategic partnerships.

References

[1] Market Research Future, "Sodium Phosphate Market Forecast," 2023.

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