POTASSIUM CHLORIDE - Generic Drug Details

What are the generic sources for potassium chloride and what is the scope of patent protection?

Potassium chloride is the generic ingredient in forty-five branded drugs marketed by Savage Labs, Upsher Smith Labs, Nesher Pharms, Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Glenmark Pharms Ltd, Granules, Lupin Ltd, Novel Labs Inc, Padagis Us, Ph Health, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Genus, Ajenat Pharms, Amneal, Anda Repository, Epic Pharma Llc, Novitium Pharma, Rubicon Research, Kv Pharm, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus, Pharma Serve Ny, Watson Labs, Otsuka Icu Medcl, Apotex, Ascent Pharms Inc, Genus Lifesciences, Macleods Pharms Ltd, Pharm Assoc, Sciegen Pharms Inc, Taro, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Pharmobedient, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, and Novartis, and is included in one hundred and thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for potassium chloride. Eighty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for POTASSIUM CHLORIDE

US Patents:	0
Tradenames:	45
Applicants:	64
NDAs:	136
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	85
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6,320
Drug Prices:	Drug price trends for POTASSIUM CHLORIDE
Drug Sales Revenues:	Drug sales revenues for POTASSIUM CHLORIDE
What excipients (inactive ingredients) are in POTASSIUM CHLORIDE?	POTASSIUM CHLORIDE excipients list
DailyMed Link:	POTASSIUM CHLORIDE at DailyMed

See drug prices for POTASSIUM CHLORIDE

See drug sales revenues for POTASSIUM CHLORIDE

Generic filers with tentative approvals for POTASSIUM CHLORIDE

Applicant	Application No.	Strength	Dosage Form
		20MEQ	Tablet; Oral
		10MEQ	Tablet, Extended Release; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for POTASSIUM CHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for POTASSIUM CHLORIDE

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
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

US Patents and Regulatory Information for POTASSIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nesher Pharms	POTASSIUM CHLORIDE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	070980-001	Feb 17, 1987		DISCN	No	No
Pharm Assoc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	210766-002	Mar 29, 2019	AA	RX	No	No
Strides Pharma	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	210733-002	Aug 31, 2018	AB2	RX	No	No
Abraxis Pharm	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	086714-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ascent Pharms Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	211992-002	Apr 9, 2025	AA	RX	No	No
Aurobindo Pharma Ltd	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	214728-002	Mar 31, 2021		DISCN	No	No
Hospira	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	080205-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for POTASSIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982	4,259,315
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	Jun 13, 1986	4,863,743
Apothecon	KLOTRIX	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	017850-001	Approved Prior to Jan 1, 1982	4,140,756
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986	4,863,743
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988	4,259,315
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984	4,259,315

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Potassium Chloride

Last updated: July 27, 2025

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Introduction

Potassium chloride (KCl) stands as a cornerstone in clinical medicine and industry, primarily used as a potassium supplement and in the management of hypokalemia. Additionally, it has applications in food processing, pharmaceuticals, and agriculture. As a pharmaceutical grade, potassium chloride is critical for intravenous therapy, oral supplements, and compounding pharmacies. Understanding the market dynamics and financial trajectory for potassium chloride allows stakeholders—from manufacturers to investors—to make informed decisions amid evolving regulatory, technological, and demand landscapes.

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Market Overview

The global potassium chloride market was valued at approximately USD 13.4 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4.2% through 2030 [1]. Its growth reflects a confluence of factors: rising prevalence of chronic conditions requiring electrolyte correction, expanding agricultural use, and technological advances in manufacturing processes. The pharmaceutical sector accounts for a significant share, driven by increasing incidences of cardiovascular and renal disorders demanding potassium supplementation.

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Supply Chain Dynamics

Raw Material Sources and Production

Potassium chloride is primarily mined from potash deposits, with key producers including Canada, Russia, and Belarus. Canada’s Saskatchewan province hosts one of the world's largest pure potash deposits, contributing notably to global supply. Technological innovations in mining and processing—such as solution mining and flotation techniques—have enhanced yields and purity levels.

Manufacturing and Processing

Pharmaceutical-grade potassium chloride requires stringent quality control, often obtained through processes like recrystallization to eliminate contaminants. The consolidation among key players—such as Nutrien, Mosaic, and Belaruskali—has led to stabilized supply channels but also exposes the market to geopolitical and policy risks.

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Regulatory Environment and Its Impact

Regulatory frameworks significantly influence market dynamics. Agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce strict standards for pharmaceutical-grade potassium chloride. Recent developments include tighter quality control measures post-2020, impacting manufacturing costs and timelines [2].

Furthermore, regulatory shifts toward sustainable mining practices and environmental regulations in key producing countries may constrain or increase supply costs. Import tariffs and export restrictions, especially amid geopolitical tensions, can disrupt supply chains, affecting market stability.

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Demand Drivers

Medical and Pharmaceutical Usage

The global burden of cardiovascular diseases, one of the leading causes of morbidity, drives potassium supplementation needs. Hypokalemia, often arising from diuretic therapy, among other factors, necessitates regular potassium chloride administration. The aging population and increased prevalence of chronic diseases further bolster demand.

Agricultural and Food Industry

Potassium chloride constitutes approximately 95% of the global potash fertilizer market, underpinning agriculture productivity. The World Bank projects global fertilizer consumption to grow alongside food security initiatives, indirectly influencing pharmaceutical-grade potassium chloride demand, especially in countries adopting fortified foods.

Emerging Markets

Rapid urbanization and rising healthcare infrastructure in Asia-Pacific, Africa, and Latin America present new demand opportunities, although price sensitivity remains. Countries like China and India are witnessing increased integration of potassium chloride into both medical and agricultural sectors.

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Market Challenges and Risks

Pricing Volatility

Potassium chloride prices are subject to fluctuations due to raw material supply constraints, geopolitical issues, and global demand swings. The 2021–2022 supply disruptions caused by export restrictions and mine outages led to price surges, impacting procurement costs for pharmaceutical producers [3].

Environmental and Regulatory Challenges

Environmental concerns related to potash mining—such as land degradation and water usage—are prompting stricter regulations. These may result in increased capital and operating costs. Moreover, compliance costs tend to be passed downstream, influencing pharmaceutical manufacturing costs.

Market Competition and Consolidation

High capital requirements favor established players, leading to market consolidation. While this stabilizes supply, it may also limit innovation and create barriers for new entrants, affecting procurement strategies and pricing policies.

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Financial Trajectory and Investment Outlook

Revenue Projections

The pharmaceutical segment of potassium chloride is expected to grow in tandem with global healthcare expenditure, driven by aging demographics and rising chronic illness prevalence. Industry reports estimate pharmaceutical potassium chloride revenues to grow at CAGR of approximately 3.5–4%, aligning with overall market growth.

Profitability and Investment Opportunities

Manufacturers with integrated supply chains and advanced purification technology can maintain higher margins. Vertical integration—combining raw material extraction with processing—reduces vulnerability to raw material price volatility and regulatory changes, favoring sustained profitability.

Emerging markets present demand expansion opportunities, although market entry involves navigating regulatory complexity and price sensitivity. Strategic investments in sustainable mining practices and quality assurance can create competitive advantages.

Potential Disruptors

Advancements in drug delivery systems, such as sustained-release formulations or alternative therapeutic agents, may reduce dependence on potassium chloride, influencing long-term revenues. Additionally, the development of novel electrolyte management therapies, led by biotech innovations, poses potential competition.

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Key Market Trends

• Consolidation among upstream producers stabilizes raw material prices but amplifies geopolitical risks.
• Technological improvements in manufacturing enhance purity and reduce costs, improving the financial outlook.
• Increasing regulatory oversight elevates compliance costs but ensures market quality standards.
• Growing demand in emerging markets offers lucrative opportunities, balanced by price sensitivity.
• Sustainable mining practices are gaining importance, influencing long-term supply chain stability and cost structures.

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Conclusion

The market for pharmaceutical-grade potassium chloride demonstrates robust growth prospects grounded in healthcare, agriculture, and industrial demand. Price volatility and regulatory uncertainties pose challenges but can be mitigated through technological innovation, strategic supply chain management, and geographic diversification. Stakeholders capable of navigating these dynamics are poised to benefit from sustained demand, especially amid demographic shifts and global food security initiatives.

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Key Takeaways

• Market Growth: Expect a steady CAGR of around 4% through 2030, driven mainly by medical and agricultural demand.
• Supply Security: Monopolistic tendencies among key producers and geopolitical risks necessitate diversification strategies.
• Regulatory Impact: Stricter quality and environmental standards will influence manufacturing costs and supply chain stability.
• Investment Opportunities: Vertical integration, innovation, and sustainability initiatives enhance profitability prospects.
• Emerging Markets: Rapid growth in regions like Asia-Pacific offers expansion but requires overcoming price sensitivity and regulatory hurdles.

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FAQs

1. How does geopolitical instability in key potash-producing countries affect the potassium chloride market?
Geopolitical tensions—particularly in Belarus and Russia—can disrupt supply chains, cause price spikes, and introduce import/export restrictions, impacting availability and costs for pharmaceutical manufacturers.

2. What are the primary factors influencing the price of pharmaceutical-grade potassium chloride?
Raw material costs, mining and processing expenses, regulatory compliance, global demand fluctuations, and geopolitical events are primary drivers of price variability.

3. How is environmental regulation impacting potassium chloride supply?
Environmental regulations aim to mitigate mining impacts but can increase operational costs, leading to higher product prices and potential supply limitations.

4. What role do emerging markets play in the future of potassium chloride demand?
Emerging markets contribute significantly to demand growth, driven by expanding healthcare infrastructure, increased agricultural activity, and food fortification initiatives.

5. Are there innovations that could disrupt the market for pharmaceutical potassium chloride?
Yes. Development of alternative electrolyte therapies, improved drug delivery systems, or synthetic substitutes could diminish reliance on potassium chloride in medicine, affecting long-term demand.

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Sources:
[1] MarketWatch, "Global Potassium Chloride Market Size and Forecast," 2023.
[2] FDA Regulations on Pharmaceutical Raw Materials, 2022.
[3] International Fertilizer Industry Review, 2022.