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, Genus Lifesciences, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Macleods Pharms Ltd, Pharm Assoc, Quagen, Sciegen Pharms, Taro, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, 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-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for POTASSIUM CHLORIDE

US Patents:	1
Tradenames:	45
Applicants:	65
NDAs:	138
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	81
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6,456
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
Novel Labs Inc	POTASSIUM CHLORIDE	potassium chloride	FOR SOLUTION;ORAL	210241-001	Nov 21, 2018	AA	RX	No	No
Tris Pharma Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	214076-002	Jan 26, 2022		DISCN	No	No
B Braun	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	018722-001	Nov 9, 1982		DISCN	No	No
Novel Labs Inc	POTASSIUM CHLORIDE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	204828-002	Aug 16, 2016	AB	RX	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
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984	4,259,315
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986	4,863,743

Market Dynamics and Financial Trajectory for Potassium Chloride

Last updated: February 19, 2026

Potassium chloride (KCl) is predominantly used as a dietary supplement for potassium replenishment and as a fertilizer additive. Its market size, growth drivers, and revenue projections are driven by agriculture, healthcare, and industrial sectors.

Market Overview

The global potassium chloride market was valued at approximately USD 15 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2030, reaching over USD 20 billion [1].

Key sectors influencing the market include:

• Agriculture: Fertilizer applications account for nearly 95% of demand.
• Healthcare: Used as a supplement for hypokalemia treatment.
• Industrial Uses: Variations in industrial demand are limited relative to agriculture and healthcare.

Market Drivers

Agriculture Sector

The increased demand for food production globally fuels fertilizer consumption. Potassium is a critical nutrient for crop yield, soil health, and plant resistance. Governments in emerging markets invest heavily in fertilizer infrastructure, propelling KCl demand.

Healthcare Sector

Rising prevalence of conditions linked to potassium deficiency, such as cardiovascular diseases, boosts demand for KCl-based supplements and infusion solutions. Aging populations in North America and Europe further drive healthcare consumption.

Supply Chain Factors

• Major producers include Canada, Russia, Belarus, and Chile.
• Russia and Belarus account for approximately 35-40% of global exports [2].
• Supply disruptions from geopolitical tensions, sanctions, or weather impact prices and availability.

Market Challenges

• Price volatility due to geopolitical conflicts and weather events.
• Environmental concerns over mining practices and associated emissions.
• Competition from alternative potassium sources like sulfate forms and organic fertilizers.

Financial Trajectory

Revenue Growth

The market's revenue is expected to expand from USD 15 billion in 2022 to approximately USD 20 billion by 2030, representing a CAGR of 4-5%. Growth is primarily driven by fertilizer demand, with healthcare's contribution expanding at a steady pace.

Pricing Trends

The average FOB (Free On Board) price of potassium chloride fluctuated between USD 200-300 per ton in 2022. Price sensitivity to supply disruptions has increased, with spikes reaching USD 350/ton during shortages [3].

Investment Patterns

• Capital expenditure on mining and processing facilities is increasing.
• R&D efforts focus on producing eco-friendlier mining technologies and alternative formulations.

Competitive Landscape

Major players include Nutrien Ltd., Mosaic Company, OCP Group, and Canada-based Nutrien. Consolidation and mergers occur periodically to maintain market share amid price fluctuations.

Future Outlook

The market outlook remains stable with moderate growth. Industry shifts toward sustainable mining and environmentally friendly fertilizer options are expected to shape future investments. Regulatory pressures concerning mining practices could influence supply prices.

Year	Market Value (USD Billion)	CAGR	Notes
2022	15	—	Baseline year
2025	17.5	4-5%	Projected mid-term growth
2030	20	4-5%	Target market size

Key Takeaways

• Potassium chloride's market size exceeds USD 15 billion, with steady growth driven by agriculture and healthcare.
• Supply concentrations in Russia and Belarus create volatility and price sensitivity.
• Prices fluctuate between USD 200-350/ton, influenced by geopolitical and weather factors.
• Major industry players continue to invest in capacity expansion and sustainability initiatives.
• The outlook points to stable growth with emerging environmental regulations affecting supply dynamics.

FAQs

Q1: What are the main uses of potassium chloride?
Primarily used as a fertilizer additive to supply potassium in agriculture and as a potassium supplement in healthcare for treating hypokalemia.

Q2: Which regions are the largest consumers of potassium chloride?
North America, Europe, and Asia-Pacific. Europe and North America see increased healthcare demand; Asia-Pacific leads in fertilizer consumption.

Q3: How do geopolitical tensions affect the market?
Tensions involving Russia, Belarus, or other key exporters can reduce supply, increase prices, and create market volatility.

Q4: Are there alternatives to potassium chloride?
Yes; potassium sulfate and organic fertilizers can replace KCl, but they are often more expensive or less efficient in certain applications.

Q5: What are environmental concerns related to potassium chloride mining?
Mining can cause land degradation, water contamination, and emissions. Regulatory pressures are pushing for more sustainable practices.

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References

[1] Markets and Markets. (2023). Potassium chloride market report.
[2] US Geological Survey. (2022). Mineral commodity summaries: Potassium.
[3] ICIS. (2022). Potassium chloride price analysis.