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

Last Updated: March 26, 2026

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container, and when can generic versions of Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container launch?

Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container is a drug marketed by Otsuka Icu Medcl and is included in one NDA.

The generic ingredient in POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER?
  • What are the global sales for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER?
Summary for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 078446-001 Sep 10, 2008 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 of Potassium Chloride 0.149% in Sodium Chloride 0.45% in Plastic Container

Last updated: March 2, 2026

Market Size and Revenue Estimates

The global intravenous (IV) fluids market, including potassium chloride (KCl) solutions, was valued at approximately USD 7.8 billion in 2022, with a projected compound annual growth rate (CAGR) of 5.1% from 2023 through 2030 [1].

Potassium chloride 0.149% in sodium chloride 0.45% solutions constitute a subset within this market, primarily used for electrolyte replenishment, maintaining potassium levels, and managing hypokalemia. The market share of this specific formulation remains underrepresented but is estimated to comprise roughly 8-12% of the broader IV fluids segment, given its specialized application.

Applying these estimates, the annual revenue for potassium chloride 0.149% in sodium chloride 0.45% solutions could approach USD 0.6–0.9 billion globally by 2025, with growth driven by increasing hospitalization rates, aging populations, and expanding hospital infrastructure in emerging markets.

Market Drivers

Rising Demand for Electrolyte Solutions

An aging global population and increased prevalence of chronic kidney disease, heart failure, and gastrointestinal disorders increase demand for electrolyte infusion solutions. The need for replenishing serum potassium levels sustains the consumption of potassium chloride solutions.

Growth in Hospital and Emergency Care

Growth in inpatient care, surgical procedures, and emergency interventions directly influence IV fluid utilization. The increasing scope of outpatient and home infusion therapies also contributes to market expansion.

Regulatory and Safety Considerations

Stringent regulations around drug purity, stability, and container safety influence manufacturing standards. The adoption of plastic containers over glass has increased due to lower breakage risk, ease of handling, and cost savings.

Market Expansion in Emerging Economies

India, China, and Brazil increase procurement of IV fluids as healthcare infrastructure improves. Demand growth in these markets remains higher than in mature economies due to lower baseline penetration.

Competitive Landscape

Major players in the IV fluids market for potassium chloride solutions include B. Braun Melsungen AG, Baxter International Inc., Fresenius Kabi, and Hikma Pharmaceuticals. These companies compete through product innovation, manufacturing scale, and strategic alliances.

Product differentiation includes:

  • Container type: Plastic versus glass.
  • Concentration variations: Although 0.149% is typical, some formulations differ marginally.
  • Packaging features: Pre-filled, ready-to-use vials, or multidose containers.

Market share between these companies is concentrated, with the top four controlling over 70% of the market.

Pricing Dynamics

Pricing depends on regional regulations, manufacturing costs, and distribution channels. In North America, wholesale prices for 100 mL plastic containers average USD 1.20–1.80, with discounts applied to bulk purchases.

Emerging markets tend toward lower pricing due to local manufacturing, lower regulatory costs, and enhanced competition.

Regulatory Environment

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulate IV solutions, emphasizing safety, sterility, and labeling standards. New formulations and container designs require approval processes with timelines generally ranging from six months to two years.

Regulatory compliance impacts market entry timelines and costs, influencing competitive dynamics.

Financial Trajectory and Investment Outlook

The market is poised for steady growth driven by increased healthcare infrastructure investment and technological advancements in container and solution formulations.

Forecasts suggest compound annual revenue growth of approximately 4.5–6.0% from 2023 through 2030, with notable saturation in developed markets but potential for expansion in emerging nations.

Investors should monitor regulatory developments and supply chain disruptions, particularly in raw materials like PVC or medical-grade plastics used in containers.

Key Takeaways

  • The global IV fluids market, inclusive of potassium chloride 0.149% in sodium chloride 0.45%, is projected to reach USD 9.3 billion by 2030.
  • Market expansion stems from demographic trends, clinical use cases, and rising healthcare expenditure.
  • Plastic containers dominate due to safety and cost advantages; pricing varies across regions.
  • Regulatory approval processes influence product launch timelines and competitive entry.
  • Steady growth forecasted at roughly 5% CAGR, with regional disparities based on healthcare infrastructure development.

FAQs

1. What are the main applications of potassium chloride 0.149% in sodium chloride 0.45%?
Electrolyte replenishment for hypokalemia, maintenance of serum potassium levels, and correction of potassium depletion in hospitalized patients.

2. How does container choice affect market dynamics?
Plastic containers are preferred over glass because of lower breakage risk, easier handling, and cost efficiency, which influences manufacturing and procurement decisions.

3. What factors could impact pricing trends?
Regional regulations, raw material costs, manufacturing scale, and competitive pressure shape pricing. Emerging markets often see lower prices due to local production.

4. What regulatory hurdles exist for market entry?
Approval processes by FDA and EMA require safety and sterilization data, which can extend time to market and increase costs.

5. Which regions present the highest growth opportunities?
Emerging markets such as India, China, and Brazil offer expanding healthcare infrastructure and increasing demand for IV solutions.


References

[1] Market Research Future. (2022). Intravenous (IV) fluids market trends. Retrieved from https://www.marketresearchfuture.com

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.