Last Updated: July 27, 2026

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER Drug Patent Profile


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When do Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 25% In Plastic Container patents expire, and what generic alternatives are available?

Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 25% 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 25% 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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Summary for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

US Patents and Regulatory Information for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% 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 25% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020147-010 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
Last updated: July 12, 2026

TRAVASOL 4.25% Sulfite Free With Electrolytes in Dextrose 25% in Plastic Container: Market Dynamics and Financial Trajectory

Executive summary: TRAVASOL 4.25% sulfite free w/ electrolytes in dextrose 25% in plastic container is a specialized parenteral nutrition (PN) amino acid/dextrose electrolyte mixture. Demand is anchored to inpatient PN uptake and neonatal/ICU nutrition protocols, with purchasing dominated by IDNs, group purchasing organizations, and hospital pharmacy formularies. Commercial trajectory is shaped less by prescription “new use” economics and more by: (1) institutional contracting and tender cycles, (2) intermittent supply/packaging constraints, (3) payer and hospital budget pressure, and (4) competitive product substitutions across generic PN components or alternative ready-to-use PN regimens.

No complete, decision-grade financial dataset (U.S. FDA product-level revenue, unit volumes, and channel share tied specifically to this exact TRAVASOL pack strength and container format) is available in the provided context, and a full, accurate financial trajectory cannot be produced without that product-specific reporting layer.


Is TRAVASOL 4.25% sulfite free w/ electrolytes in dextrose 25% a growth product or a commodity?

Short answer: It is a contracting-driven hospital commodity within PN, not a branded “trend” product.

TRAVASOL is positioned in PN where formularies favor ready-to-use, standardized mixtures that reduce compounding variability and labor. For amino acid/dextrose/electrolyte admixtures, growth is typically limited by clinical guideline saturation and the core reality that PN is mostly used in defined inpatient populations (post-op, critical care, and patients unable to tolerate enteral nutrition). As a result, “growth” more often comes from share gains through supply reliability and formulary inclusion than from category expansion.

What market forces determine pricing power in hospital PN mixtures?

Pricing power is constrained by:

  • Contracting: Hospital procurement uses tender pricing, multilayer GPO pricing, and “secondary sourcing” expectations.
  • Clinical substitutability: Similar amino acid and dextrose strengths can be substituted by alternate ready-to-use PN mixes or by compounding from PN component kits.
  • Budget scrutiny: PN admixtures are controllable in hospital pharmacy spend; administrators push for lowest-cost equivalent formulations.

Where can revenue still expand?

Revenue can expand when:

  • A hospital switches from compounding to ready-to-use PN for workflow and safety.
  • TRAVASOL becomes the default PN solution in an ICU or neonatal service line.
  • The supplier secures preferred logistics or allocation during shortages (short-lived but high leverage).

What drives hospital demand for 25% dextrose PN with amino acids and electrolytes?

Short answer: ICU and perioperative PN protocols plus institutional adoption of ready-to-use PN regimens.

Demand drivers include:

  • Inpatient acuity: Higher ICU bed utilization tends to lift PN patient-days.
  • Patient mix: Surgical oncology, trauma, and severe malnutrition admissions increase PN use.
  • Neonatal use practices (where applicable): For neonatal PN, electrolyte and amino acid formulations must match clinical standards; product availability matters.
  • Institutional policy: Some hospitals require preprinted PN order sets that default to specific commercially packaged admixtures.

How do shortages and manufacturing capacity affect utilization?

In PN, shortfalls can be acute because hospitals cannot easily “scale up” a specific ready-to-use container product. During shortages:

  • utilization shifts to alternatives (other ready-to-use products or compounded regimens),
  • then reverts when supply normalizes,
  • creating lumpy quarter-to-quarter sales rather than linear demand.

What is the competitive landscape for TRAVASOL-style ready-to-use PN admixtures in plastic containers?

Short answer: Competition is primarily other PN ready-to-use admixtures and component-based compounding using amino acid, dextrose, electrolyte kits.

The competitive set typically includes:

  • Ready-to-use PN mixtures across similar dextrose and amino acid concentration ranges
  • Alternative branded PN admixtures offered by major sterile injectables players
  • Hospital compounding from PN components (often using standardized recipes and automated compounding systems)

Where does TRAVASOL typically win?

  • Supply reliability and container format usability
  • Stability and compatibility profile in hospital workflows
  • Formulary positioning in pharmacy protocols

Where does TRAVASOL typically face substitution?

  • When hospitals can replace with a lower-cost PN product in the same “therapy class”
  • During specific shortages where allocated supply pushes substitution
  • When clinical dosing targets can be met using alternative concentration strengths

When does TRAVASOL 4.25% sulfite free lose exclusivity or face generic entry risk?

Short answer: Exclusivity and generic entry timing cannot be determined from the provided prompt alone.

To compute exclusivity or generic launch risk, the patent estate and regulatory exclusivity package for this specific formulation, container type, and concentration would be required. Without Orange Book/NDA reference, patent numbers, and legal status for the specific product configuration, a correct exclusivity timeline cannot be produced.


What is the Orange Book status of TRAVASOL 4.25% sulfite free in dextrose 25%?

Short answer: Not determinable from the provided information.

Orange Book status depends on:

  • The listed application (NDA/ANDA) for this exact product configuration
  • Patents and exclusivities listed for that NDA
  • Whether the product is protected by formulation, method-of-use, packaging, or process patents

No such dataset is included in the prompt.


What patent types typically protect ready-to-use PN admixtures like TRAVASOL?

Short answer: Formulation composition, manufacturing process, and packaging-related stability are the common protection areas.

For PN products, protection often targets:

  • Amino acid and electrolyte composition and concentration-specific combinations
  • Stabilizers and sulfite-free composition approaches
  • Manufacturing and sterilization processes
  • Compatibility/stability in plastic containers under defined storage conditions

This is a structural description of typical IP patterns in sterile injectables, not a product-specific patent mapping for TRAVASOL.


How do settlements, FDA actions, or litigation affect PN product availability and sales?

Short answer: For hospital PN products, availability shocks tend to drive short-run revenue volatility.

Financial trajectory for sterile injectables is frequently shaped by:

  • regulatory enforcement actions tied to manufacturing compliance,
  • FDA safety communications impacting distribution or labeling,
  • and supply disruptions that lead to temporary substitution.

A product-specific litigation or enforcement timeline for TRAVASOL 4.25% sulfite free dextrose 25% is not available in the provided context, so event-driven financial impacts cannot be quantified.


What is the regulatory pathway for TRAVASOL PN admixtures, and how does it affect competition?

Short answer: Competition typically depends on whether an equivalent NDA is approved, whether compounding is allowed, and whether exclusivities/patents constrain ANDA entry.

PN ready-to-use injectables are typically governed by:

  • NDA approvals for the formulation and manufacturing controls,
  • potential ANDA pathways for equivalents where permitted,
  • and pharmacy compounding rules outside the approved product market.

The regulatory status for this exact TRAVASOL configuration is not provided, so pathway-level analysis cannot be completed.


How does TRAVASOL perform financially versus alternative PN options?

Short answer: Product economics usually track institutional procurement decisions and service-line standardization.

Because PN is a pharmacy-administered therapy with standardized dosing workflows, financial performance versus alternatives is typically determined by:

  • unit price under contract,
  • effective net price after rebates and GPO pricing,
  • relative availability during demand peaks,
  • and formulary stickiness.

However, without net sales, ASP, unit shipments, and contract margin data for this exact product configuration, a quantitative comparison cannot be constructed.


Revenue exposure: what portion of TRAVASOL’s market is concentrated in U.S. hospital channels?

Short answer: The revenue is overwhelmingly hospital-led, but the share-by-channel is not provided.

PN products in this class generally monetize through:

  • hospital inpatient distribution,
  • contract pharmacy buying groups,
  • and IDN procurement.

No dataset in the prompt indicates whether TRAVASOL’s shipments are primarily U.S. hospital or diversified to broader channels (alternate care settings, wholesalers outside the hospital channel, or international markets).


Key business risks for TRAVASOL’s financial trajectory

Short answer: Contract pricing pressure and substitution during supply or formulary changes are the dominant risks.

Primary risks:

  1. Formulary displacement risk if competitors underbid or secure preferred placement in PN order sets.
  2. Supply disruption risk that forces substitution and can take time to reverse post-shortage.
  3. Ingredient-cost inflation risk affecting amino acids, dextrose, electrolytes, and packaging inputs.
  4. Compliance and sterility assurance risk in sterile injectables manufacturing.
  5. Regulatory labeling changes impacting packaging or administration guidance.

These risks are characteristic for sterile injectables broadly; product-specific risk events are not included in the prompt.


Key commercial opportunities

Short answer: Stickiness through hospital PN standardization and competition-neutral differentiation.

Opportunities typically come from:

  • expanding inclusion in PN protocols for ICUs and surgical units,
  • leveraging supply performance and lead times,
  • and addressing procurement preferences for plastic containers and sulfite-free specifications where clinically required.

Again, product-specific uptake evidence is not provided.


Timeline model for a PN product’s sales pattern (what to expect quarter to quarter)

Short answer: Expect lumpy demand driven by inpatient census and intermittent supply constraints.

A realistic sales pattern for PN products typically reflects:

  • seasonal fluctuations in hospitalization acuity,
  • year-to-year variation in surgical case volume,
  • procurement tender cycles at IDNs,
  • temporary shocks from manufacturing or allocation.

A quantitative timeline requires product shipment or revenue time series, which is not provided.


Key Takeaways

  • TRAVASOL’s market dynamics are primarily hospital procurement and PN protocol standardization, not broader outpatient market growth.
  • Pricing power is constrained by substitutability and contracting cycles.
  • Financial trajectory is likely volatile around supply and formulary changes, with demand rooted in inpatient acuity.
  • A decision-grade view of exclusivity, Orange Book status, and patent or litigation-driven generic risk cannot be produced from the information given.

FAQs

  1. How do ready-to-use PN admixtures typically win hospital formulary adoption?
  2. What causes quarter-to-quarter sales volatility for sterile injectables like PN solutions?
  3. How does plastic container selection affect substitution versus compounding in hospitals?
  4. What are the most common reasons hospitals switch between PN ready-to-use competitors?
  5. How do supply allocations during shortages change long-term share in PN mixtures?

References

  1. No sources were provided in the prompt.

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