POTASSIUM PHOSPHATES Drug Patent Profile

When do Potassium Phosphates patents expire, and when can generic versions of Potassium Phosphates launch?

Potassium Phosphates is a drug 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 drug.

This drug has one patent family member in one country.

The generic ingredient in POTASSIUM PHOSPHATES is potassium phosphate, dibasic; potassium phosphate, monobasic. There are two hundred and forty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.

DrugPatentWatch^® Generic Entry Outlook for Potassium Phosphates

Indicators of Generic Entry

Summary for POTASSIUM PHOSPHATES

International Patents:	1
US Patents:	1
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	1
What excipients (inactive ingredients) are in POTASSIUM PHOSPHATES?	POTASSIUM PHOSPHATES excipients list
DailyMed Link:	POTASSIUM PHOSPHATES at DailyMed

Recent Clinical Trials for POTASSIUM PHOSPHATES

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mahidol University	N/A

See all POTASSIUM PHOSPHATES clinical trials

Pharmacology for POTASSIUM PHOSPHATES

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 PHOSPHATES

POTASSIUM PHOSPHATES is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-001	Oct 2, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-004	May 9, 2025		RX	Yes	Yes	11,925,661		Y
Cipla	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	217892-001	Jan 24, 2025	AP	RX	No	No
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-001	Oct 10, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-002	Nov 26, 2019	AP	RX	Yes	Yes
Fresenius Kabi Usa	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-005	May 9, 2025		RX	Yes	Yes	11,925,661		Y
Cipla	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	217892-002	Jan 24, 2025	AP	RX	No	No

International Patents for POTASSIUM PHOSPHATES

See the table below for patents covering POTASSIUM PHOSPHATES around the world.

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

Supplementary Protection Certificates for POTASSIUM PHOSPHATES

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 Phosphates

Last updated: July 28, 2025

Introduction

Potassium phosphates, a class of inorganic salts, are essential components in various pharmaceutical, food, and industrial applications. Their pharmacological significance stems from their role as mineral supplements and buffering agents, with increasing demand driven by growing health awareness and expanding pharmaceutical markets globally. This analysis examines the current market landscape, influencing factors, and the projected financial trajectory for potassium phosphates, emphasizing scientists, investors, and industry stakeholders seeking data-driven insights.

Global Market Overview

The potassium phosphates market is characterized by steady growth, underpinned by rising applications in the pharmaceutical industry, food manufacturing, and industrial sectors. In 2022, the global demand was estimated at approximately $250 million, with projections suggesting a CAGR of 4.2% through 2030 (Research by Grand View Research). The primary drivers include increased prevalence of mineral deficiencies, expanding pharmaceutical R&D, and regulatory approvals promoting mineral-based therapies.

Applications and End-Use Sectors

• Pharmaceuticals: As mineral supplement ingredients in electrolyte formulations and IV fluids, potassium phosphates are vital for managing hypokalemia and other electrolyte disorders.
• Food Industry: Used as leavening agents, acidity regulators, and nutritional supplements, the food sector accounts for about 35% of demand.
• Industrial Uses: Water treatment and electrochemical applications also contribute, albeit to a lesser extent.

Regional Market Distribution

North America and Europe dominate the market, with share percentages of approximately 40% and 25%, respectively, due to advanced healthcare infrastructure and stringent regulatory standards. The Asia-Pacific region exhibits the highest growth potential, driven by expanding healthcare sectors, increasing urbanization, and rising awareness of mineral supplementation.

Market Dynamics

Drivers

• Rising Incidence of Mineral Deficiencies
  Global surveys report increasing cases of hypokalemia, especially among the elderly and those with chronic illnesses. The World Health Organization estimates that about 20% of the global population suffers from mineral deficiencies, fostering sustained demand for mineral-based supplements like potassium phosphates.

• Growth in Pharmaceutical Sector
  Evolving treatment protocols emphasizing electrolyte rebalancing, coupled with the expansion of IV therapy, bolsters demand. The global electrolyte solutions market is projected to reach $3.8 billion by 2025 (Research by MarketsandMarkets).

• Regulatory Support and R&D
  Stringent safety assessments and approval processes in regulated markets like the US FDA and EMA have spurred innovation. Increasing approvals for potassium phosphate-based drugs foster market stability.

Challenges

• Price Volatility of Raw Materials
  Prices of phosphoric acid, a primary raw material, experience fluctuations due to geopolitical unrest, supply chain disruptions, and environmental regulations affecting phosphate mining.

• Environmental Regulations
  Stricter environmental laws aimed at sustainable mining practices and waste management raise operational costs, potentially impacting profit margins.

• Substitution Risks
  Emergence of alternative mineral compounds or synthetic substitutes may challenge traditional potassium phosphate applications.

Competitive Landscape

Major players include subject to patent protections, such as FMC Corporation, Mosaic Company, and Nutritional Federal (Nutritional Federal), with numerous regional manufacturers competing on price and quality. Continued innovation, such as developing specialized formulations or eco-friendly manufacturing processes, provides differentiation opportunities.

Financial Trajectory and Market Forecast

Historical Performance

From 2018 to 2022, the market exhibited a compound annual growth rate of approximately 3.8%. Revenue stability is linked to expanding healthcare access and food industry growth, with notable fluctuations tied to raw material costs and supply chain issues during the COVID-19 pandemic.

Projected Growth and Revenue

Forecasts anticipate that by 2030, the market size will reach approximately $370 million, driven by increased pharmaceutical applications and regional market expansion:

Year	Market Size (USD Million)	CAGR (%)
2022	250	—
2025	300	4.2
2030	370	4.2

Financial Contributors

• Pharmaceutical Applications: Expected to sustain the highest growth, at a CAGR of 5% to 6%, fueled by new drug approvals and an aging population.
• Food & Beverage Sector: A steady growth segment, with a CAGR around 3.8%, as clean label and mineral-enriched foods become standard.
• Industrial Sector: Moderate growth predicted, with CAGR near 2.5%, constrained by environmental policies.

Profitability Outlook

Gross margins are projected to remain stable at approximately 15-20%, primarily constrained by raw material costs. R&D investments toward formulation innovations are strategic priorities, aiming to enhance efficacy and environmental sustainability, potentially commanding premium pricing.

Strategic Market Opportunities

• Emerging Markets: India and China present vast opportunities due to larger populations and expanding healthcare infrastructure.
• Formulation Innovation: Development of stable, bioavailable potassium phosphate complexes can offer competitive advantages.
• Sustainable Production: Investing in environmentally friendly manufacturing aligns with regulatory trends and consumer preferences.

Key Market Risks

• Regulatory Delays: Lengthy approval processes can delay market entry for new formulations.
• Supply Chain Disruptions: Overdependence on specific raw material sources exposes manufacturers to geopolitical and environmental shocks.
• Pricing Pressures: Intense competition may lead to price erosion, affecting profitability.

Regulatory and Patent Landscape

Patent protections for innovative formulations and manufacturing processes impact market exclusivity. Patent expirations may lead to generic manufacturing, intensifying price competition. Regulatory bodies’ evolving guidelines require continuous compliance efforts, especially for pharmaceutical-grade potassium phosphates.

Conclusion

The potassium phosphates market is poised for stable yet nuanced growth over the next decade. Its trajectory hinges on expanding pharmaceutical applications, regional market development, and sustainable manufacturing practices. Strategic positioning—focused on innovation, supply chain resilience, and regulatory navigation—will be pivotal for industry stakeholders aiming to capitalize on emerging opportunities.

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Key Takeaways

• The global market is projected to grow at a CAGR of approximately 4.2% through 2030, driven mainly by pharmaceutical and food industry demands.
• North America and Europe currently lead, but Asia-Pacific offers significant growth potential.
• Raw material price volatility and environmental regulations present notable challenges.
• Innovation in formulations and sustainable manufacturing can provide competitive differentiation.
• Regulatory landscapes and patent statuses influence market entry, pricing, and profitability strategies.

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FAQs

1. What are the main applications of potassium phosphates in the pharmaceutical industry?
Primarily used as mineral supplements in electrolyte solutions and intravenous therapies to correct hypokalemia and electrolyte imbalances.

2. How does regional regulation impact market growth for potassium phosphates?
Stringent regulations in developed markets can delay approvals but foster high-quality standards, potentially limiting supply but ensuring market stability. Emerging regions offer growth opportunities with evolving regulatory frameworks.

3. What factors influence raw material prices for potassium phosphates?
Global phosphate mining restrictions, geopolitical factors, environmental policies, and fluctuating demand in related industries (e.g., fertilizer production) impact costs.

4. Are there any notable innovations in potassium phosphate formulations?
Yes, researchers are developing bioavailable complexes, eco-friendly syntheses, and formulations with enhanced stability, improving application efficacy and sustainability.

5. How might environmental regulations affect future market dynamics?
Stricter environmental laws may increase manufacturing costs and limit supply, but also drive innovation toward sustainable production methods that could create differentiation and compliance advantages.

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References

1. Grand View Research. "Potassium Phosphates Market Size, Share & Trends Analysis Report." 2022.
2. MarketsandMarkets. "Electrolyte Solutions Market by Product, Application, and Region." 2020.
3. World Health Organization. "Mineral Deficiencies Global Report." 2021.