POTASSIUM CHLORIDE Drug Patent Profile

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

Potassium Chloride is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Endo Operations, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Ajenat Pharms, Amneal, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus Pharms, Pharma Serve Ny, Watson Labs, Anda Repository, Apotex, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Macleods Pharms Ltd, Mylan, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Icu Medical Inc, and Nexus. and is included in one hundred and thirty-one NDAs.

The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.

Summary for POTASSIUM CHLORIDE

US Patents:	0
Applicants:	57
NDAs:	131
Finished Product Suppliers / Packagers:	79
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	2,373
Drug Prices:	Drug price information 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

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
B Braun	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	019630-036	Feb 17, 1988		RX	No	No
B Braun	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	019630-047	Feb 17, 1988		RX	No	No
Miles	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	080195-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sciegen Pharms Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	211648-001	May 21, 2021	AA	RX	No	No
Nexus	POTASSIUM CHLORIDE 20MEQ	potassium chloride	INJECTABLE;INJECTION	214727-004	Mar 18, 2021	AP	RX	No	No

Expired US Patents for POTASSIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986	4,863,743
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	Jun 13, 1986	4,863,743

International Patents for POTASSIUM CHLORIDE

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

Country	Patent Number	Title	Estimated Expiration
Austria	52918
Finland	864207
Greece	860479	CONTROLLED RELEASE POTASSIUM CHLORIDE
South Africa	8601242
Spain	8801121

Supplementary Protection Certificates for POTASSIUM CHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
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

Potassium Chloride Market Dynamics and Financial Trajectory

Introduction

Potassium chloride, a crucial compound in various industries, including pharmaceuticals, agriculture, and industrial applications, has seen significant market dynamics over the years. This article delves into the current market situation, growth drivers, challenges, and the financial trajectory of potassium chloride, particularly focusing on its pharmaceutical grade.

Global Market Overview

The global potassium chloride market is diverse and expansive, with applications spanning multiple sectors.

Market Size and Growth

As of 2024, the global Pharma Grade Potassium Chloride market is estimated to be worth US$ 15 million and is projected to grow to US$ 22 million by 2032, with a Compound Annual Growth Rate (CAGR) of 6.5% during the review period[1].

For the broader potassium chloride market, it is expected to reach US$ 133.50 billion by 2030, growing at a CAGR of 10.50% from 2024 to 2030[3].

Regional Outlook

Europe is the largest production area for pharma-grade potassium chloride, accounting for about 30% of the global market, followed by China and the rest of Asia, which together hold over 50% of the market share[1].

In the United States, the potassium chloride market holds a significant share, particularly in the North America industry, with the U.S. market accounting for 86.1% of the region's industry. China is also a major player, with its market expected to grow at a CAGR of 8.9% from 2020 to 2027[4].

Applications of Potassium Chloride

Pharmaceutical Sector

In the pharmaceutical sector, potassium chloride is used in various forms, including injectable solutions and hemodialysis solutions. It is a critical component in the formulation of certain medications and medical treatments. The pharmaceutical application segment was the leading segment in 2023, accounting for a significant market share[1].

Agricultural Sector

Potassium chloride is widely used as a fertilizer to improve soil fertility and enhance crop yields. The increasing demand for food due to a growing global population is driving the use of potassium chloride in agriculture. This sector is projected to record a 6.1% CAGR from 2020 to 2027[2].

Industrial Sector

The industrial sector, including applications in oil & gas, water treatment, and food processing, also contributes significantly to the demand for potassium chloride. The trend of using potassium chloride as feedstock raw materials is an additional factor driving market growth[3].

Market Drivers

Increasing Demand in Fertilizers

The increasing adoption of potassium chloride in fertilizers is a key factor driving the growth of the global market. This is due to its essential role in improving soil fertility and enhancing crop yields[3].

Pharmaceutical and Medical Applications

The demand for potassium chloride in pharmaceuticals, particularly for injectable solutions and hemodialysis, continues to drive market growth. For instance, high-purity pharmaceutical salts played a crucial role in the administration of coronavirus vaccines during the pandemic[5].

Industrial Expansion

Industrial expansion, especially in countries like China, is boosting the demand for potassium chloride in sectors such as water treatment, food processing, and oil & gas[4].

Market Constraints and Challenges

Economic Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global potassium chloride market, leading to a readjustment in market size and growth projections. Despite this, the market is expected to recover and grow steadily in the post-pandemic period[1].

Price Volatility

One of the key factors hindering the growth of the global potassium chloride market is the shifting prices of potassium chloride. This volatility can affect production costs and profitability for manufacturers[3].

Competition

The market is fairly consolidated but is expected to see fragmentation as emerging players try to capitalize on opportunities. This competition, especially in regions like China, can be fierce and challenging for market participants[4].

Key Players

Major players in the potassium chloride market include ICL (ICL-IP), K+S, and Morton. These companies have a significant presence in the global market and are involved in various strategic initiatives to maintain their market share and competitiveness[1].

Financial Performance and Outlook

Revenue Projections

The global potassium chloride market is projected to reach significant revenue milestones. For instance, the broader market is expected to reach US$ 133.50 billion by 2030, while the pharma-grade segment is forecasted to reach US$ 22 million by 2032[1][3].

Cost Optimization

Companies like K+S are focusing on cost optimization and efficiency improvements. For example, K+S generated more than €150 million from synergies in procurement, logistics, production, and sales and marketing, and reduced the average cost of potash production to less than €200 per tonne[5].

Strategic Initiatives

Key players are engaging in strategic initiatives such as production facility expansions, acquisitions, and joint ventures to enhance their market position. K+S, for instance, sold its Americas operating unit and incorporated its waste management business into a joint venture to streamline operations and reduce costs[5].

Regional Market Dynamics

United States

The United States is a prominent producer and consumer of potassium chloride, with the market driven by its use in agriculture, pharmaceuticals, water treatment, and food processing. The U.S. market holds an 86.1% share in the North America industry[4].

China

China is expected to be the dominant market for potassium chloride in Asia from 2023 to 2033. The country's focus on industrial expansion, particularly in sectors like water treatment, food processing, and agriculture, is driving the demand for potassium chloride[4].

Europe

Europe, particularly Germany, is forecast to grow at a CAGR of approximately 3.8% from 2020 to 2027. The region is a significant production hub for pharma-grade potassium chloride[2].

Conclusion

The potassium chloride market, especially the pharma-grade segment, is poised for steady growth driven by increasing demand in fertilizers, pharmaceutical applications, and industrial expansion. Despite challenges such as price volatility and competition, key players are implementing strategic initiatives to maintain market share and drive growth.

Key Takeaways

• The global pharma-grade potassium chloride market is expected to grow at a CAGR of 6.5% from 2024 to 2032.
• The broader potassium chloride market is projected to reach US$ 133.50 billion by 2030.
• Key applications include pharmaceuticals, agriculture, and industrial sectors.
• Major players are focusing on cost optimization and strategic initiatives to enhance market position.
• Regional markets such as the United States, China, and Europe are significant contributors to the global market.

FAQs

Q: What is the projected market size of the global pharma-grade potassium chloride market by 2032?

A: The global pharma-grade potassium chloride market is forecasted to reach US$ 22 million by 2032[1].

Q: Which region is the largest production area for pharma-grade potassium chloride?

A: Europe is the largest production area for pharma-grade potassium chloride, accounting for about 30% of the global market[1].

Q: What are the primary drivers of the global potassium chloride market?

A: The primary drivers include increasing adoption in fertilizers, demand from pharmaceutical and medical applications, and industrial expansion[3].

Q: How has the COVID-19 pandemic affected the potassium chloride market?

A: The pandemic led to a readjustment in market size and growth projections, but the market is expected to recover and grow steadily in the post-pandemic period[1].

Q: Who are the major players in the potassium chloride market?

A: Major players include ICL (ICL-IP), K+S, and Morton[1].

Sources

1. Pharma Grade Potassium Chloride Market Dynamics till 2032 | Growth Drivers, Market Constraints and Challenges - News Channel Nebraska
2. Global Potassium Chloride Industry (2020 to 2027) - Market Trajectory & Analytics - Business Wire
3. Potassium Chloride Market - Global Analysis and Forecast - Maximize Market Research
4. Potassium Chloride Market Size, Growth, Trend & Share | 2033 - Future Market Insights
5. Annual Report 2020 - K+S Aktiengesellschaft - K+S Aktiengesellschaft