Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate - Generic Drug Details

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
DailyMed Link:	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate at DailyMed

Pharmacology for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AG	Enemas
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

V03AG	Drugs for treatment of hypercalcemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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
Salix Pharms	VISICOL	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021097-001	Sep 21, 2000

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

Country	Patent Number	Title	Estimated Expiration
China	102648980	Colonic purgative composition with soluble binding agent
Brazil	122014001142	Formulação purgativa colônica, kit, método de purgar o cólon de um paciente, e, processo de produzir a formulação purgativa colônica
European Patent Office	1682098	COMPOSITION PURGATIVE POUR LE COLON A AGENT DE LIAISON SOLUBLE (COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT)
Poland	1682098
Australia	2012216409	Colonic purgative composition with soluble binding agent
Argentina	046651	COMPOSICION PURGANTE COLONICA CON AGENTE AGLUTINANTE SOLUBLE

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	SPC/GB20/016	United Kingdom		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2340828	LUC00195	Luxembourg		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
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819

Market Dynamics and Financial Trajectory for Sodium Phosphate, Dibasic, Anhydrous and Monobasic, Monohydrate

Last updated: August 2, 2025

Introduction

Sodium phosphate derivatives, primarily dibasic anhydrous (Na₂HPO₄) and monobasic monohydrate (NaH₂PO₄·H₂O), are pivotal in various industrial, pharmaceutical, and food segments. Their unique chemical properties—such as buffering capacity, solubility, and safety profiles—drive diverse applications from medical formulations to water treatment. Understanding their market dynamics and financial trajectory is crucial for stakeholders aiming to navigate competitive landscapes, investment strategies, and R&D initiatives.

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Market Overview

The global demand for sodium phosphate compounds encompasses multiple sectors:

• Pharmaceutical Industry: As essential excipients, laxatives, and electrolyte replenishment solutions.
• Food Industry: As acidity regulators, emulsifiers, and leavening agents.
• Water Treatment and Agriculture: For pH stabilization and as buffering agents.
• Industrial Applications: In detergents, ceramics, and construction materials.

The combined market size of sodium phosphates is projected to grow at a CAGR of approximately 4% between 2023 and 2028, driven by increasing pharmaceutical usage and expanding food safety standards worldwide.

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Market Drivers

1. Rising Pharmaceutical Applications

Sodium phosphate salts serve as active pharmaceutical ingredients (APIs) and excipients in laxatives and bowel cleansing products. The growing prevalence of gastrointestinal disorders and aging populations fuel demand. Furthermore, sodium phosphate’s role in intravenous rehydration solutions and electrolyte balance management enhances its significance in healthcare.

2. Food Industry Expansion

Stringent regulatory standards regarding food additives, coupled with a surge in processed food consumption, propel the use of sodium phosphates as acidity regulators and stabilizers. The clean-label movement and demand for minimally processed foods favor formulations incorporating these compounds.

3. Water Treatment and Environmental Concerns

Increased urbanization and industrialization necessitate effective pH buffering and scaling prevention in water systems. Sodium phosphate compounds are favored due to their efficacy and low toxicity profiles.

4. Regulatory and Environmental Factors

Environmental repercussions of phosphate runoff, such as eutrophication, pressure regulatory bodies to restrict phosphate use in certain applications, especially in agriculture and detergents. These regulatory restrictions impact market growth trajectories, creating a shift toward alternative formulations or synthetic replacements.

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Market Challenges

• Environmental Restrictions: Phosphate bans in detergents and fertilizers in regions like the EU and certain U.S. states constrain market expansion.

• Supply Chain Constraints: Raw material volatility, especially phosphoric acid supplies, affects production costs and pricing strategies.

• Pricing Volatility: Fluctuations in raw material costs lead to inconsistent profit margins.

• Alternatives and Substitutes: Growing adoption of phosphate-free formulations in food and cleaning products can displace traditional sodium phosphate utilization.

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Financial Trajectory

Revenue Growth and Forecasts

Financial estimates project the sodium phosphate market to reach approximately USD 1.2 billion by 2028, with a compound annual growth rate (CAGR) of about 4%. Leading players such as FMC Corporation, Prayon Group, and Potash Corporation dominate the landscape, investing heavily in R&D to optimize formulations and develop environmentally benign variants.

Profitability and Cost Factors

Profitability margins are heavily influenced by raw material costs – notably phosphate rock and sulfuric acid. Technological advancements in manufacturing, such as membrane electrolysis and enhanced processing techniques, improve yield efficiencies and reduce unit costs, bolstering margins.

Investment Trends

Venture capital and private equity investments channel toward biotech firms developing phosphate-based therapies and biodegradable alternatives. Furthermore, mergers and acquisitions among chemical giants aim to consolidate supply chains and expand geographic reach.

Impact of Regulatory Policies

Stringent environmental standards, like restrictions on phosphate content, threaten revenue streams from traditional applications but also incentivize diversification into niche markets such as pharmaceutical-grade products or low-phosphate formulations, presenting both risk and opportunity.

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Regional Market Dynamics

• North America: Established pharmaceutical and food sectors ensure steady demand, though regulatory restrictions on phosphates in detergents affect application scope.

• Europe: Regulatory bottlenecks due to environmental policies suppress growth, encouraging R&D into eco-friendly derivatives.

• Asia-Pacific: Rapid industrialization, urbanization, and expanding healthcare infrastructure bolster demand, positioning the region as a significant growth nexus.

• Rest of World: Emerging markets in Latin America, Africa, and the Middle East show increasing interest in pharmaceutical and food applications, albeit constrained by supply chain and regulatory factors.

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Strategic Outlook

Stakeholders should prioritize:

• Diversification: Expanding into pharmaceutical-grade applications and specialty derivatives to mitigate market volatility.
• Innovation: Developing formulations with reduced phosphate content or alternative buffering agents aligning with environmental directives.
• Supply Chain Optimization: Securing raw material sources and investing in sustainable production technologies.
• Regulatory Engagement: Collaborating with policymakers to influence standards that balance environmental concerns with industry growth.

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Key Takeaways

• The sodium phosphate market is experiencing steady growth driven by pharmaceutical and food industry expansions, with regional variations dictated by regulatory and environmental factors.
• Environmental restrictions present both challenges and catalysts for innovation, pushing companies toward eco-friendly and phosphate-free alternatives.
• Technology investments improving production efficiency will influence profitability, with raw material costs remaining pivotal.
• Asia-Pacific offers high-growth opportunities, but supply chain resilience remains critical.
• Strategic diversification and proactive regulatory engagement are vital for sustained financial performance.

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FAQs

Q1: What factors are most influencing the demand for sodium phosphate derivatives globally?
A: Key factors include increasing pharmaceutical usages, growth in processed foods, water treatment needs, and regulatory policies affecting phosphate applications.

Q2: How are environmental regulations impacting the sodium phosphate market?
A: Restrictions on phosphate use in detergents and fertilizers reduce demand in certain sectors, prompting industry shifts toward eco-friendly alternatives and innovation in formulations.

Q3: What are the main applications of sodium dibasic anhydrous vs. monobasic monohydrate?
A: Sodium dibasic anhydrous is primarily used in water treatment, food processing, and as an excipient; monobasic monohydrate mainly functions in pharmaceutical applications, such as laxatives and electrolyte solutions.

Q4: Which regions are poised to dominate the sodium phosphate market in the coming years?
A: North America and Asia-Pacific are expected to lead demand, driven by healthcare infrastructure and industrialization, respectively.

Q5: What are the key innovations expected to shape the future of sodium phosphate manufacturing?
A: Innovations include sustainable manufacturing processes, phosphate recovery and recycling techniques, and development of phosphate-free or low-phosphate formulations for compliance and environmental sustainability.

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Sources:

[1] MarketWatch, "Global Sodium Phosphate Market Forecast," 2023.
[2] Allied Market Research, "Phosphates Market Trends," 2022.
[3] European Environment Agency, "Regulatory Impacts on Phosphate Use," 2021.
[4] Industry Reports, "Pharmaceutical Excipients Market," 2022.
[5] PR Newswire, "Investment Trends in Chemical Industry," 2023.