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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, Endo Operations, Glenmark Pharms Ltd, Granules, Lupin Ltd, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Genus, Amneal, Belcher, Epic Pharma Llc, Novitium Pharma, Rubicon, Kv Pharm, 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, Nexus, Icu Medical Inc, Anda Repository, Apotex, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, 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, and Novartis, and is included in one hundred and thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for potassium chloride. Eighty-seven 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:	132
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	87
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	5,871
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
Sigmapharm Labs Llc	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	207528-001	Aug 19, 2016		DISCN	No	No
Genus Lifesciences	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	206814-002	Dec 22, 2014	AA	RX	Yes	Yes
Chartwell Rx	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	206630-001	Mar 29, 2019		DISCN	No	No
Endo Operations	POTASSIUM CHLORIDE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	202886-002	Dec 26, 2013		DISCN	No	No
Tris Pharma Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	214076-002	Jan 26, 2022		DISCN	No	No
Baxter Hlthcare	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	potassium chloride; sodium chloride	INJECTABLE;INJECTION	017648-004	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
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986	4,863,743
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
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

POTASSIUM CHLORIDE Market Analysis and Financial Projection Experimental

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