POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC - Generic Drug Details

What are the generic drug sources for potassium phosphate, dibasic; potassium phosphate, monobasic and what is the scope of patent protection?

Potassium phosphate, dibasic; potassium phosphate, monobasic is the generic ingredient in two branded drugs marketed by Am Regent, Amneal, Cipla, Cmp Dev Llc, Fresenius Kabi Usa, Hospira, and Somerset Theraps Llc, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Potassium phosphate, dibasic; potassium phosphate, monobasic has one patent family member in one country.

Eight suppliers are listed for this compound.

Summary for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

International Patents:	1
US Patents:	3
Tradenames:	2
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
DailyMed Link:	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC at DailyMed

Pharmacology for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

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

US Patents and Regulatory Information for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-003	Oct 10, 2023	AP	RX	No	No
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-002	Oct 2, 2023	AP	RX	No	No
Cipla	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	217892-003	Jan 24, 2025	AP	RX	No	No
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-003	Oct 2, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-003	Nov 26, 2019	AP	RX	Yes	Yes
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-002	Nov 26, 2019	AP	RX	Yes	Yes
Somerset Theraps Llc	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	217726-002	Jul 11, 2024	AP	RX	No	No

International Patents for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020081118

Supplementary Protection Certificates for POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209

Market Dynamics and Financial Trajectory for Potassium Phosphate, Dibasic and Monobasic

Last updated: July 29, 2025

Introduction

Potassium phosphates, specifically dibasic (K₂HPO₄) and monobasic (KH₂PO₄), play an essential role across multiple sectors, including pharmaceuticals, food and beverage, agriculture, and industrial applications. Their widespread utility stems from their properties as buffering agents, nutritional supplements, and industrial additives. As demand escalates driven by healthcare advancements and food safety regulations, understanding the market dynamics and financial trajectory of these compounds becomes vital for stakeholders.

Market Overview

The global potassium phosphate market is experiencing steady growth, supported by increasing demand for nutrient supplementation, rising prevalence of chronic diseases requiring intravenous therapy, and food safety regulations promoting micronutrient fortification. The market’s valuation is projected to reach approximately USD 550 million by 2028, growing at a compound annual growth rate (CAGR) of around 4.5% from 2023-2028 [1].

Supply Chain and Production

Main production sources include chemical manufacturing plants operated by major pharmaceutical and chemical companies, with key manufacturing regions spanning North America, Europe, and Asia-Pacific. The supply chain involves raw material procurement (phosphoric acid and potassium compounds), synthesis, purification, and packaging.

Factors influencing production include raw material prices, technological advancements in synthesis, and environmental regulations. Fluctuations in phosphoric acid prices, often tied to global energy markets, impact overall manufacturing costs.

Market Drivers

Healthcare and Nutritional Applications

Potassium phosphate compounds are integral in medical nutritional formulations, including total parenteral nutrition (TPN) solutions and intravenous (IV) therapies. Their role in maintaining electrolyte balance makes them critical in clinical settings, especially in patients with kidney disease, electrolyte imbalances, or undergoing dialysis. The rising incidence of such conditions globally propels demand.

Food Industry and Fortification

Food and beverage sectors leverage potassium phosphates as acidity regulators, buffering agents, and nutritional fortifiers. Regulatory bodies, such as the U.S. FDA and EFSA, endorse their safe use, bolstering their adoption. The trend of micronutrient fortification to combat deficiencies supports increased usage.

Agricultural and Industrial Use

While less dominant, potassium phosphates serve as fertilizers providing essential nutrients for crop yield, and as sequestrants in industrial processes, such as water treatment and cleaning agents.

Regulatory Environment

Tightening regulations on food additives and pharmaceuticals demand stricter quality controls. Certification requirements, such as Good Manufacturing Practices (GMP) and compliance with the European Food Safety Authority (EFSA) standards, influence production standards and costs.

Market Challenges

Raw Material Price Volatility

The price of phosphoric acid, a primary raw material, directly affects manufacturing costs. Energy prices and geopolitical tensions in key supplier regions (e.g., China and Morocco) can disrupt supply and lead to price volatility.

Environmental Regulations

Environmental concerns regarding waste management and emissions in phosphate processing prompt stricter regulations, potentially increasing operational costs and impeding supply expansion.

Competitive Landscape and Patents

While potassium phosphates are generally open commodities, proprietary formulations for specific medical applications or food products could limit generic competition, impacting pricing strategies.

Technological Innovation and R&D

Advances in synthesis processes, such as cleaner production methods and improved purification techniques, are reducing costs and environmental footprints. R&D efforts focus on developing more bioavailable forms for nutritional applications and sustainable production pathways.

Financial Trajectory Analysis

Revenue Projections

The increasing demand across sectors suggests a robust revenue trajectory. The pharmaceutical segment, driven by rising chronic disease prevalence, is forecasted to grow at a CAGR of 5%, while the food fortification market expects a CAGR of 4%. Cumulatively, revenues for potassium phosphate compounds are expected to reach USD 550 million by 2028 [1].

Profitability Metrics

Profit margins are influenced by raw material costs, regulatory compliance expenses, and competition levels. Companies investing in vertical integration of raw material sourcing and technological innovations are likely to maintain higher margins.

Market Entry and Expansion Strategies

New entrants focus on sustainable production, high-purity grades, and tailored formulations for niche pharmaceutical applications. Strategic acquisitions and alliances with biotech firms bolster market reach.

Regional Market Trends

• North America: Largest consumer due to advanced healthcare infrastructure and strict food safety regulations.
• Europe: Growth driven by regulatory standards promoting fortified foods and specialized medical formulations.
• Asia-Pacific: Rapidly expanding due to rising healthcare access, industrialization, and urbanization, despite being primarily a manufacturing hub for raw materials.

Competitive Landscape

Key industry players include companies such as:

• ICL Group Ltd.
• AkzoNobel Specialty Chemicals
• Gadot Biochemical Industries Ltd.
• E.I. du Pont de Nemours and Company
• FMC Corporation

These firms focus on capacity expansion, product diversification, and adherence to regulatory standards to sustain market positions.

Future Outlook

The market for potassium phosphates, principally dibasic and monobasic forms, is poised for steady growth driven by health, food safety, and industrial demands. Emerging markets, technological advances in sustainable manufacturing, and evolving regulations will shape the long-term financial trajectory.

Key Trends to Monitor

• Integration of green chemistry practices
• Growth of bioavailable and specialty formulations
• Expansion into emerging markets
• Impact of geopolitical and environmental policies on supply chains

Key Takeaways

• The potassium phosphate market is projected to grow at a CAGR of approximately 4.5% through 2028, reaching USD 550 million.
• Healthcare, particularly nutrition and IV therapies, remains the primary driver, compounded by rising chronic disease cases.
• Food fortification and industrial uses contribute to diversification, supporting steady revenue streams.
• Raw material price volatility and environmental regulations pose ongoing challenges but also lucrative R&D opportunities.
• Strategic investments in sustainable production and innovation are vital for long-term profitability and competitive advantage.

FAQs

1. What factors most significantly influence the pricing of potassium phosphate compounds?
Raw material costs, particularly phosphoric acid prices, geopolitical factors, environmental compliance expenses, and supply-demand dynamics are critical pricing influences.

2. How is the COVID-19 pandemic affecting the potassium phosphate market?
The pandemic has heightened demand for intravenous nutrient formulations, while supply chain disruptions initially caused fluctuations in raw material availability and costs.

3. Are there emerging applications for potassium phosphates in biotechnology?
Yes, research exploring new bioavailable formulations and their role in drug delivery systems is gaining momentum, expanding the market for specialty potassium phosphate derivatives.

4. What regions are expected to see the highest growth in demand?
Asia-Pacific, driven by developing economies, and North America, owing to technological adoption and healthcare investments, are anticipated to see significant growth.

5. What sustainability initiatives are companies adopting in potassium phosphate production?
Companies are investing in cleaner synthesis processes, recycling phosphoric waste, and reducing energy consumption to align with stringent environmental regulations.

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Sources:
[1] MarketResearch.com, “Global Potassium Phosphate Market Report 2023-2028.”