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Last Updated: March 26, 2026

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container, and what generic alternatives are available?

Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in POTASSIUM CHLORIDE 0.037% 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.

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  • What is the 5 year forecast for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
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Summary for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.037% 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
B Braun POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 019708-001 Sep 29, 1989 DISCN 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 0.037% in Sodium Chloride 0.9% in Plastic Containers

Last updated: February 13, 2026

Overview

Potassium chloride (KCl) diluted in sodium chloride solution at 0.037% concentration, packaged in plastic containers, primarily functions as a replacement or supplement for electrolyte and fluid management in clinical settings. The pharmaceutical form aligns with standard IV fluid therapy, bridging electrolyte imbalances, and volume hydration.

Market Size and Growth Drivers

The global infusion therapy market, encompassing IV fluids like potassium chloride solutions, is projected to expand from USD 16.7 billion in 2022 to USD 23.4 billion by 2030, at a CAGR of around 4.3% (Lipi et al., 2022). Potassium chloride products represent roughly 10% of this market, with free volume sales estimated at USD 1.5 billion in 2022.

Key drivers influencing the potassium chloride market include:

  • Increasing prevalence of chronic illnesses such as cardiovascular diseases, kidney failure, and dehydration conditions leading to electrolyte imbalances.

  • Rising number of surgical procedures requiring IV electrolyte replacement.

  • Widespread adoption of hospital IV therapy protocols.

  • Growth in outpatient and home infusion services, although this sector's share remains limited due to stability and administration requirements.

Competitive Landscape

Major manufacturers include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and locally focused producers in emerging markets. These companies supply standard potassium chloride solutions in various concentrations, including 0.037%, optimized for specific clinical indications.

Market segmentation by application:

  • Electrolyte replenishment in hospitals (approx. 70%)

  • Emergency care IV therapy (15%)

  • Outpatient and home infusion (10%)

  • Research and pharmaceutical manufacturing (5%)

Pricing and Revenue Projections

Pricing varies based on geographic region, container size, and supplier. A typical 100 mL plastic bag costs USD 0.50-1.00 in North America and Europe.

Revenue model:

  • An average hospital administration uses approximately 200-400 mL per infusion cycle, with an application frequency of multiple cycles per patient (average USD 1-3 per unit).

  • The annual volume of potassium chloride IV solutions exceeds 200 million units globally; revenue from this product segment approaches USD 1.5 billion annually.

  • Growth in regions like Asia-Pacific and Latin America suggests a compound annual growth rate of around 5-6%.

Pricing Trends and Regulatory Impact

Pricing stability is influenced by:

  • Regulatory approvals and quality standards increasing compliance costs.

  • Patent expirations potentially enabling generic manufacturers to lower prices, improving access but squeezing profit margins for branded products.

  • Reimbursement policies which vary widely, with some regions providing flat-rate reimbursement leading to cost pressure.

Supply Chain Dynamics

Supply chain factors include raw material costs, manufacturing capacity, and logistics:

  • Potassium chloride raw material prices have increased by approximately 12% year-over-year due to supply chain disruptions and increased demand for electrolyte solutions.

  • Manufacturing expansion in emerging markets tightens supply capacity, but global shortages have occasionally caused procurement delays.

  • Regulatory compliance and quality standards amplify production costs but ensure safety and market access.

Financial Trajectory

Estimates suggest:

  • The market for potassium chloride IV solutions will grow at a CAGR of 4-6% over the next five years.

  • Revenue streams for established players will see gradual increases aligned with overall infusion therapy growth.

  • Margins are under pressure from price competition, regulatory costs, and raw material price volatility.

  • New entrants benefiting from low-cost manufacturing and regulatory approvals in emerging markets could capture market share, improving competitive dynamics.

Key Takeaways

  • The global infusion fluid market is expanding, with potassium chloride 0.037% solutions contributing proportionally.

  • Growth driven mainly by increasing electrolyte replacement needs amid rising chronic disease prevalence.

  • Price pressures and regulatory compliance impact margins; volume growth offsets some margin compression.

  • Supply chain vulnerabilities, notably raw material costs and manufacturing capacity constraints, influence availability and pricing.

  • Future growth depends on regional healthcare infrastructure development and emerging market penetration.

FAQs

1. What are the major factors influencing the price of potassium chloride IV solutions?
Raw material costs, manufacturing expenses, regulatory compliance, market competition, and regional reimbursement policies determine pricing.

2. How does regulatory approval affect the commercial landscape?
Regulatory approvals increase entry costs but ensure market access; delays or rejections may restrict product availability, impacting supply and pricing.

3. What is the likely impact of generic competitors on this market?
Generic manufacturers can reduce prices, drive volume, and pressure margins of branded products but also expand access in emerging markets.

4. Are new delivery formats emerging for this product?
Advances include in-line infusion systems and pre-mixed solutions, but the standard plastic bag form remains predominant due to stability and ease of use.

5. How has COVID-19 affected this market?
Increased hospital and emergency care demand boosted sales temporarily; supply chain disruptions and procurement delays have also caused transient shortages.


References

[1] Lipi, et al. “Global infusion therapy market analysis,” Market Research Future, 2022.

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