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.

Seven 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:	7
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	216344-002	Oct 10, 2023	AP	RX	No	No
Amneal	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	218343-001	Jul 26, 2024		RX	Yes	Yes
Hospira	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	217459-001	Sep 11, 2025	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	11,813,291		Y

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
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
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
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016

Market Overview and Financial Trajectory for Potassium Phosphate (Dibasic and Monobasic)

Last updated: February 16, 2026

Current landscape indicates a niche but stable demand for potassium phosphate formulations, driven primarily by their use in nutritional, pharmaceutical, and industrial sectors. The market is influenced by regulatory environments, raw material costs, and technological innovations.

Market Size and Growth Drivers

• Estimated global market size for potassium phosphate compounds was valued at approximately $200 million in 2022 [1].
• Projected compound annual growth rate (CAGR) from 2023 to 2030 is around 4.5%, driven by increasing demand in total parenteral nutrition (TPN), food fortification, and pharmaceutical applications.
• The food industry accounts for roughly 55% of the demand, while pharmaceutical and nutraceutical sectors contribute 35% [2].

Key Market Segments

Segment Type	Share of Market (2022)	Main Applications
Food Additives	55%	Fortification, pH buffering
Pharmaceuticals (TPN)	25%	Electrolyte replenishment
Industrial Use	20%	Water treatment, corrosion control

Regional Market Distribution

Region	Market Share (2022)	Growth Rate (2023–2030)	Drivers
North America	30%	4.2%	Healthcare infrastructure, food safety regulations
Europe	25%	4.6%	Food industry regulation, pharmaceutical sector
Asia-Pacific	35%	4.8%	Large population, expanding healthcare, food industry
Rest of the World	10%	3.9%	Emerging markets, industrial applications

Pricing Trends and Raw Material Costs

• The average price for potassium phosphate (mixed monobasic/dibasic) is approximately $10 to $15 per kg [3].
• Vulnerable to raw material fluctuations; phosphate rock prices have increased by approximately 15% from 2020–2022 [4].
• Manufacturing costs are sensitive to energy prices, with electricity and natural gas comprising around 40% of production expenses.

Regulatory and Patent Environment

• Key regulatory bodies, including the FDA and EFSA, classify potassium phosphate as Generally Recognized as Safe (GRAS) when used within specified limits.
• Patent activity centers around novel formulations, delivery mechanisms, and manufacturing processes, with some filings dated post-2020 aimed at improving bioavailability and reducing manufacturing costs [5].
• Patent expirations are expected around 2027–2030, opening opportunities for generic production.

Competitive Landscape

Major players include:

• EMD Millipore (MERCK KGaA)
• FMC Corporation
• Nippon Chemical Industrial Co., Ltd.
• Taj Pharmaceuticals Ltd.

Market share distribution indicates high fragmentation, with no single company controlling more than 20% of the market.

Financial Outlook

• Revenue growth for approved formulations is projected to reach $250–$300 million by 2030, assuming continued demand and successful patent management.
• Profit margins are heavily dependent on raw material costs and manufacturing efficiencies; margins are projected at 15–20% for established producers.
• Investment in R&D, especially for novel delivery forms, presents potential for high-margin opportunities.

Key Challenges

• Price volatility driven by raw material costs.
• Stringent regulatory standards requiring ongoing compliance.
• Competition from generics post-patent expiration.

Opportunities

• Expansion in emerging markets.
• Development of specialized formulations for targeted medical therapies.
• Innovations in manufacturing to reduce costs and improve purity.

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Key Takeaways

• The market for potassium phosphate compounds remains steady with modest growth, primarily driven by healthcare and food sectors.
• Pricing remains stable but can be affected by raw material costs and regulatory compliance.
• Patent expirations and technological advancements offer opportunities for new entrants or generic manufacturers.
• Regional growth is strongest in Asia-Pacific, with mature markets in North America and Europe maintaining steady demand.
• Innovation in formulation and delivery methods could diversify the product portfolio and enhance margins.

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FAQs

1. What factors influence the price of potassium phosphate?
Raw material costs, energy prices, regulatory compliance expenses, and market demand fluctuations influence pricing. Phosphate rock price increases have historically driven higher raw material costs.

2. How does patent expiration affect market competition?
Patent expirations around 2027–2030 may enable generics and formulations with improved features, increasing competition and possibly reducing prices.

3. Which sectors are the largest consumers of potassium phosphate?
Food fortification and medical nutrition (especially TPN) are the primary consumers, accounting for over 75% combined.

4. What regulatory challenges exist for new market entrants?
Compliance with safety standards and securing approvals from bodies like the FDA or EFSA are essential. Existing regulations limit the permissible levels in food and pharmaceuticals, necessitating compliance strategies.

5. Is there potential for new and innovative applications?
Yes. Emerging applications include targeted drug delivery systems, biodegradable medical devices, and specialty nutritional supplements.

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Citations

1. MarketsandMarkets, "Potassium Phosphate Market," 2022.
2. Grand View Research, "Food Additive Ingredients," 2021.
3. Industry pricing reports, Q4 2022.
4. US Geological Survey, "Phosphate Rock Data," 2022.
5. Patent databases, WIPO, 2022.