When will the TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER patents expire, and when will generic TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER be available?

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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

Last updated: August 13, 2026

TRAVASOL 4.25% sulfite-free with electrolytes in dextrose 5% is a mature parenteral-nutrition product marketed by Baxter Healthcare. Its commercial value is driven by hospital and home-infusion demand for peripheral or supplemental parenteral nutrition, not by patent exclusivity. The product has limited standalone financial disclosure, no meaningful biosimilar exposure, and low conventional generic-entry risk because amino-acid/dextrose injections are sterile manufacturing products with complex formulation, container, and supply requirements.

The financial trajectory is likely stable to low-growth in nominal terms, with margin performance more sensitive to contract pricing, manufacturing utilization, raw-material costs, and shortages than to prescription-volume expansion.

What is TRAVASOL 4.25% in dextrose 5%?

TRAVASOL is an intravenous amino-acid formulation containing 4.25% amino acids with electrolytes in 5% dextrose. The product is administered as part of parenteral nutrition when oral or enteral feeding is inadequate, contraindicated, or not tolerated. Its use is generally concentrated in hospitals, intensive-care units, surgical services, neonatal and pediatric care, and home-infusion programs.[1]

The formulation provides:

Product characteristic	Commercial relevance
Amino acids	Supplies nitrogen and protein substrate
Dextrose 5%	Provides carbohydrate calories and solution volume
Electrolytes	Reduces the need for some separate electrolyte additions
Sulfite-free formulation	Avoids sulfite exposure in susceptible patients
Plastic container	Supports storage, transport, and institutional administration
Intravenous route	Requires sterile manufacturing and controlled distribution
Prescription hospital product	Sales are primarily institutional rather than retail

TRAVASOL is not a biologic, vaccine, small-molecule tablet, or high-value specialty drug. It is a sterile injectable nutrition product whose value depends on reliable supply and hospital formulary inclusion.

What is the FDA status of TRAVASOL?

TRAVASOL is an FDA-regulated prescription injectable product with labeling describing amino-acid injection with electrolytes in dextrose. The DailyMed label identifies Baxter Healthcare Corporation as the manufacturer or labeler for the product presentation.[1]

The product is used in parenteral nutrition and carries the clinical restrictions associated with intravenous nutrition, including risks from metabolic abnormalities, fluid overload, hyperglycemia, electrolyte imbalance, and catheter-related complications.[1]

The FDA regulatory profile is commercially important because:

Sterile injectable products require validated aseptic processing.
Manufacturing changes can require regulatory review.
Hospital purchasers place high value on continuity of supply.
Substitution depends on concentration, electrolyte composition, container, administration compatibility, and institutional protocol.
A product can lose share through supply disruption even when demand remains stable.

TRAVASOL competes in a regulated hospital-injection market rather than in a conventional retail-generic market.

What patents protect TRAVASOL?

No material active patent barrier is associated with the core TRAVASOL 4.25% amino-acid and dextrose formulation in the public product information reviewed. The product is based on a long-established parenteral-nutrition composition, and its commercial protection does not depend on a novel active pharmaceutical ingredient.

IP category	TRAVASOL position
Active-ingredient patent	None expected for the established amino-acid mixture
Composition-of-matter patent	Not commercially relevant
Formulation patent	No material current barrier identified
Method-of-use patent	No meaningful exclusivity identified
Device or container patent	Possible at platform level, but not a clear product-specific barrier
Orange Book patent protection	No meaningful product-specific patent barrier identified
Regulatory exclusivity	No current exclusivity-based market protection identified
Biosimilar protection	Not applicable

Patent expiration is therefore not the principal driver of TRAVASOL’s competitive position. Any patent disputes involving parenteral-nutrition manufacturing, multilayer containers, compounding systems, or related products would be unlikely to create a direct barrier to substitution for the mature formulation.

When does TRAVASOL lose exclusivity?

TRAVASOL’s economically relevant exclusivity has already expired or is not based on a current patent term. The product competes through regulatory approval, manufacturing capability, supply reliability, pricing, contracting, and hospital purchasing relationships.

A Paragraph IV challenge is unlikely to be strategically important for this product because Paragraph IV litigation typically targets an Orange Book-listed patent associated with an innovator drug. A mature amino-acid/dextrose injectable product with no meaningful listed patent barrier is more likely to face ordinary abbreviated-application competition, contract switching, or therapeutic substitution than patent litigation.

How many competitors cover the parenteral-nutrition market?

Competition is fragmented across premixed amino-acid/dextrose products, amino-acid-only products, multi-chamber bags, compounded nutrition, and customized total parenteral nutrition.

Key competitive categories include:

Competitive category	Examples or relevant suppliers	Substitution risk
Premixed amino acids and dextrose	Baxter Clinimix and related products	High
Amino-acid injections	Baxter Travasol and competing formulations	Moderate to high
Multi-chamber parenteral-nutrition bags	Baxter and other hospital suppliers	Moderate
Customized compounded TPN	Hospital pharmacies and outsourcing facilities	Moderate
Specialty neonatal nutrition	Specialized institutional formulations	Lower direct substitution
Imported or regional sterile injectables	Contract manufacturers and generic suppliers	Variable

Clinimix is especially relevant because it is a premixed amino-acid and dextrose product used in the same broader parenteral-nutrition workflow. The exact substitution relationship depends on amino-acid concentration, electrolyte content, caloric requirements, osmolarity, patient population, and hospital protocol.

How strong is the TRAVASOL patent estate?

The patent estate is weak as a source of exclusivity but the manufacturing position can still be defensible.

Manufacturing and IP barriers

The most relevant barriers are operational:

validated sterile filling and terminal or aseptic processing;
control of particulate, endotoxin, sterility, and container integrity;
formulation stability over the labeled shelf life;
compatibility of the plastic container with the solution;
quality systems for high-volume injectable production;
regulatory comparability after facility or process changes;
reliable access to amino acids, dextrose, electrolytes, containers, and closures;
hospital qualification and supplier approval.

These barriers raise the cost of entry but do not create durable monopoly pricing. A qualified competitor can eventually enter if it can demonstrate equivalent quality, secure manufacturing capacity, and win hospital contracts.

What is the Orange Book status of TRAVASOL?

The product does not appear to have a commercially significant Orange Book patent position. The Orange Book is most relevant where an approved drug has listed patents that an ANDA applicant must address.[2]

For TRAVASOL, the principal commercial questions are likely to be:

Whether an equivalent injectable product has approval for the same concentration and presentation.
Whether the competitor can meet the same sterile manufacturing requirements.
Whether the hospital accepts the alternative container and electrolyte profile.
Whether the supplier has adequate allocation and shortage-management capacity.
Whether the product is covered under a group-purchasing or institutional contract.

The absence of patent exclusivity increases competitive exposure but does not guarantee immediate generic displacement. Injectable nutrition products often experience slower switching than oral generics because hospitals manage them through protocols, supply contracts, pharmacy operations, and safety reviews.

Which companies are challenging TRAVASOL?

The most credible challengers are companies with established sterile-injectable or parenteral-nutrition platforms rather than traditional retail-generic companies.

Competitive pressure can come from:

Baxter’s own alternative nutrition products;
Fresenius Kabi parenteral-nutrition products;
ICU Medical and related infusion-product suppliers;
regional sterile-injectable manufacturers;
hospital pharmacy compounding operations;
outsourcing facilities supplying compounded nutrition;
suppliers of multi-chamber parenteral-nutrition bags.

The competitive set varies by country because product approvals, hospital procurement contracts, pharmacy-compounding rules, and shortage conditions differ across jurisdictions.

What is the market size and revenue exposure?

Baxter does not publicly report standalone revenue for TRAVASOL. The product is embedded within broader pharmaceutical, injectable, and clinical-nutrition reporting. As a result, product-level sales, gross margin, market share, and contribution profit cannot be reliably isolated from Baxter’s public financial statements.[3]

The product’s revenue exposure is likely shaped by five factors:

Driver	Effect on TRAVASOL
Hospital admissions	Supports baseline demand
ICU and surgical utilization	Increases use of parenteral nutrition
Enteral-feeding preference	Limits long-term volume growth
Supply shortages	Can create temporary volume spikes or losses
Contract pricing	Places pressure on net price and margin

Parenteral nutrition is clinically important but represents a relatively small portion of total hospital drug spending. TRAVASOL is therefore unlikely to be a major companywide revenue driver. Its financial value is more consistent with a mature portfolio product that contributes recurring volume, manufacturing utilization, and customer retention.

What is the financial trajectory for TRAVASOL?

The most probable trajectory is mature and defensive:

Base case

Volume remains broadly stable as hospitals continue to require injectable nutrition for patients unable to receive adequate enteral feeding. Net pricing is constrained by group-purchasing organizations, hospital tenders, and competing premixed formulations. Revenue grows slowly, if at all, in real terms.

Upside case

Revenue can improve during competitor shortages, manufacturing exits, or disruptions affecting alternative amino-acid and dextrose products. A supplier with available capacity can capture temporary market share and secure new institutional contracts.

Downside case

Revenue and margin can decline if:

hospitals shift toward enteral nutrition;
a competitor offers lower contract pricing;
Baxter experiences a manufacturing or supply interruption;
hospitals adopt alternative premixed bags;
procurement organizations consolidate suppliers;
input and quality costs rise faster than prices.

The main financial risk is not patent loss. It is commoditization combined with sterile-injectable supply risk.

What generic entry risks exist for TRAVASOL?

Generic entry risk is moderate at the product level and high at the market level.

A competing product may be able to enter without confronting meaningful patent litigation. However, the entrant must still overcome:

FDA approval requirements for an injectable formulation;
sterile manufacturing validation;
container and closure compatibility;
stability and extractables/leachables testing;
facility inspection and quality compliance;
hospital conversion costs;
supply reliability expectations;
reimbursement and contracting requirements.

The likely launch pattern is gradual rather than an immediate broad substitution event. New entrants may begin with selected hospitals or regional contracts, then expand if they demonstrate reliable supply and acceptable pricing.

What patent litigation or settlement agreements affect TRAVASOL?

No material product-specific patent litigation or Paragraph IV settlement is identified as a central commercial issue for TRAVASOL. The product’s competitive environment is more likely to be affected by:

FDA manufacturing inspections;
drug-shortage notifications;
product recalls;
contract awards;
facility expansions;
supply-allocation decisions;
hospital formulary changes.

FDA drug-shortage data are particularly relevant because sterile injectables and parenteral-nutrition products can experience supply constraints tied to facility capacity, raw materials, quality events, or manufacturing interruptions.[4]

How does TRAVASOL compare with Clinimix?

Attribute	TRAVASOL 4.25% in Dextrose 5%	Clinimix and similar premixed products
Product type	Amino acids with electrolytes in dextrose	Premixed amino acids and dextrose
Primary use	Parenteral nutrition support	Parenteral nutrition support
Patent value	Low	Low to moderate at platform level
Substitution	Depends on formulation and protocol	Depends on formulation and protocol
Main advantage	Established product and familiar presentation	Premixed workflow and operational convenience
Main risk	Commodity pricing and supply interruption	Price competition and supply interruption
Biosimilar exposure	None	None
Main commercial channel	Hospitals and home infusion	Hospitals and home infusion

TRAVASOL can retain demand where its concentration, electrolyte composition, container, or procurement status fits institutional protocols. Clinimix and other premixed products can gain share where hospitals prioritize simplified preparation and standardized nutrition workflows.

What is the geographic coverage of TRAVASOL?

TRAVASOL’s commercial relevance is strongest in the United States, where Baxter has established hospital and infusion-distribution channels. International availability depends on local registrations, product names, presentation differences, and country-specific parenteral-nutrition requirements.

Geographic risks include:

local sterile-manufacturing capacity;
import and export restrictions;
national tender pricing;
reimbursement controls;
country-specific nutrition protocols;
availability of alternative amino-acid formulations.

The U.S. market remains the most important reference point for Orange Book, FDA, shortage, and ANDA analysis.

Key Takeaways

TRAVASOL 4.25% sulfite-free with electrolytes in dextrose 5% is a mature Baxter parenteral-nutrition injectable.
Its market is driven by hospitals, intensive-care units, surgery, pediatrics, and home infusion.
No material active patent or regulatory-exclusivity barrier is the principal source of commercial protection.
Paragraph IV litigation and biosimilar competition are not central risks.
Generic and alternative-product competition is possible, but sterile manufacturing and hospital qualification slow substitution.
Product-level revenue is not separately disclosed by Baxter.
The likely financial trajectory is stable to low-growth, with margin pressure from institutional contracting and commodity competition.
Shortages, manufacturing reliability, and procurement contracts are more important than patent expiration.
Clinimix, competing amino-acid/dextrose products, customized TPN, and compounded nutrition are the main competitive alternatives.
The principal investment risk is operational and pricing-related rather than IP-related.

FAQs

Is TRAVASOL a generic drug?

TRAVASOL is a branded sterile injectable nutrition product. Its active nutritional components are established ingredients, and its commercial position does not depend on new-molecule exclusivity.

Can a hospital substitute Clinimix for TRAVASOL?

Substitution depends on the amino-acid concentration, electrolyte composition, dextrose content, osmolarity, administration requirements, institutional protocol, and pharmacy approval. The products are competitors but are not automatically interchangeable in every patient or hospital setting.

Does TRAVASOL have biosimilar competition?

No. Biosimilar regulation applies to biologic products. TRAVASOL is an amino-acid and dextrose injectable solution.

What would most likely increase TRAVASOL sales?

Competitor shortages, hospital contract wins, increased use of parenteral nutrition, and reliable supply during industry disruptions would be the strongest near-term volume drivers.

Is TRAVASOL likely to face a patent-based generic launch?

A patent-based launch challenge appears unlikely because the product does not have a material current patent barrier identified in the public record. Competition is more likely to arise through sterile injectable approvals, hospital tenders, and supply-based substitution.

References

DailyMed. (n.d.). Travasol 4.25% sulfite free with electrolytes in dextrose 5% prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
Baxter International Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. https://investor.baxter.com/
U.S. Food and Drug Administration. (2024). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
Worthington, P., Balint, J., Bechtold, M., et al. (2017). When is parenteral nutrition appropriate? Journal of Parenteral and Enteral Nutrition, 41(3), 324-377. https://doi.org/10.1177/0148607117695250

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

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