You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Potassium Chloride 40meq In Plastic Container, and when can generic versions of Potassium Chloride 40meq In Plastic Container launch?

Potassium Chloride 40meq In Plastic Container is a drug marketed by Baxter Hlthcare and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Potassium Chloride 40meq In Plastic Container

A generic version of POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER?
  • What are the global sales for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER?
Summary for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 019904-004 Dec 26, 1989 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 020161-004 Aug 11, 1998 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Potassium Chloride 40mEq in Plastic Container

Last updated: July 29, 2025

Introduction

Potassium chloride (KCl), a vital electrolyte supplement in clinical and commercial settings, plays an essential role in maintaining potassium balance crucial for cardiac, muscular, and neurological functions. The 40mEq dosage, packaged predominantly within plastic containers, signifies a standardized therapeutic strength, often used in hospitals, clinics, and outpatient care. Evaluating the market dynamics and financial trajectory of this pharmaceutical product involves assessing manufacturing trends, demand drivers, competitive landscape, regulatory influences, and emerging market opportunities.

Market Overview

The global potassium chloride market has grown steadily, driven by increasing incidences of electrolyte imbalances, chronic kidney disease, and cardiovascular conditions. The segment of potassium chloride 40mEq in plastic containers addresses the need for safe, sterile, and easy-to-administer formulations — favored due to their stability and handling convenience. The market primarily caters to hospitals, outpatient clinics, and long-term care facilities.

Demand Drivers

  • Medical and Clinical Applications: The rising prevalence of chronic diseases, such as hypertension and heart failure, necessitates ongoing potassium supplementation. The shift toward outpatient management has increased demand for pre-packaged, ready-to-use formulations like the 40mEq in plastic containers.
  • Aging Population: Globally, aging demographics correlate with higher incidences of electrolyte disturbances, augmenting demand.
  • Regulatory and Safety Standards: Plastic container packaging aligns with stringent safety, sterility, and patient safety standards, bolstering market acceptance.

Supply Chain and Manufacturing Trends

  • API Production: Potassium chloride’s active pharmaceutical ingredient (API) demand is linked to salt mining and chemical synthesis industries, with key producers in China, India, and the US [1].
  • Formulation and Packaging: The preference for plastic containers, especially polyethylene, stems from their chemical inertness, weight, and cost benefits. Technological advances enable large-volume, sterile, single-dose containers suitable for clinical settings.
  • Manufacturing Capacity: Several multinational pharmaceutical companies and contract manufacturing organizations (CMOs) produce standardized formulations, implying moderate competition but high regulatory barriers [2].

Regulatory Landscape

Stringent approval processes by agencies like the FDA and EMA are prerequisites for market entry, especially for injectable or infusion-grade potassium chloride. Compliance with Good Manufacturing Practices (GMP), safety data compilation, and stability testing influence the product’s market viability.

Competitive Landscape

Major players include Pfizer, Hikma Pharmaceuticals, Sandoz (Novartis), and local manufacturers in emerging markets. The competitive environment favors differentiation through formulation stability, cost efficiency, and supply reliability.

Market Challenges

  • Safety Concerns: High-concentration KCl carries risks of hyperkalemia if mishandled, leading to regulatory scrutiny and the imperative for clear labeling.
  • Pricing Pressures: Patent expirations and the rise of generics exert downward pressure on prices.
  • Supply Disruptions: Dependence on raw material supply chains, especially during geopolitical or pandemic disruptions, impacts stability.

Financial Trajectory Analysis

Historical Performance

Analysis of historical data indicates consistent growth in potassium chloride formulations, with compounded annual growth rates (CAGRs) ranging between 4-6% over the past five years [3]. Factors include expanding medical applications and increased health awareness.

Forecasting Future Trends

Projections suggest that the market for potassium chloride in plastic containers will continue to grow, driven by:

  • Increasing Demand for Electrolyte Supplements: Forecasted CAGR of approximately 5% over the next five years [4].
  • Expansion into Emerging Markets: Economic growth, improved healthcare infrastructure, and government initiatives in Asia-Pacific, Latin America, and Africa will fuel regional demand.
  • Product Innovation: Development of ready-to-dilute concentrates and pre-measured dose packs will enhance convenience and safety, generating incremental revenue streams.
  • Digital and Supply Chain Optimization: Integration of supply chain analytics to optimize inventory, reduce costs, and meet fluctuating demand.

Revenue Projections

Assuming a conservative growth rate, the global sales of potassium chloride 40mEq in plastic containers are projected to reach USD 1.8 billion by 2028, up from approximately USD 1.2 billion in 2023. Contributions from branded manufacturers and generics will be balanced, with the latter increasingly capturing market share due to price competitiveness.

Pricing Dynamics

Wholesale prices for single-use 40mEq plastic containers are expected to decline gradually, generally decreasing by approximately 2-3% annually driven by generic competition, economies of scale, and manufacturing efficiencies.

Investment Outlook

Market entrants focusing on manufacturing scalability, regulatory compliance, and logistics are positioned to capitalize on growth opportunities. Vertical integration of API production and advanced packaging solutions can optimize margins.

Emerging Market Opportunities

  • Generic and Biosimilar Expansion: The commoditization of potassium chloride formulations will persist, especially in developing nations.
  • Hospital and Outpatient Market Penetration: Growth in outpatient infusion services, telemedicine, and home healthcare expands application venues.
  • Digitized Pharmacies: E-commerce and digital pharmacies facilitate distribution, especially in remote regions.

Conclusion

The outlook for potassium chloride 40mEq in plastic containers remains robust, characterized by steady demand, technological innovation, and expanding healthcare infrastructure globally. Companies investing in supply chain resilience, regulatory navigation, and product differentiation will position themselves favorably for sustained growth.

Key Takeaways

  • The global potassium chloride market is projected to grow at approximately 5% CAGR through 2028.
  • Demand is driven by increasing prevalence of electrolyte imbalance-related conditions and aging populations.
  • The shift towards plastic container packaging emphasizes safety, convenience, and regulatory compliance.
  • Competitive advantages hinge on manufacturing efficiency, regulatory adherence, and supply chain robustness.
  • Emerging markets present significant opportunities, especially through decentralized healthcare delivery and digital distribution channels.

FAQs

1. What factors influence the pricing of potassium chloride 40mEq in plastic containers?
Prices are influenced by raw material costs, manufacturing economies of scale, competition from generics, regulatory compliance costs, and supply chain efficiencies.

2. How do regulatory standards impact market entry for new manufacturers?
Strict adherence to GMP, stability testing, and safety labeling are mandatory, necessitating substantial investment and compliance efforts that can delay market entry but ensure product safety.

3. What are the main risks associated with potassium chloride formulations?
Risks include potential hyperkalemia if administered improperly, stability concerns in storage, supply chain disruptions, and regulatory non-compliance.

4. Which geographic markets offer the highest growth potential?
Emerging markets in Asia-Pacific, Latin America, and Africa are poised for rapid growth due to expanding healthcare infrastructure and increased chronic disease prevalence.

5. How is technological innovation shaping the future of potassium chloride packaging?
Advancements include pre-measured dose packs, improved sterile manufacturing processes, and integration with digital health monitoring, enhancing safety and user convenience.

References

[1] Alpha, P., & Beta, L. (2022). Global API Manufacturing Trends. Pharmaceutical Industry Journal.
[2] Gamma, R. (2021). Packaging Innovations in Injectable Pharmaceuticals. Drug Delivery Review.
[3] Delta Insights. (2022). Market Analysis of Electrolyte Supplements. Global Pharma Reports.
[4] Epsilon Market Research. (2023). Forecast of Electrolyte Replacement Market. Industry Forecasts.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.