When will the patents on DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER expire, and when will generic DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% 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
B Braun	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018268-001	Approved Prior to Jan 1, 1982		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 4, 2026

Dextrose 5%, sodium chloride 0.45% and potassium chloride 0.15% injection is a mature, multisource intravenous fluid used for fluid replacement, maintenance therapy, carbohydrate supplementation and potassium replacement. Its commercial profile is defined by low unit pricing, hospital-contract procurement, manufacturing concentration, freight costs, and recurring shortages rather than patent exclusivity.

Standalone revenue for this exact formulation is not publicly reported. Financial performance is generally captured within broader intravenous solutions, parenteral nutrition, hospital products or medical-products segments reported by manufacturers such as Baxter, B. Braun, Fresenius Kabi and ICU Medical.

What is dextrose 5%, sodium chloride 0.45% and potassium chloride 0.15% injection?

The product is a sterile intravenous solution commonly supplied in flexible plastic containers. A nominal one-liter container contains the following:

Component	Concentration	Approximate content per liter	Clinical role
Dextrose	5%	50 g	Carbohydrate and water
Sodium chloride	0.45%	4.5 g	Sodium and chloride replacement
Potassium chloride	0.15%	1.5 g	Potassium replacement
Sodium	Approximately 77 mEq/L	77 mEq	Electrolyte replacement
Chloride	Approximately 77 mEq/L	77 mEq	Electrolyte replacement
Potassium	Approximately 20 mEq/L	20 mEq	Potassium replacement
Dextrose energy	Approximately 170 kcal/L	170 kcal	Limited caloric support

The solution is typically hyperosmolar relative to plasma because it combines dextrose with sodium chloride and potassium chloride. Product labeling controls the approved indications, administration rate, contraindications, storage conditions and warnings concerning hyperglycemia, fluid overload, electrolyte imbalance and potassium administration.[1]

How large is the market for this IV fluid?

The addressable market is a narrow subsegment of the much larger U.S. large-volume parenteral market. Demand comes mainly from hospitals, ambulatory surgery centers, emergency departments, long-term-care facilities and specialty pharmacies that purchase institutional injectable products.

The commercial market has five defining characteristics:

Demand is recurring and clinically necessary.
Volume is high relative to unit price.
Purchasing is concentrated through group purchasing organizations and hospital systems.
Products are difficult to substitute during supply interruptions because alternatives may have different electrolyte concentrations or dextrose content.
Manufacturing economics depend heavily on plant utilization, resin, packaging, sterilization and distribution costs.

Exact market value is not separately disclosed by public companies or FDA databases. Reported manufacturer revenue normally combines multiple IV solutions, premixed drugs, irrigation products and other hospital injectables.

Primary demand drivers

Demand is linked to hospital admissions, surgical procedures, emergency care, dehydration treatment, electrolyte management and institutional protocols. The formulation has a narrower use profile than plain 5% dextrose injection or 0.9% sodium chloride injection because it includes potassium and hypotonic sodium chloride.

Demand therefore depends on:

Hospital bed utilization.
Surgical and emergency department volume.
Availability of competing electrolyte solutions.
Clinical substitution policies.
Hospital inventory levels.
Seasonal changes in inpatient activity.
Shortages affecting normal saline, dextrose solutions or potassium-containing products.

The product is not a high-growth pharmaceutical. Unit demand is relatively stable, while revenue growth primarily comes from price changes, contract wins, supply disruptions and changes in product mix.

Which companies manufacture or compete with this formulation?

Competition varies by country and by container size. Major global suppliers of large-volume parenteral products include Baxter, B. Braun, Fresenius Kabi and ICU Medical. Regional manufacturers and contract suppliers may also market equivalent formulations under separate National Drug Codes.

Company	Relevant competitive position
Baxter	Large U.S. hospital-products supplier with extensive IV solution manufacturing and distribution
B. Braun	Global supplier of IV fluids, infusion systems and hospital products
Fresenius Kabi	Large supplier of generic injectables, IV solutions and clinical nutrition products
ICU Medical	Hospital infusion and injectable-products supplier, including products obtained through acquisitions and portfolio expansion
Regional manufacturers	Compete through lower prices, tenders, local supply and contract manufacturing

The exact supplier set depends on whether the analysis covers the United States, Europe, Canada, Latin America or emerging markets. Formulation equivalence does not guarantee commercial interchangeability because hospitals also evaluate container design, port configuration, labeling, overwrap, storage conditions, availability and compatibility with infusion equipment.

What is the FDA regulatory status of this formulation?

The product is generally regulated as a prescription injectable drug under the Federal Food, Drug, and Cosmetic Act. U.S. products may be approved through abbreviated new drug applications or older approval pathways, depending on the manufacturer and product history.

FDA regulatory considerations include:

Sterility assurance.
Endotoxin control.
Container-closure integrity.
Particulate limits.
Label accuracy.
Stability and expiration dating.
Manufacturing process validation.
Compatibility of the plastic container with the solution.
Control of potassium concentration and final osmolarity.

The FDA’s Orange Book is principally relevant to approved drug applications and therapeutic-equivalence determinations. For a mature multisource IV solution, market access normally depends on ANDA approval, manufacturing compliance and commercial supply rather than a proprietary new-drug approval.

What is the Orange Book and patent status?

No meaningful product-specific patent barrier is generally associated with this mature electrolyte formulation. Dextrose, sodium chloride and potassium chloride are long-established active ingredients, and the basic solution composition is not commercially protected by a modern exclusivity estate.

Exclusivity category	Expected relevance
New chemical entity exclusivity	None
Orphan-drug exclusivity	None
Pediatric exclusivity	Not a routine feature of this product
New formulation exclusivity	Generally absent for the basic formulation
Drug-device exclusivity	May be relevant only to a proprietary delivery system, not the solution itself
Orange Book patents	Typically no blocking patent estate for the basic formulation
Biosimilar exclusivity	Not applicable

Patent risk may arise from a proprietary container, administration device, manufacturing process or packaging system. Those rights would not normally prevent another manufacturer from producing the same active solution in a different compliant container.

When does this formulation lose exclusivity?

The formulation has effectively operated in a post-exclusivity market for decades. There is no single future loss-of-exclusivity date comparable to the expiration of a branded small-molecule patent.

Commercial exclusivity is instead determined by:

FDA approval status.
Manufacturing capacity.
Hospital contracts.
Product availability.
Regulatory compliance.
Supply-chain reliability.
Shortage conditions.

The absence of patent protection does not guarantee immediate generic entry. Sterile injectable manufacturing requires validated facilities, specialized equipment, quality systems and reliable access to packaging components. These operational barriers can limit the number of active suppliers even when legal barriers are minimal.

Are Paragraph IV challenges relevant?

Paragraph IV litigation is generally not a central risk for this product. A Paragraph IV certification challenges a listed patent in connection with an ANDA. A mature, nonproprietary IV solution typically has no commercially significant Orange Book patent blocking the basic formulation.

Potential ANDA disputes would more likely involve:

A specific proprietary container.
A drug-device combination.
A preservative or formulation variation.
A method of manufacture.
A labeling issue.
A patent listed for a particular branded presentation.

For the core formulation, competitive risk is more likely to arise from production expansion, contract repricing or shortage-driven supply changes than from Paragraph IV litigation.

What formulation patents protect the product?

The core formulation is unlikely to be protected by enforceable composition patents because its components and concentrations are established pharmaceutical ingredients. Potential intellectual-property protection can instead relate to the presentation:

Container and delivery-system rights

Possible protected features include:

Multilayer plastic construction.
Moisture or oxygen barriers.
Port design.
Additive compatibility.
Collapsible-container geometry.
Overwrap systems.
Tamper-evident packaging.
Infusion-device connections.

These rights can create differentiation, but they do not necessarily block a competing manufacturer using another compliant container.

Manufacturing and sterilization rights

Manufacturing barriers can include:

Terminal sterilization processes.
Aseptic filling methods.
Automated inspection systems.
High-throughput formulation and filling equipment.
Container-closure integrity testing.
Reduced-extractable packaging materials.

Trade secrets and process know-how may have greater practical value than patents in this market. The main risk is often the ability to produce sterile product consistently at scale.

What patent litigation or settlement agreements affect this product?

There is no major branded-product litigation pattern associated with the basic formulation. Settlement agreements involving this category would have limited commercial significance unless they affected a leading supplier’s container technology or a broader injectable portfolio.

The relevant legal exposures are more likely to involve:

Product-liability claims.
Manufacturing deviations.
FDA warning letters.
Recalls.
Contract disputes.
Antitrust allegations involving supply or contracting.
Intellectual-property disputes over packaging or delivery systems.

These matters can affect product availability and financial performance without changing the underlying patent position.

How do shortages affect the market?

Shortages are the primary source of pricing power and earnings volatility. FDA and ASHP shortage records have repeatedly identified injectable fluids, including saline, dextrose and electrolyte-containing products, as vulnerable to supply disruption.[2,3]

Shortage risk is concentrated in a small number of manufacturing and packaging facilities. Disruptions can result from:

Hurricane or storm damage.
Sterility failures.
Quality investigations.
Equipment breakdowns.
Raw-material shortages.
Plastic-resin constraints.
Port or freight disruptions.
Production prioritization during public-health emergencies.

When a competing fluid is unavailable, hospitals may purchase substitute concentrations or alternative container sizes. Substitution can increase revenue for available suppliers, but it can also raise regulatory, clinical and inventory-management costs.

Shortage-driven price increases are usually temporary. Once capacity returns, hospital buyers tend to push prices toward contract and generic levels.

What is the financial trajectory for this product?

The expected long-term trajectory is stable volume, low organic growth and episodic pricing volatility.

Period	Expected market condition	Financial effect
Near term	Stable institutional demand with periodic supply interruptions	Revenue can rise through price increases and shortage allocation
Medium term	Capacity normalization and contract repricing	Margin pressure and lower shortage premiums
Long term	Mature demand tied to hospital utilization	Low single-digit nominal growth at most, absent supply disruption

Revenue depends more on portfolio scale than on this individual formulation. A manufacturer with a broad IV-solutions portfolio can use production capacity, distribution density and hospital contracts to improve economics. A small supplier may face unfavorable costs because sterile filling, testing and freight expenses consume a larger share of sales.

Key financial variables

The most important drivers are:

Average selling price per container.
Annual unit volume.
Container size and mix.
Hospital contract renewals.
Manufacturing utilization.
Cost of plastic resin and packaging.
Sterilization and quality-control expenses.
Freight and cold-chain requirements, where applicable.
Recall and remediation costs.
Shortage-related allocation decisions.

Because the product is inexpensive per unit, profitability depends on throughput. A plant operating below capacity can lose money even with a clinically necessary product. A plant operating near full capacity can generate attractive contribution margins if quality costs remain controlled.

How strong is the patent estate for this drug?

The patent estate is weak or effectively nonexistent for the basic formulation. The commercial moat is operational rather than legal.

Competitive barrier	Strength
Composition patent	Very weak
Regulatory exclusivity	Very weak
Orange Book blocking patent	Generally weak
Sterile manufacturing capability	Strong
Hospital contracting	Moderate to strong
Distribution scale	Strong
Supply reliability	Strong
Container differentiation	Moderate
Clinical brand loyalty	Weak

A supplier with reliable inventory can outperform a nominally equivalent competitor. Hospitals may accept a higher price for continuity of supply, validated packaging and fewer back orders.

What generic launch scenarios exist?

A new supplier would face low legal entry barriers but significant operational barriers.

Base-case launch

The entrant obtains FDA approval, qualifies manufacturing and secures limited hospital contracts. Pricing remains competitive, with modest market share because established suppliers have stronger distribution.

Shortage-driven launch

A shortage creates an opportunity for rapid uptake. Hospitals may approve the product through emergency purchasing or temporary formulary substitution. Market share can increase quickly, but it may decline after incumbent supply returns.

Contract-driven launch

A group purchasing organization or major health system awards a contract to the entrant. The entrant gains volume but accepts lower prices and strict service-level requirements.

Capacity-constrained launch

The product receives approval but cannot scale because of filling capacity, plastic-container availability or quality-system limitations. Regulatory approval alone does not produce meaningful revenue.

What geographic markets are most attractive?

The United States offers high demand and established reimbursement channels but has strict manufacturing and shortage-reporting requirements. Europe is more fragmented because procurement is often country-specific and tender-driven. Emerging markets may offer higher unit growth but lower prices, greater currency risk and more variable regulatory enforcement.

Region	Commercial profile
United States	Large institutional market, strong GPO influence, shortage sensitivity
Europe	Tender pricing, country-by-country access, mature hospital demand
Japan	Regulated market with established local suppliers
China	Large hospital demand and local manufacturing competition
Latin America	Growth potential with pricing and currency pressure
Middle East and Africa	Tender-based demand with import and supply-chain risk

Geographic expansion is more likely to improve volume than margin. Local manufacturing or regional packaging may be required to compete effectively in price-sensitive tenders.

Is biosimilar competition relevant?

No. Biosimilars apply to biological products. This formulation contains small-molecule and inorganic active ingredients in an aqueous solution. Competition comes from generic injectable manufacturers and therapeutic substitutes, not biosimilar developers.

Key Takeaways

Dextrose 5%, sodium chloride 0.45% and potassium chloride 0.15% injection is a mature, multisource IV fluid.
The formulation has no meaningful composition-based patent moat.
Orange Book patents, Paragraph IV litigation and biosimilar competition are generally not central commercial risks.
Revenue is not publicly disclosed at the individual-product level.
Financial performance depends on hospital utilization, contract pricing, production scale and supply continuity.
Shortages can create temporary pricing power and market-share shifts.
Manufacturing, sterility assurance, plastic-container supply and distribution are stronger barriers than patents.
The long-term outlook is stable volume with low structural growth and periodic volatility from supply disruptions.
The most attractive commercial position belongs to suppliers with reliable sterile capacity, broad hospital contracts and multiple IV-fluid presentations.

FAQs

What is the potassium concentration in this IV solution?

The formulation contains approximately 20 mEq of potassium per liter because 0.15% potassium chloride equals approximately 1.5 grams per liter.

Is this product a generic drug?

It is generally marketed as a multisource injectable product, often through an abbreviated approval pathway or legacy approval framework. The precise regulatory pathway depends on the manufacturer and National Drug Code.

Can hospitals substitute normal saline for this formulation?

Not automatically. Normal saline lacks dextrose and potassium and has a different sodium chloride concentration. Substitution requires clinical review and may alter electrolyte and glucose delivery.

Does the plastic container create patent protection?

A particular plastic container or port system may be protected, but container rights usually do not create exclusivity over the underlying dextrose, sodium chloride and potassium chloride formulation.

What is the main investment risk for manufacturers?

The largest risks are sterile-manufacturing failures, facility outages, quality remediation, low plant utilization, hospital contract repricing and unexpected declines in shortage-related pricing.

References

U.S. Food and Drug Administration. (n.d.). Dextrose, sodium chloride, and potassium chloride injection prescribing information. FDA labeling database.
U.S. Food and Drug Administration. (n.d.). Drug shortages database. https://www.accessdata.fda.gov/scripts/drugshortages/
American Society of Health-System Pharmacists. (n.d.). ASHP drug shortages resource center. https://www.ashp.org/drug-shortages
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.
Baxter International Inc. (2024). Annual report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.
B. Braun Melsungen AG. (2024). Annual report 2023. B. Braun Melsungen AG.
Fresenius Kabi AG. (2024). Annual report 2023. Fresenius Kabi AG.

US Patents:	0
Applicants:	1
NDAs:	1
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DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER Drug Patent Profile

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Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

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Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 0.15% Injection Market Dynamics and Financial Trajectory