Last Updated: May 13, 2026

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER is amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.

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  • What is the 5 year forecast for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER?
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  • What is Average Wholesale Price for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER?
Summary for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% 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
Baxter Hlthcare TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020147-006 Oct 23, 1995 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 TRAVASOL 4.25% Sulfite-Free with Electrolytes in Dextrose 5% (Plastic Container)

Last updated: February 13, 2026

Market Overview

TRAVASOL 4.25% is an intravenous (IV) solution used for fluid replacement and electrolyte management. Its sulfite-free formulation and inclusion of electrolytes in dextrose 5% position it within the parenteral nutrition and hydration market, mainly in hospitals and clinics. The primary market drivers include the rising prevalence of dehydration, malnutrition, and the increasing need for stable and compatible IV fluids during surgeries and intensive care.

Key Market Factors

1. Market Size and Growth

  • The global IV fluid market was valued at approximately USD 11.5 billion in 2021.
  • Expected compound annual growth rate (CAGR) of 6.2% from 2022–2027 (source: Grand View Research).
  • The neonatal and pediatric segment shows heightened demand for sulfite-free, electrolyte-balanced solutions due to sensitivity concerns.

2. Regulatory Environment

  • The U.S. FDA, EMA, and other agencies uphold stringent standards for IV fluids. Sulfite-free formulations are preferred due to allergy concerns.
  • Approval process for new formulations involves demonstrating safety, stability, and compatibility.

3. Competitive Landscape

  • Major competitors include Baxter's Normosol-R, B. Braun’s Sterofundin ISO, and Fresenius Kabi’s Plasma-Lyte series.
  • TRAVASOL’s differentiators are its sulfite-free status and electrolyte composition tailored for specific patient needs.

4. Manufacturing and Supply Chain

  • Packaging in plastic containers ensures sterile storage and ease of handling.
  • Supply chain challenges include sourcing high-quality electrolytes and maintaining cold chain logistics where necessary.

Financial Trajectory

1. Revenue Projections

  • Based on market share estimates, TRAVASOL’s potential revenue could range between USD 200-300 million globally over the next five years, assuming a modest market penetration of 2-3%.
  • Growth rates hinge on hospital adoption, regulatory approval in new markets, and expanding indications.

2. Pricing Strategy

  • Average wholesale price (AWP) of similar IV fluids ranges from USD 2 to 5 per unit (1000 mL).
  • TRAVASOL’s pricing is expected in this band, with premium for sulfite-free formulations.

3. R&D and Regulatory Spending

  • Development costs estimated at USD 10-20 million per new formulation approval.
  • Regulatory submissions in the U.S. require preclinical, stability, and clinical data, especially for electrolyte stability and compatibility.

4. Market Penetration and Adoption

  • Adoption rate driven by hospital protocols favoring sulfite-free, electrolyte-balanced solutions.
  • Key barriers include existing supplier contracts and procurement cycles.

Strategic Opportunities and Risks

Opportunities

  • Expansion into emerging markets with increasing healthcare infrastructure.
  • Development of specialized formulations for pediatric and neonate use.
  • Partnerships with healthcare providers for bundled procurement.

Risks

  • Regulatory delays or reclassification affecting market access.
  • Competitive pricing pressures.
  • Supply chain disruptions impacting production and distribution.

Summary

TRAVASOL 4.25% sulfite-free with electrolytes in dextrose 5% has a niche within the IV solution market, with growth driven by clinical needs and safety profiles. Financial growth depends on targeted market entry strategies, regulatory approval timing, and competitive positioning. The overall outlook indicates a steady expansion, contingent on healthcare infrastructure development and product differentiation.


Key Takeaways

  • The IV fluid market is expanding at approximately 6.2% CAGR through 2027.
  • TRAVASOL’s sulfite-free, electrolyte-enhanced formulation targets hospital spaces with specific safety needs.
  • Revenue projections suggest USD 200-300 million over five years with strategic market penetration.
  • Pricing aligns with existing premium IV solutions, with potential for volume-based discounts.
  • Regulatory approval and supply chain stability remain critical success factors.

FAQs

1. How does TRAVASOL compare to competing IV fluids in terms of safety?
TRAVASOL’s sulfite-free formulation reduces allergy risks associated with sulfite preservatives, making it suitable for sensitive patient populations.

2. What markets offer the highest potential for growth?
Hospitals in North America, Europe, and emerging markets with growing healthcare infrastructure are prime targets.

3. What regulatory challenges could impact market entry?
Variations in approval timelines, particularly for pediatric formulations or new electrolyte combinations, could delay commercialization.

4. How important is pricing in TRAVASOL’s market success?
Pricing must balance profitability with hospital procurement policies. Competitive positioning is vital for adoption.

5. What are the main risks to TRAVASOL’s financial trajectory?
Market penetration obstacles, regulatory hurdles, and supply chain disruptions pose the primary risks.


References

  1. Grand View Research. IV Fluid Market Size, Share & Trends Analysis Report, 2022–2027.
  2. U.S. FDA Drug Approvals. 2023.
  3. MarketWatch. IV Solutions Industry Overview, 2022.
  4. B. Braun. Sterofundin ISO Product Profile.
  5. Baxter. Normosol-R Product Data Sheet.

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