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Last Updated: December 19, 2025

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% Drug Patent Profile


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Which patents cover Dextrose 5% And Potassium Chloride 0.075%, and when can generic versions of Dextrose 5% And Potassium Chloride 0.075% launch?

Dextrose 5% And Potassium Chloride 0.075% is a drug marketed by Fresenius Kabi Usa, Baxter Hlthcare, and B Braun. and is included in three NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.

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Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
Drug patent expirations by year for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%

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 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride INJECTABLE;INJECTION 212346-001 Sep 10, 2020 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-011 Jan 18, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-004 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-010 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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 Dextrose 5% and Potassium Chloride 0.075%

Last updated: July 27, 2025

Introduction

Dextrose 5% combined with Potassium Chloride 0.075% represents a critical formulation in intravenous (IV) therapy, primarily used to manage electrolyte balance and fluid replenishment in clinical settings. This compound mixture's market dynamics are influenced by factors ranging from medical necessity and regulatory frameworks to technological advancements and global healthcare trends. Analyzing these elements provides insights into the product's financial trajectory and strategic positioning within the pharmaceutical landscape.

Market Overview

Product Profile and Medical Application

Dextrose 5% (D5) serves as a source of glucose, primarily providing calories and maintaining hydration. Potassium Chloride is integral in correcting hypokalemia and managing electrolyte disorders. When combined, these formulations facilitate comprehensive IV therapy, especially in hospitals and emergency care units. Their use extends across pediatric, adult, and specialized care domains, including critical care and postoperative management.

Market Size and Growth Trends

The global market for IV fluids, inclusive of solutions like Dextrose 5% with potassium chloride, was valued at approximately USD 10 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.5%-6% through 2030, fueled by increasing chronic disease prevalence and expanding healthcare infrastructure.

The specific segment for electrolyte solutions, considering the high clinical demand, is anticipated to expand proportionally, contributing a significant share within the overall IV solutions market. The Asia-Pacific region demonstrates the fastest growth, driven by rising healthcare expenditure, strategic infrastructure investments, and increasing regulatory approvals.

Market Drivers

Rising Prevalence of Chronic and Critical Diseases

Chronic conditions such as diabetes, renal diseases, and cardiovascular disorders necessitate frequent and sustained IV therapy, boosting demand for formulations like Dextrose 5% with electrolyte supplements. The global increase in surgical procedures, especially minimally invasive surgeries, also elevates the need for perioperative IV solutions.

Increasing Healthcare Infrastructure and Urbanization in Emerging Markets

Countries such as India, China, and Brazil are expanding healthcare facilities, which enhances the accessibility to critical care products. Government initiatives aimed at bolstering universal healthcare coverage further stimulate demand.

Regulatory Approvals and Technological Innovations

Streamlined approval processes and advancements in sterile manufacturing techniques reduce costs and improve product safety. The adoption of ready-to-use IV solutions enhances quality control and reduces complications, thus boosting market penetration.

Favorable Reimbursement and Cost-Effectiveness

Insurance coverage and government subsidy programs cover IV solutions, reducing out-of-pocket expenses and fostering higher utilization rates, especially in developed nations.

Market Challenges

Stringent Regulatory Landscape

Approval of sterile injectable products requires compliance with rigorous quality standards, which entails substantial R&D investment and regulatory scrutiny. Variability in regulatory requirements across countries can delay market entry.

Pricing Pressures and Generic Competition

The presence of numerous generic manufacturers exerts downward pricing pressure. In mature markets, price erosion can impact profit margins, especially for branded formulations.

Supply Chain Complexities

Ensuring consistent quality and sterility involves sophisticated manufacturing and distribution networks. Disruptions, such as those experienced during the COVID-19 pandemic, can impact availability and revenue streams.

Safety Concerns and Risk of Errors

Misadministration or compounding errors involving electrolyte solutions carry risks of adverse events. Enhanced safety protocols increase operational costs but are necessary to maintain compliance and reputation.

Financial Trajectory and Market Outlook

Revenue Projections and Key Growth Areas

Projected revenue for Dextrose 5% and Potassium Chloride 0.075% formulations is expected to reach USD 12-14 billion globally by 2030, representing a CAGR of approximately 4-6%. Growth will be driven by:

  • Increasing adoption in emerging markets.
  • Expansion of hospital infrastructure and specialized care.
  • Adoption of ready-to-use, pre-filled infusion products.

Manufacturing and Investment Trends

Leading pharmaceutical firms are investing in advanced sterile manufacturing facilities to meet escalating demand. Strategic collaborations with healthcare providers and distributors optimize supply chain efficiency.

Market Segmentation and Pricing Strategies

Premium-priced branded solutions continue to hold market share in developed nations, leveraging quality and safety. Conversely, price-sensitive markets rely heavily on generics, contingent upon local regulatory approval and distribution channels.

Impact of Digitalization and Data Analytics

Integrating digital tracking and inventory management enhances operational efficiency, reduces wastage, and ensures compliance, thus augmenting financial performance.

Regulatory and Policy Impacts

Governmental policies promoting the use of essential medicines and supportive reimbursement frameworks underpin sustained revenue streams. Conversely, regulatory hurdles may delay market entry, constraining growth temporarily.

Competitive Landscape

Major players include:

  • Baxter International
  • Becton Dickinson
  • Fresenius Kabi
  • Hospira (a Pfizer subsidiary)
  • Braun Melsungen

These companies focus on expanding their sterile manufacturing capacities, differentiating products through safety features, and strategic geographies expansion.

Regional Market Dynamics

North America

Dominates due to advanced healthcare infrastructure, high disease prevalence, and comprehensive reimbursement schemes. Market is mature, characterized by high competition among established players.

Europe

Comparable to North America, with increasing emphasis on safety standards and innovations in infusion technology. Regulatory landscape is rigorous, impacting speed to market.

Asia-Pacific

Fastest-growing sector driven by healthcare infrastructure development, population growth, and economic expansion. Companies are investing significantly in local manufacturing and partnerships.

Latin America and Middle East & Africa

Emerging markets with expanding healthcare access; the potential for growth is significant but hindered by regulatory complexities and pricing pressures.

Conclusion: Strategic Considerations

The outlook for Dextrose 5% with Potassium Chloride 0.075% is optimistic, supported by rising healthcare needs and technological advancements. Companies must navigate regulatory challenges, price competition, and supply chain complexities to capitalize on this growth. Innovation in safety, stability, and delivery formats can serve as differentiators, ensuring sustained market share and revenue growth.


Key Takeaways

  • The global IV fluids market, including Dextrose 5% and potassium chloride formulations, is projected to grow at a CAGR of 4.5%-6% through 2030, driven by increasing healthcare infrastructure and chronic disease prevalence.
  • Emerging markets present robust growth opportunities, supported by policy shifts and rising healthcare access.
  • Competition is intense, with price pressures balanced against innovations in safety and delivery.
  • Regulatory compliance and supply chain efficiency are critical success factors.
  • Digital transformation and strategic collaborations will shape future market trajectories.

FAQs

1. What are the primary medical indications for Dextrose 5% combined with Potassium Chloride 0.075%?
Primarily used for fluid replenishment, hydration, and correction of hypokalemia in hospitalized patients, including those undergoing surgery, critical care, or suffering from electrolyte imbalances.

2. How are regulatory frameworks impacting the market for these IV solutions?
Stringent standards for sterility, safety, and labeling influence approval timelines and manufacturing costs. Variability across regions may pose barriers to swift market entry but also create opportunities for differentiated, compliant products.

3. What are the main competitive strategies employed by pharmaceutical companies in this market?
Focus on expanding manufacturing capacity, enhancing safety features, targeting emerging markets, and establishing long-term supply agreements with healthcare providers.

4. How does technological innovation influence the market trajectory?
Advancements such as pre-filled syringes, improved infusion pump compatibility, and real-time safety monitoring enhance product appeal and create barriers to imitation, supporting sustained revenue.

5. What role does healthcare policy play in shaping future growth?
Reimbursement policies, essential medicines listing, and government healthcare initiatives directly influence demand, pricing, and market access, shaping long-term financial outcomes.


Sources:
[1] Transparency Market Research, "IV Fluids Market," 2022.
[2] MarketsandMarkets, "Global IV Solutions Market," 2023.
[3] WHO, "Essential Medicines List," 2021.

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