Last Updated: August 2, 2026

POTASSIUM CHLORIDE 40MEQ Drug Patent Profile


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Which patents cover Potassium Chloride 40meq, and what generic alternatives are available?

Potassium Chloride 40meq is a drug marketed by Fresenius Kabi Usa, Nexus, Baxter Hlthcare, Otsuka Icu Medcl, and Icu Medical Inc. and is included in sixteen NDAs.

The generic ingredient in POTASSIUM CHLORIDE 40MEQ is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

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Summary for POTASSIUM CHLORIDE 40MEQ
US Patents:0
Applicants:5
NDAs:16

US Patents and Regulatory Information for POTASSIUM CHLORIDE 40MEQ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa POTASSIUM CHLORIDE 40MEQ potassium chloride INJECTABLE;INJECTION 211087-004 Sep 9, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 213523-004 Mar 9, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate INJECTABLE;INJECTION 019685-004 Oct 17, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019691-009 Mar 24, 1988 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008-009 Apr 28, 1982 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 019686-002 Oct 17, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 019904-004 Dec 26, 1989 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 8, 2026

Investment Scenario and Fundamentals Analysis for Potassium Chloride 40 mEq

Overview

Potassium chloride 40 mEq is widely used as a potassium supplement for hypokalemia management. Its market状批稳ely relies on the prevalence of electrolyte imbalances, chronic kidney disease, and cardiovascular conditions. The drug is available in multiple formulations, including oral tablets and intravenous solutions, and is generally off-patent.

Market Landscape

  • Global Demand: The potassium chloride market was valued at approximately $1.8 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 4.2% until 2030.
  • Major Players: Key manufacturers include Mylan, Teva, and Fresenius, with several generic producers licensed to produce the drug due to patent expiry.
  • Pricing Dynamics: Oral formulations typically fetch prices ranging from $0.05 to $0.15 per 10 mEq dose, while IV formulations are priced higher, approximately $0.40 to $1.20 per 40 mEq dose.
  • Regulatory Status: Approved by FDA, EMA, and other major authorities, with no recent significant regulatory barriers.

Key Investment Drivers

  • Increasing Prevalence of Comorbidities: Rising incidences of heart failure, CKD, and use of diuretics heighten demand for potassium supplements.
  • Generic Competition: The patent expiry has led to a highly competitive market, which suppresses margins but maintains high volume.
  • Manufacturing and Supply Chain Stability: Reliable supply chains ensure steady availability; disruptions could impact revenues.
  • Pricing Pressure: Governments and payers push for cost-effective products, limiting price increases, especially in mature markets.
  • Innovation and Formulation Differentiation: Limited innovation exists; most products are commoditized.

Financial Fundamentals

Aspect Details
Revenue Trends Stable but mature; growth driven mainly by volume expansion
Cost Structure Low variable costs, significant fixed costs in manufacturing
Margins Gross margin typically 30-50%; net profit margins stay low due to competition
R&D Investment Minimal; focus on process efficiency and supply chain management
Regulatory & Legal Risks Low; well-established approval pathway, but patent challenges in emerging markets exist

Investment Risks

  • Market Saturation: Limited growth in established markets due to high competition and genericization.
  • Pricing and Reimbursement Policies: Governments controlling prices could compress margins.
  • Regulatory Changes: Potential for altered regulations impacting manufacturing or approval processes.
  • Supply Chain Disruption: Reliability of raw material supply (potassium salts) is critical.

Strategic Positioning

  • Manufacturers should focus on operational efficiency, cost control, and expanding access to emerging markets.
  • Investors should evaluate companies' market share, cost positions, and ability to adapt to pricing pressures.
  • Entrants face high barriers in manufacturing scale and distribution networks, with little room for differentiation.

Conclusion

Potassium chloride 40 mEq presents a stable cash flow opportunity dominated by mature markets. Growth prospects hinge on demographic trends and global health burden, but saturation and price pressures limit margin expansion. It is suitable for investors seeking consistent returns in the generic pharmaceutical segment or established companies aiming to diversify their portfolio.


Key Takeaways

  • Large, mature market with global demand driven by chronic disease prevalence.
  • Highly competitive segment, with limited scope for price increases.
  • Margins remain low, emphasizing operational efficiency over product differentiation.
  • Low R&D expenditure; risk primarily from regulatory and supply chain factors.
  • Favorable for companies with established manufacturing scale and supply chain resilience.

FAQs

1. Can innovation or new formulations significantly impact the market for potassium chloride?
Limited innovation exists; most formulations are standardized. Any new formulations would require regulatory approval and demonstrate clear advantages, which is unlikely in the short term given the mature market status.

2. How do pricing pressures influence investment returns?
Pricing pressures from payers and government agencies suppress profit margins but don't typically halt sales volume, resulting in stable cash flow.

3. Are regulatory risks significant?
Regulatory approval for generics is well-established. Risks mainly involve compliance with evolving quality standards rather than approval delays.

4. What is the impact of emerging markets?
Emerging markets present growth opportunities due to increasing healthcare infrastructure and disease burden but may face challenges with regulatory standards, quality control, and pricing.

5. How does supply chain stability affect valuation?
Stable supply chains lower operational risk, supporting steady revenue streams. Disruptions can lead to shortages, impacting sales and profitability.


Sources

[1] MarketsandMarkets. "Potassium Chloride Market," 2022.
[2] IQVIA. "Global Pharmaceutical Market Trends," 2023.
[3] FDA. "Drug Approvals & Regulatory Information," 2023.

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