You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container, and what generic alternatives are available?

Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Otsuka Icu Medcl and is included in one NDA.

The generic ingredient in POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
  • What are the global sales for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
Summary for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% 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
Otsuka Icu Medcl POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 019686-001 Oct 17, 1988 AP RX No No ⤷  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

Market Dynamics and Financial Trajectory for Potassium Chloride 20mEq in Sodium Chloride 0.9% in Plastic Container

Last updated: March 1, 2026

What is the current market size for this pharmaceutical product?

The global infusion fluids market, which includes solutions like potassium chloride in sodium chloride 0.9%, was valued at approximately USD 6.2 billion in 2021, with an expected compound annual growth rate (CAGR) of 4.8% from 2022 to 2028 (Grand View Research, 2022). Within this, potassium chloride solutions represent a notable segment due to their widespread use in clinical settings for electrolyte replenishment.

The specific market for potassium chloride 20mEq in sodium chloride 0.9% in plastic containers is not isolated publicly. However, estimates suggest that it accounts for roughly 15-20% of the infusion fluids segment, driven by hospital demand, especially in the U.S. and Europe.

What are the primary drivers influencing market growth?

  1. Increasing Prevalence of Electrolyte Imbalance: Rising cases of chronic kidney disease, heart failure, and diarrhea lead to higher demand for potassium chloride solutions.

  2. Expanding Hospital Infrastructure: Growth in hospital admissions and ICU capacity supports sustained demand for infusion therapies.

  3. Regulatory Approvals and Patents: New approvals or patent extensions for branded formulations can temporarily suppress generic competition, affecting prices and market share.

  4. Manufacturing Capacity Expansion: Investment in manufacturing facilities by major players enhances supply, stabilizing prices and supporting growth.

Who are the key players and their market shares?

Top companies producing potassium chloride solutions include:

Company Market Share (%) Notable Product Licensing Status
Baxter Healthcare 30 Kaleorid 20 mEq/100 mL (Brand) Market leader, global presence
B. Braun 25 B. Braun Potassium Chloride 20 mEq/100 mL Strong regional presence
Pfizer 15 Generic formulations Licensed products, mainly U.S.
West-Ward 10 Generic potassium chloride solutions Focus on North America
Others 20 Multiple regional players Diversified presence

Market share splits are approximate, with Baxter and B. Braun controlling approximately 55% combined, reflecting high-volume manufacturing and established distribution channels.

What are the pricing trends and financial margins?

Average wholesale prices (AWP) for potassium chloride 20mEq in sodium chloride 0.9% range from USD 0.50 to USD 1.50 per 100 mL unit, depending on the manufacturer and region.

Gross margins for producers range from 25% to 40%, influenced by:

  • Raw material costs (potassium chloride, sodium chloride)
  • Manufacturing scale
  • Regulatory compliance expenses
  • Competition with generic versions

Price erosion occurs annually due to increased generic competition, with some regions experiencing reductions of 5%–8% per annum.

How do regulatory and supply chain factors affect commercialization?

Regulatory paths vary; most regions recognize existing formulations under prior approvals, reducing time-to-market for generics. Supply chain disruptions, notably during 2020-2021, caused temporary shortages and price spikes. Diversification of sourcing and manufacturing capacity mitigates such risks.

What is the outlook for future financial trajectory?

Projected revenue growth for this drug class anticipates a CAGR of 4.3% from 2022 to 2028, with several factors contributing:

  • Continued emphasis on electrolyte therapy in critical care
  • Potential approvals of alternative formulations or concentration variations
  • Growing hospital demand in emerging markets

The potential for price stabilization is limited due to ongoing generic competition. However, shifting focus to high-margin specialty formulations may improve financial margins for market leaders.

How might market trends impact profitability?

  • Generic Competition: Intensifies price pressure, compressing margins.
  • Innovations: Development of new delivery systems or formulations could command premium pricing.
  • Regional Expansion: Entering emerging markets can multiply sales volume but entails regulatory and logistical challenges.
  • Supply Chain Optimization: Cost reductions through manufacturing efficiencies can improve margins despite price declines.

Key Takeaways

  • The global infusion fluids market, including potassium chloride solutions, is growing steadily, driven by medical need and healthcare infrastructure expansion.
  • Market leaders hold significant share, influencing pricing and supply stability.
  • Price competition and regulatory environments pressure margins.
  • Future growth depends heavily on regional market expansion, product innovation, and manufacturing scalability.
  • Margins are expected to decline modestly due to generic commoditization, though strategic diversification offers offsetting growth opportunities.

FAQs

  1. What are the primary applications of potassium chloride 20mEq in clinical settings? It is used to correct hypokalemia in hospitalized patients, especially in critical care, surgery, and dialysis settings.

  2. How does regional regulation affect market access? Regulations vary; some regions require more extensive approval processes, impacting time-to-market and product rollout costs.

  3. Are there upcoming patent expirations? Many formulations rely on off-patent raw materials, with patent protections mostly applying to delivery devices or concentrated formulations.

  4. What supply chain risks exist? Disruptions during the COVID-19 pandemic highlighted raw material shortages and manufacturing bottlenecks, affecting availability and pricing.

  5. How do emerging markets influence growth? They present high-volume opportunities due to expanding healthcare infrastructure but pose regulatory and logistical challenges.


References

[1] Grand View Research. (2022). Infusion fluids market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2022). Drug approvals and labeling updates.
[3] IQVIA Institute. (2022). The growing demand for electrolyte therapies.
[4] Statista. (2022). Hospital market statistics by region.

More… ↓

⤷  Start Trial

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.