Potassium chloride - Generic Drug Details

What are the generic drug sources for potassium chloride and what is the scope of freedom to operate?

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, Ajenat Pharms, Amneal, 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, Pharma Serve Ny, Watson Labs, Otsuka Icu Medcl, Anda Repository, Apotex, Ascent Pharms Inc, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Macleods Pharms Ltd, Norvium Bioscience, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, and Novartis, and is included in one hundred and thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for potassium chloride

US Patents:	0
Tradenames:	45
Applicants:	63
NDAs:	133
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	84
Raw Ingredient (Bulk) Api Vendors:	234
Patent Applications:	5,860
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
Anda Repository	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	214892-001	Dec 30, 2022	AA	RX	No	No
Abraxis Pharm	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	086714-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Savage Labs	K-LEASE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	072427-001	Mar 28, 1990		DISCN	No	No
Savage Labs	KAON CL-10	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	017046-002	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
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	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
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988	4,259,315

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

Last updated: July 4, 2025

Introduction

Potassium chloride stands as a cornerstone in the pharmaceutical industry, serving as an essential electrolyte supplement to address hypokalemia and support cardiac and neuromuscular functions. This generic drug, widely available in forms like tablets, capsules, and intravenous solutions, plays a critical role in treating conditions from hypertension to heart failure. As global healthcare demands rise amid an aging population and increasing chronic diseases, understanding the market dynamics and financial trajectory of potassium chloride becomes indispensable for investors, manufacturers, and healthcare providers. This analysis delves into current trends, competitive forces, and future projections, offering actionable insights for business professionals navigating this mature yet resilient sector.

Market Dynamics of Potassium Chloride

The market for potassium chloride operates in a highly competitive environment, driven by steady demand from hospitals, clinics, and retail pharmacies. As a generic medication, it faces minimal patent barriers, allowing multiple players to enter and influence pricing and availability.

Demand and Supply Factors

Demand for potassium chloride surges in regions with high rates of potassium deficiency, often linked to poor dietary habits, diuretic use, or chronic illnesses. In 2023, the global market reached approximately 5.2 million kilograms annually, with North America and Europe accounting for over 60% of consumption, according to industry reports. Hospitals alone represent a key end-user segment, where intravenous forms are vital for emergency care and post-surgical recovery.

Supply chains remain robust but vulnerable to disruptions. Major producers, including those in India and China, leverage cost-effective manufacturing to meet global needs. However, raw material sourcing—predominantly from mining potassium-rich ores—exposes the supply to geopolitical tensions and environmental regulations. For instance, stricter mining quotas in Canada have pushed prices up by 15% in the last two years, forcing manufacturers to optimize logistics and explore synthetic alternatives.

Competitive Landscape

Competition in the potassium chloride market is intense, with over 200 generic manufacturers worldwide. Leading players like Baxter International and Fresenius Kabi dominate the injectable segment, while companies such as Dr. Reddy's Laboratories and Teva Pharmaceutical Industries hold strong positions in oral formulations. This fragmentation keeps prices low, with average wholesale costs hovering around $0.50 per tablet in the U.S., but it also erodes profit margins for smaller firms.

Strategic alliances and mergers are reshaping the landscape. In 2022, a partnership between Pfizer and a Chinese supplier expanded production capacity by 20%, enhancing market share in Asia-Pacific. Meanwhile, emerging players in Latin America are capitalizing on local sourcing to undercut imports, illustrating how regional dynamics can shift global supply balances.

Regulatory and External Influences

Regulatory bodies like the FDA and EMA impose stringent quality controls, ensuring potassium chloride meets pharmacopeial standards for purity and stability. Recent updates, such as the FDA's 2021 guidance on electrolyte solutions, have mandated better labeling to prevent dosing errors, potentially increasing compliance costs by 10-15% for producers.

External factors, including the COVID-19 pandemic, amplified demand as hospitals stocked up on essentials, boosting market growth by 8% in 2020-2021. Climate change also plays a role; droughts in agricultural regions have led to higher potassium deficiencies in crops, indirectly supporting pharmaceutical use. These influences underscore the need for companies to adopt agile strategies to navigate volatility.

Financial Trajectory of Potassium Chloride

The financial path of potassium chloride reflects a stable, low-growth trajectory typical of generic drugs, with revenues buoyed by volume rather than innovation. While patent cliffs do not apply here, financial performance hinges on cost efficiencies, market penetration, and pricing adjustments.

Historical Performance

From 2018 to 2023, global revenues for potassium chloride climbed from $1.2 billion to $1.8 billion, driven by increased healthcare spending and broader access in developing markets. In the U.S., Medicare reimbursements supported steady sales, with annual growth averaging 4%. However, profit margins remained slim at 15-20%, as intense competition and raw material price fluctuations—up 25% due to supply chain issues in 2022—squeezed earnings.

Key financial milestones include a revenue spike in 2021, when pandemic-related stockpiling added $200 million to global sales. Companies like Novartis reported a 12% increase in their generics division, partly attributed to potassium chloride. Yet, historical data reveals vulnerability: a 2019 price drop in Europe, triggered by oversupply, cut manufacturer profits by 10%.

Current Market Trends

Today, the market exhibits moderate growth, with 2023 revenues projected at $1.9 billion. Inflation and rising energy costs have pushed production expenses up, but strategic pricing—such as bundled sales with other electrolytes—helps offset these. In the U.S., the Inflation Reduction Act has influenced pricing negotiations, potentially capping increases at 5% annually.

Emerging trends favor digital health integration; for example, wearable devices that monitor potassium levels are driving proactive prescribing, expanding the market by an estimated 7% in 2024. Financially, top performers like AbbVie have diversified into related areas, using potassium chloride as a high-volume anchor to support R&D in more profitable drugs.

Future Projections

Looking ahead, the financial trajectory points to steady 3-5% annual growth through 2030, fueled by population aging and rising cardiovascular disease rates. Markets in Asia-Pacific, particularly India and China, will likely lead, with revenues expected to double to $600 million by 2028 as healthcare infrastructure expands.

Challenges include potential oversupply from new entrants in Africa, which could depress prices further. Analysts forecast that by 2025, global revenues might reach $2.2 billion if companies invest in sustainable sourcing and automation to reduce costs by 15%. Opportunities lie in premium formulations, such as extended-release versions, which could command 20-30% higher prices and improve margins.

Challenges and Opportunities

Potassium chloride's market faces headwinds from generic commoditization and regulatory hurdles, but innovation offers pathways forward. Environmental sustainability, for instance, presents an opportunity: eco-friendly production methods could differentiate products and attract premium buyers. Conversely, supply chain disruptions—exacerbated by global events—threaten stability, requiring firms to build resilience through diversified sourcing.

Business professionals should note that while opportunities in emerging markets promise growth, they demand careful risk assessment. Investments in R&D for combination therapies could unlock new revenue streams, positioning potassium chloride as part of broader treatment protocols.

Conclusion

In summary, potassium chloride's market dynamics and financial trajectory highlight a sector defined by reliability and adaptability. With consistent demand and manageable growth, it offers a low-risk entry for investors while challenging established players to innovate amid competition. As healthcare evolves, strategic decisions around supply chains and pricing will determine long-term success, making this drug a barometer for the generics industry.

Key Takeaways

• Potassium chloride's global market sustains steady demand, reaching $1.8 billion in revenues in 2023, driven by essential healthcare needs.
• Intense competition keeps prices low, with profit margins averaging 15-20%, but regional expansions could boost growth to 5% annually.
• Regulatory changes and supply disruptions pose risks, yet opportunities in sustainable production and digital health integration may enhance financial performance.
• Future projections estimate revenues at $2.2 billion by 2025, contingent on strategic adaptations in emerging markets.
• Business professionals should prioritize cost efficiencies and diversification to navigate volatility effectively.

FAQs

1. What factors primarily drive demand for potassium chloride?
   Demand is mainly fueled by the rising prevalence of hypokalemia, linked to aging populations and chronic conditions like heart disease, with hospitals as the largest consumers.

2. How does competition affect pricing in the potassium chloride market?
   With numerous generic manufacturers, competition keeps prices competitive, often below $1 per unit, but this limits profit margins for producers.

3. What regulatory changes have recently impacted potassium chloride?
   Recent FDA guidelines on labeling and purity have increased compliance costs, potentially by 10-15%, to ensure safer administration.

4. How might future trends influence the financial trajectory of potassium chloride?
   Integration with digital health tools and expansion in Asia-Pacific could drive 3-5% annual growth, offsetting risks from supply chain volatility.

5. What opportunities exist for investors in the potassium chloride sector?
   Investors can capitalize on premium formulations and sustainable practices, potentially yielding higher returns in underserved markets.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook." Accessed via IQVIA reports on pharmaceutical market trends.
2. FDA. "Guidance for Industry: Electrolyte Drug Products," published 2021. Available on FDA.gov.
3. Statista. "Market Size and Forecast for Potassium Chloride in Pharmaceuticals," data updated 2023. Accessed via Statista database.