DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Dextrose 10% And Sodium Chloride 0.2% In Plastic Container, and what generic alternatives are available?

Dextrose 10% And Sodium Chloride 0.2% In Plastic Container is a drug marketed by B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER is dextrose; sodium chloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

Summary for DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER at DailyMed

Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.2% 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
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018386-001	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-012	Feb 24, 1988		RX	No	No

Dextrose 10% and Sodium Chloride 0.2% in Plastic Containers: Market Dynamics, Supply Risk and Financial Outlook

Last updated: September 9, 2026

Dextrose 10% and sodium chloride 0.2% injection is a mature, nonproprietary intravenous fluid used primarily in hospital and neonatal settings. Its commercial value comes from recurring institutional demand, not patent protection or brand differentiation. Pricing is typically low, competition is intense, and profitability depends on manufacturing scale, container availability, hospital contracts, and supply reliability.

The product has no meaningful branded-drug exclusivity profile. It is generally marketed as an abbreviated new drug application, or ANDA, product and is listed in FDA labeling databases by multiple manufacturers or contract suppliers. Product-level revenue is rarely disclosed because companies usually report it within broader sterile injectables, IV solutions, or hospital products segments.

What is dextrose 10% and sodium chloride 0.2% injection?

Dextrose 10% and sodium chloride 0.2% injection is a sterile intravenous solution containing:

Component	Concentration
Dextrose	10 g per 100 mL
Sodium chloride	0.2 g per 100 mL
Dextrose per 1-liter container	100 g
Sodium chloride per 1-liter container	2 g

A 1-liter container provides approximately 340 kilocalories from dextrose. The solution is hypertonic relative to plasma and is used under medical supervision for fluid, carbohydrate, and electrolyte administration. Clinical use depends on patient age, glucose needs, sodium requirements, renal function, and route of administration.

The principal users are hospitals, neonatal intensive-care units, pediatric units, emergency departments, infusion providers, and government healthcare systems. Demand is tied to procedure volume and inpatient utilization rather than consumer prescription behavior.

What is the FDA regulatory status of dextrose 10% and sodium chloride 0.2%?

The product is a conventional sterile injectable. FDA-approved versions are generally regulated through ANDAs or other abbreviated pathways rather than through new-drug development programs.

FDA product characteristics

Regulatory attribute	Assessment
Dosage form	Intravenous injection or infusion
Active ingredients	Dextrose and sodium chloride
Product category	Large-volume parenteral or small-volume sterile injectable, depending on container size and labeling
Prescription status	Institutional prescription product
FDA pathway	Primarily abbreviated or legacy sterile-product approvals
Biosimilar relevance	None
Controlled-substance status	None
Pediatric use	Common in neonatal and pediatric care, subject to clinical judgment
Orange Book relevance	Limited compared with branded pharmaceuticals
Patent-based exclusivity	Generally absent or commercially immaterial

FDA labeling is available through DailyMed and FDA drug databases. The exact regulatory status depends on the manufacturer, application number, container size, strength, and packaging configuration [1][2].

What patents protect dextrose 10% and sodium chloride 0.2%?

No commercially important composition patent is expected to protect the basic dextrose 10% and sodium chloride 0.2% formulation. Both active ingredients are longstanding, well-established substances. The product’s commercial barriers are operational and regulatory rather than patent-based.

Patent and exclusivity profile

Protection category	Commercial assessment
Active-ingredient patent	Expired or not relevant
Composition patent	No material protection expected
Method-of-use patent	No material protection expected for ordinary fluid and calorie replacement
Formulation patent	Limited; basic aqueous formulation is established
Container patent	Possible at the platform level, but not product-specific exclusivity
Manufacturing process patent	Possible for equipment or packaging systems, but unlikely to block competition
New chemical entity exclusivity	None
Orphan exclusivity	None
Pediatric exclusivity	Not expected to create a material barrier
Generic entry	Already established

The absence of patent protection means a new entrant does not need to overcome a branded product’s patent estate. It must satisfy FDA requirements for sterility, stability, container closure integrity, extractables and leachables, manufacturing controls, labeling, and bioequivalence or pharmaceutical equivalence requirements applicable to the product.

What formulations are protected by plastic-container technology?

The plastic container is commercially important even though it usually does not create product exclusivity. IV-solution suppliers use flexible containers made from materials such as polyolefin-based plastics. The container must maintain sterility, tolerate transport and storage, and minimize interaction with the solution.

Key manufacturing and packaging barriers

The main technical risks are:

• Sterilization-cycle validation.
• Container-closure integrity.
• Particulate control.
• Microbial contamination prevention.
• Compatibility with dextrose and sodium chloride solutions.
• Extractables and leachables.
• Label adhesion and readability.
• Port and tubing compatibility.
• Shipping durability.
• Stability through the labeled shelf life.

Dextrose solutions can support degradation reactions under certain conditions, particularly with heat exposure and extended storage. Manufacturers therefore manage sterilization conditions, oxygen exposure, light, container materials, and warehouse controls. These requirements raise the cost of entry but do not create the pricing power associated with patented specialty formulations.

How large is the market for dextrose and sodium chloride IV solutions?

The addressable market is part of the broader U.S. hospital injectable and IV-fluid market. Public company reporting normally combines this product with other dextrose injections, sodium chloride injections, balanced crystalloids, premixed solutions, and contract-manufactured sterile products.

The principal demand drivers are:

1. Hospital admissions and procedure volume.
2. Neonatal and pediatric inpatient activity.
3. Emergency department utilization.
4. Shortages of competing IV fluids.
5. Group purchasing organization contracts.
6. Government and public-hospital procurement.
7. Inventory policies for critical-care products.
8. Substitution between available dextrose and saline concentrations.

The product is usually a low-price, high-volume item. A hospital may pay more during constrained supply conditions, but ordinary purchasing is governed by competitive tenders, formularies, and multi-product contracts.

How does the product generate revenue?

Revenue is generated through institutional sales rather than retail prescriptions. Manufacturers sell directly or through distributors, group purchasing organizations, hospital systems, and government procurement channels.

A simplified revenue model is:

Revenue = unit volume x net price per container

Profit is more sensitive to conversion cost and plant utilization than to ingredient cost. Dextrose and sodium chloride are inexpensive relative to the total cost of producing, sterilizing, packaging, testing, storing, and distributing a sterile injectable.

Cost structure

Cost category	Relative importance
Dextrose and sodium chloride	Low
Water purification	Moderate
Plastic container and ports	Moderate to high
Sterilization	Moderate
Quality control and release testing	High
Labor and plant overhead	High
Freight and warehousing	Moderate
Regulatory compliance	Moderate
Product recalls and remediation	Potentially very high

The plastic container can materially affect margins. Resin prices, container-production capacity, port components, and supplier concentration can create cost pressure even when active-ingredient prices remain stable.

What is the financial trajectory for this product?

The long-term financial trajectory is mature and generally stable, with limited unit-price expansion. Nominal revenue can increase through higher hospital utilization, inflation-linked contract resets, supply shortages, or market share gains. Structural growth is usually modest.

Base-case financial outlook

Factor	Expected direction
Unit demand	Stable to modest growth
Net price	Low growth, with episodic increases during shortages
Gross margin	Stable if plant utilization remains high
Operating margin	Vulnerable to quality events and underutilized capacity
R&D spending	Minimal at the individual product level
Patent exposure	Minimal
Competitive intensity	High
Working-capital requirements	Meaningful because of inventory and contract supply
Revenue volatility	Usually low, except during shortages
Strategic value	Higher as part of a broad hospital-products portfolio

The most attractive commercial position is not ownership of this single formulation. It is ownership of a reliable sterile-injectables platform with multiple container sizes, strengths, and hospital contracts. A supplier can improve economics by manufacturing several products on the same equipment and using the same distribution network.

Which companies compete in dextrose and sodium chloride IV solutions?

Competition is fragmented across large sterile-injectable and hospital-product companies. Relevant supplier categories include:

• Baxter International.
• B. Braun Medical.
• Fresenius Kabi.
• ICU Medical.
• Pfizer and Hospira-related sterile injectable operations.
• Generic sterile-injectable manufacturers.
• Regional contract manufacturers.
• Government and hospital-system suppliers.

The exact competitive set varies by country, container size, NDC, FDA application, and purchasing contract. Product availability also changes when manufacturers discontinue presentations, experience manufacturing interruptions, or prioritize higher-demand saline and dextrose products.

A supplier with broad IV-fluid capacity has an advantage over a single-product entrant because it can allocate production across multiple formulations and negotiate portfolio contracts.

What is the Orange Book status of dextrose 10% and sodium chloride 0.2%?

The Orange Book is not the primary commercial reference for this product category. Orange Book value is limited because the product is not typically protected by a modern branded patent estate requiring Paragraph IV certification.

Paragraph IV and generic-entry risk

Paragraph IV litigation risk is generally low for a basic dextrose-sodium chloride solution because:

• The active ingredients are old.
• The formulation is conventional.
• There is no dominant branded innovator relying on patent exclusivity.
• Multiple generic or multisource products may already exist.
• Market entry is constrained more by sterile manufacturing capacity than by patent litigation.

A new applicant may still encounter FDA review issues, manufacturing inspections, facility remediation, labeling differences, or product-specific approval requirements. Those are regulatory execution risks, not classic patent barriers.

What generic launch scenarios exist?

Three commercial launch scenarios are most relevant.

Routine market entry

A new manufacturer enters with a conventional plastic-container presentation and competes through price, supply reliability, and contract access. This scenario produces limited pricing power.

Shortage-driven entry

A manufacturer enters or expands production after supply disruptions affect incumbent suppliers. FDA may use shortage-related measures to improve availability, but approval and quality requirements remain applicable. Shortage conditions can raise realized prices and accelerate hospital adoption [3].

Portfolio-led entry

A company launches dextrose 10% and sodium chloride 0.2% alongside sodium chloride 0.9%, dextrose 5%, lactated Ringer’s, and other hospital fluids. This approach is commercially stronger because hospitals prefer fewer suppliers and standardized procurement.

What patent litigation and settlement agreements affect the product?

No major product-specific patent litigation or settlement framework is expected to control market entry for this conventional IV solution. The relevant legal exposure is more likely to involve:

• Manufacturing defects.
• Product contamination.
• Labeling and packaging errors.
• Recall costs.
• Supply-contract disputes.
• Antitrust questions in hospital procurement.
• Regulatory enforcement involving current good manufacturing practices.

Because the formulation lacks a meaningful patent estate, litigation is unlikely to create a defined loss-of-exclusivity date or a scheduled generic cliff.

How does this product compare with other IV fluids?

Product	Primary commercial role	Differentiation	Pricing power
Dextrose 10%/sodium chloride 0.2%	Carbohydrate and electrolyte infusion	Narrow clinical niche	Low
Dextrose 5% in water	Basic carbohydrate and fluid source	Very limited	Low
Sodium chloride 0.9%	Broad fluid and electrolyte use	Very limited	Low
Dextrose 5%/sodium chloride 0.9%	Combined carbohydrate and sodium replacement	Established formulation	Low
Lactated Ringer’s	Balanced crystalloid replacement	Electrolyte composition	Low to moderate
Premixed drug infusions	Drug delivery and convenience	Formulation and delivery system	Higher

Dextrose 10% and sodium chloride 0.2% is more specialized than normal saline but less differentiated than premixed drug products or proprietary delivery systems. Its demand is therefore relatively dependable, while its price ceiling remains constrained.

What geographic markets matter?

The United States is a major market because of its large hospital system, high sterile-injectable consumption, and periodic IV-fluid shortages. Canada, Europe, Japan, Australia, and emerging markets also use comparable dextrose and sodium chloride solutions, but concentrations, container standards, reimbursement, and regulatory pathways differ.

Geographic expansion requires:

• Local product registration.
• Country-specific labeling.
• Approved manufacturing sites.
• Pharmacopoeial compliance.
• Import authorization.
• Temperature and distribution controls.
• Tender qualification.

The most attractive expansion strategy is usually regional manufacturing or a distributor partnership rather than a standalone product launch.

How strong is the commercial position of this product?

The product has low patent strength but moderate operational value.

Commercial strength scorecard

Category	Assessment
Patent protection	Very weak
Regulatory complexity	Moderate
Manufacturing complexity	Moderate to high
Demand predictability	Moderate to high
Price growth potential	Low
Shortage upside	High but episodic
Customer switching cost	Moderate during shortages, low under normal supply
Portfolio value	Moderate
Standalone investment appeal	Limited
Strategic value to a sterile-injectables platform	Meaningful

The central investment question is capacity and execution. A company with validated plastic-container manufacturing, reliable component suppliers, strong quality systems, and hospital contracts can earn stable returns. A company entering without scale is likely to face low margins and difficult procurement access.

What revenue exposure do manufacturers have?

Public filings generally do not report revenue for this exact formulation. Investors must use segment disclosures for hospital products, generic injectables, infusion therapy, or sterile manufacturing.

Product-level revenue can be estimated only through a bottom-up model using:

• Annual container volume.
• Average net selling price.
• Manufacturer share.
• Contract discounts.
• Distributor deductions.
• Shortage-related price changes.
• Product mix by container size.
• Geographic sales.

For a diversified manufacturer, the product is unlikely to be individually material unless the company has a narrow IV-fluid portfolio. For a smaller sterile-injectable supplier, a major hospital contract or manufacturing interruption can materially affect annual revenue.

Key Takeaways

• Dextrose 10% and sodium chloride 0.2% injection is a mature, multisource hospital IV product.
• Its commercial value is based on recurring demand and supply reliability, not patents.
• No meaningful product-specific patent expiration event or Paragraph IV litigation cliff is expected.
• The FDA pathway is generally abbreviated or legacy-based, with manufacturing quality as the principal regulatory barrier.
• Plastic-container production, sterility assurance, container integrity, and supply-chain execution determine profitability.
• Product-level revenue is generally not disclosed by manufacturers.
• Financial growth is likely to be modest under normal conditions, with temporary upside during shortages.
• The strongest commercial strategy is portfolio distribution across multiple IV fluids and hospital contracts.
• Biosimilar risk is irrelevant because the product is a chemically defined small-molecule injectable, not a biologic.
• Generic-entry risk is already realized, but capacity and procurement barriers limit practical competition.

FAQs

Is dextrose 10% and sodium chloride 0.2% a generic drug?

Yes. It is a conventional multisource intravenous solution, and its commercial market is generally supplied through generic or legacy sterile-product approvals.

Does this IV solution have a patent expiration date?

There is no commercially important formulation patent expected to establish a single loss-of-exclusivity date for the basic product.

Can hospitals substitute another IV fluid?

Clinical substitution depends on the patient’s glucose, sodium, fluid, osmolarity, and volume requirements. Hospitals may use other dextrose-saline concentrations or crystalloid products when clinically appropriate, but substitution requires medical and pharmacy review.

Is the product at risk from biosimilars?

No. Biosimilars apply to biological products. Dextrose and sodium chloride injection is a chemically defined sterile solution.

What is the biggest investment risk?

The main risk is operational: contamination, manufacturing shutdowns, plastic-container shortages, failed quality inspections, contract loss, or inadequate plant utilization. Patent litigation is not the primary risk.

References

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

2. National Library of Medicine. (n.d.). DailyMed: Current medication information. https://dailymed.nlm.nih.gov/dailymed/

3. U.S. Food and Drug Administration. (n.d.). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

4. U.S. Food and Drug Administration. (2016). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary. U.S. Pharmacopeial Convention.