List of Excipients in Branded Drug SODIUM CHLORIDE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Liebel-Flarsheim Company LLC	SODIUM CHLORIDE	sodium chloride	0019-1188	WATER
B Braun Medical Inc	SODIUM CHLORIDE	sodium chloride	0264-1800	HYDROCHLORIC ACID
B Braun Medical Inc	SODIUM CHLORIDE	sodium chloride	0264-1800	WATER
B Braun Medical Inc	SODIUM CHLORIDE	sodium chloride	0264-2201	HYDROCHLORIC ACID

Generic Drugs Containing SODIUM CHLORIDE

Company	Ingredient	NDC	Excipient
Henry Schein Inc	sodium chloride	0404-9955	HYDROCHLORIC ACID
Henry Schein Inc	sodium chloride	0404-9955	SODIUM HYDROXIDE
Henry Schein Inc	sodium chloride	0404-9978	HYDROCHLORIC ACID
Henry Schein Inc	sodium chloride	0404-9978	SODIUM HYDROXIDE

What are the Most Frequently-Used Excipients in SODIUM CHLORIDE?

# Of NDCs	Excipient
18	HYDROCHLORIC ACID
1	NITROGEN
13	SODIUM HYDROXIDE
31	WATER

Sodium Chloride Excipient Strategy, Patent Risk, and Commercial Opportunities

Last updated: August 14, 2026

Sodium chloride is a low-cost, globally available pharmaceutical excipient with limited molecule-level patent protection. Its commercial value comes from formulation design, sterile manufacturing, packaging, delivery devices, regulatory execution, and supply reliability rather than ownership of sodium chloride itself. The strongest opportunities are preservative-free sterile products, hypertonic saline, ophthalmic and nasal delivery, ready-to-use hospital formats, and differentiated container-closure systems.

What pharmaceutical functions does sodium chloride perform?

Sodium chloride is used as a tonicity agent, electrolyte, osmolality modifier, ionic-strength adjuster, and, in some formulations, a bulking or processing aid. The same material can be an active pharmaceutical ingredient in saline products and an inactive ingredient in products where another drug provides the therapeutic effect.

Function	Commercial use	Main technical objective
Tonicity adjustment	Parenteral, ophthalmic, nasal, and otic products	Match or approach physiological osmolality
Electrolyte replacement	Sodium chloride injections and oral rehydration products	Deliver sodium and chloride ions
Ionic-strength control	Biologics and protein formulations	Control solubility, aggregation, and protein interactions
Osmolality control	Inhalation and irrigation products	Adjust local or systemic tolerability
Bulking or process aid	Select solid or liquid formulations	Improve fill weight, handling, or manufacturing performance

Pharmaceutical sodium chloride must meet applicable compendial and quality requirements, generally including the USP-NF Sodium Chloride monograph and relevant national standards. Product specifications typically address identity, assay, impurities, microbial quality where applicable, endotoxins for parenteral use, and particulate contamination.[1]

Sodium chloride concentration also determines product positioning:

Concentration	Sodium chloride content	Approximate osmolality	Common applications
0.45%	4.5 mg/mL	154 mOsm/L	Hypotonic fluid replacement
0.9%	9 mg/mL	308 mOsm/L	Isotonic saline, dilution, flushing
3%	30 mg/mL	1,026 mOsm/L	Hypertonic saline, selected respiratory and hospital uses
5%	50 mg/mL	1,711 mOsm/L	Specialized hypertonic applications
23.4%	234 mg/mL	Approximately 8,000 mOsm/L	Concentrated hospital electrolyte use

The calculation assumes complete dissociation of sodium chloride into sodium and chloride ions. Actual product osmolality depends on formulation, temperature, measurement method, and other ingredients.

What pharmaceutical products use sodium chloride as an excipient?

Sodium chloride appears across several dosage forms and therapeutic categories.

Injectable and infusion products

Sodium chloride is widely used in large-volume parenterals, small-volume injections, flush syringes, diluents, and electrolyte replacement products. In a 0.9% Sodium Chloride Injection product, sodium chloride is generally the active ingredient. In other injectable products, it may be an inactive ingredient used to adjust tonicity.

The commercial product categories include:

• 0.9% sodium chloride injection in flexible bags, glass bottles, and plastic bottles
• 0.45% and 0.225% sodium chloride injections
• 3% and 5% hypertonic saline
• Sodium chloride flush syringes
• Sterile diluents for reconstitution
• Sodium chloride-containing premixes
• Small-volume parenteral products
• Irrigation and surgical lavage products

The principal manufacturing barriers are sterile fill-finish capacity, container-closure integrity, endotoxin control, particulate control, and validated sterilization. The underlying formulation is usually simple, but the quality system and supply chain requirements are demanding.

Ophthalmic products

Sodium chloride is used in artificial tears, ophthalmic irrigation, hypertonic ophthalmic solutions, contact-lens products, and other eye-care products. Commercial differentiation often depends on:

• Preservative-free single-dose packaging
• Multidose systems with antimicrobial barriers
• Low-particulate filling
• Improved drop-size consistency
• Compatibility with contact lenses
• Reduced stinging through optimized pH and osmolality
• Unit-dose blow-fill-seal packaging

In ophthalmic products, sodium chloride is rarely the primary intellectual-property asset. The more defensible assets are delivery devices, preservative systems, sterile packaging, viscosity modifiers, and claims directed to a specific clinical use.

Nasal and inhalation products

Sodium chloride is used in isotonic and hypertonic nasal sprays, nebulized solutions, nasal irrigation products, and respiratory-care products. The commercial opportunity is strongest where the product combines saline with a differentiated delivery format.

Potentially defensible product features include:

• Metered-dose nasal pumps
• One-way valves and contamination-resistant designs
• High-volume nasal irrigation systems
• Unit-dose nebulizer containers
• Particle-size control for inhaled products
• Preservative-free multidose systems
• Ready-to-use sterile respiratory solutions

For nasal products, the device can account for more practical differentiation than the saline composition. For inhalation products, aerosol performance, container compatibility, microbial control, and nebulizer interaction are central development issues.

What excipient strategy is strongest for sodium chloride products?

A sodium chloride excipient strategy should begin with the target route, required osmolality, packaging format, and regulatory pathway. The lowest-cost strategy is a conventional aqueous solution in a standard container. The highest-value strategy combines saline with a device, sterile presentation, clinical-use claim, or manufacturing advantage.

Strategy 1: Use sodium chloride as a formulation enabler

For biologics, peptides, and sensitive injectables, sodium chloride can affect protein solubility, aggregation, adsorption, viscosity, and freeze-thaw behavior. The formulation team should evaluate sodium chloride against alternatives such as sucrose, trehalose, mannitol, arginine, phosphate, histidine, and other buffering or tonicity systems.

Critical studies include:

• Protein aggregation under accelerated and long-term conditions
• Subvisible and visible particulate formation
• Adsorption to glass, elastomer, and polymer surfaces
• Freeze-thaw and shipping stress
• Container-closure compatibility
• Osmolality and pH drift
• Interaction with surfactants and buffers

Sodium chloride can reduce formulation complexity, but it is not universally preferred. High ionic strength can destabilize some proteins or increase sensitivity to interfaces and temperature changes.

Strategy 2: Develop preservative-free formats

Preservative-free products command a commercial premium in several hospital, ophthalmic, and respiratory categories. Single-dose ampoules, blow-fill-seal units, and prefilled syringes can reduce preservative exposure and simplify administration.

The tradeoff is higher packaging cost, more complex filling operations, and greater dependence on sterile manufacturing capacity. A preservative-free claim must be supported by microbial, sterility, container-closure, and in-use studies appropriate to the dosage form.

Strategy 3: Pair saline with a device

Device integration creates stronger differentiation than sodium chloride concentration alone. Relevant assets include:

• Prefilled flush syringes
• Closed-system transfer devices
• Metered nasal sprays
• Nebulizer-compatible unit doses
• Contamination-resistant irrigation systems
• Pump designs that control delivered volume
• Packaging that improves portability or reduces waste

Device patents can create a meaningful barrier even when the saline formulation is unpatented. Regulatory classification depends on whether the device is marketed as part of a drug-device combination product or as a separate accessory.

Strategy 4: Optimize the supply chain

Sodium chloride is inexpensive, but sterile saline products can experience supply constraints because of manufacturing outages, transport issues, packaging shortages, and hospital demand spikes. Commercial value can come from:

• Dual qualified sodium chloride suppliers
• Regional sterile manufacturing
• Multiple container sizes
• Flexible bag and bottle platforms
• Redundant blow-fill-seal lines
• Validated alternative packaging components
• Inventory policies for hospital-critical SKUs

The key asset is often manufacturing resilience rather than the raw material itself.

What patents protect sodium chloride pharmaceutical products?

Core sodium chloride composition patents are generally weak because sodium chloride is an established chemical substance with long-standing pharmaceutical use. Patent protection usually focuses on a specific formulation, delivery system, manufacturing method, or use.

Patent category	Potential scope	Relative strength
Sodium chloride composition	Concentration, pH, buffer, co-solvent, or combination	Low to moderate
Ophthalmic formulation	Osmolality, viscosity, preservative-free system, comfort profile	Moderate
Nasal delivery	Pump, valve, dosing, contamination control	Moderate to strong
Inhalation product	Aerosol characteristics, nebulizer compatibility, packaging	Moderate
Injectable container	Syringe, bag, port, stopper, closure, overwrap	Moderate
Manufacturing process	Sterilization, filling, mixing, inspection, packaging	Moderate if difficult to design around
Method of use	Hypertonic saline or saline irrigation for a defined condition	Variable
Combination product	Saline plus active drug or device	Moderate to strong

A patent owner must claim more than the use of sodium chloride at a conventional concentration. Claims directed only to a routine saline concentration may face novelty, obviousness, enablement, or written-description challenges. Stronger claims may require a specific excipient combination, measurable performance characteristic, device architecture, or clinical result.

Patent expiration cannot be assigned to "sodium chloride" as a molecule. Expiration dates are asset-specific and depend on the patent family, priority date, patent-term adjustment, patent-term extension, disclaimers, terminal disclaimers, and jurisdiction.

How many patents cover sodium chloride excipient use?

There is no meaningful single count for patents covering sodium chloride as an excipient. A search may return thousands of documents because sodium chloride appears in claims, examples, specifications, and background disclosures across unrelated products.

A commercially useful patent analysis should separate:

1. Claims that require sodium chloride as a limitation.
2. Claims covering a broader formulation in which sodium chloride is optional.
3. Claims directed to a device used with saline.
4. Method-of-use claims involving saline concentration or administration.
5. Manufacturing and packaging claims.
6. Expired, abandoned, canceled, or nonenforced claims.
7. Patent families that cover the same commercial product.

The relevant unit for freedom-to-operate analysis is the live claim set, not the number of documents mentioning sodium chloride.

What is the FDA regulatory status of sodium chloride products?

Sodium chloride products are regulated according to dosage form, route, intended use, concentration, labeling, and product composition. FDA-approved sodium chloride injections and related saline products appear in FDA databases and in product labeling repositories such as DailyMed.[2][3]

For a conventional saline product, the likely regulatory routes include:

• ANDA for a therapeutically equivalent generic product
• 505(b)(2) NDA for a product relying partly on existing information but introducing differences
• Full NDA where the product has a novel active-drug combination or clinical positioning
• OTC pathways for certain consumer saline products, depending on intended use and applicable requirements
• Drug-device combination review for integrated delivery systems

The route should be determined by the product’s active ingredient status. A saline injection in which sodium chloride is the active ingredient is treated differently from an injectable drug that contains sodium chloride only as an inactive ingredient.

FDA Inactive Ingredient Database considerations

The FDA Inactive Ingredient Database is a central starting point for assessing prior excipient use by route and dosage form.[4] Prior listing does not automatically establish approval for every concentration, route, or product configuration. The development team must evaluate:

• Route-specific precedent
• Maximum prior quantity or concentration
• Dosage form
• Pediatric and vulnerable-patient exposure
• Intended duration of use
• Local tolerability
• Product-specific impurities and microbial controls

For parenteral and ophthalmic products, route precedent and quality attributes are particularly important.

What is the Orange Book status of sodium chloride products?

The Orange Book lists approved drug products and, for applicable products, patent and exclusivity information.[5] Sodium chloride does not have a single Orange Book position. Each listed product has its own application number, sponsor, dosage form, strength, therapeutic-equivalence status, and any associated patent certifications.

For standard saline products, commercial competition is generally driven by approved ANDAs, manufacturing scale, hospital contracts, and supply reliability. An Orange Book listing should be reviewed at the individual product level for:

• NDA or ANDA status
• Reference listed drug designation
• Therapeutic-equivalence codes
• Listed patents
• Patent-use codes
• Exclusivity periods
• Approval supplements
• Discontinued-product status

A product may have no meaningful listed patent barrier even when the formulation or packaging is commercially differentiated.

When does sodium chloride lose exclusivity?

Sodium chloride itself has no modern compound exclusivity timeline. Product exclusivity depends on the applicable FDA approval and the protected innovation.

Potential exclusivity categories include:

Exclusivity type	Relevance
New chemical entity exclusivity	Generally not relevant to established sodium chloride
Three-year exclusivity	May apply to certain new clinical investigations supporting an approval or supplement
Orphan-drug exclusivity	Possible only for a qualifying orphan indication
Pediatric exclusivity	Adds six months to qualifying listed exclusivity or patent terms
Patent protection	Applies only to specific formulation, use, device, or manufacturing claims
Regulatory exclusivity outside the U.S.	Depends on jurisdiction and product category

For a conventional saline ANDA, generic entry risk is usually high unless the reference product has live formulation, use, or device patents that are listed and enforceable.

What Paragraph IV challenges affect sodium chloride products?

Paragraph IV risk is product-specific. An ANDA applicant may certify that a listed patent is invalid, unenforceable, or will not be infringed. If the reference product has listed patents, a Paragraph IV certification can trigger litigation and, in some circumstances, a 30-month stay under the Hatch-Waxman framework.[6]

For sodium chloride products, Paragraph IV exposure is more likely where the product includes:

• A proprietary device
• A novel container-closure system
• A concentrated or combination formulation
• A specific method of use
• A patented sterile manufacturing process
• A formulation with a defined performance characteristic

A plain 0.9% saline solution in a conventional bag has limited structural protection. A prefilled saline flush syringe with proprietary geometry or a contamination-control mechanism has a more credible patent challenge profile.

What method-of-use patents protect saline products?

Method-of-use patents may cover hypertonic saline, saline irrigation, respiratory administration, wound care, ophthalmic treatment, or use with a specific device. Their value depends on claim breadth, clinical evidence, labeling, and the ability of a generic applicant to omit the patented indication.

A generic applicant may use a skinny-label strategy when the patented use can be carved out without removing nonprotected uses. This limits the reference sponsor’s ability to block all generic sales. Method-of-use patents are stronger when the protected use dominates the product’s market and cannot be practically separated from the approved label.

Are there biosimilar risks for sodium chloride?

Sodium chloride has no biosimilar risk because it is a small-molecule inorganic compound, not a biologic. Competitive risk arises from:

• ANDA-approved generics
• Authorized generics
• Private-label saline
• Hospital-compounded products
• Imported or regionally manufactured saline
• Device-equivalent products
• Contract manufacturing expansion

Biologic products that contain sodium chloride as an excipient may face biosimilar competition, but the biosimilar risk attaches to the biologic active ingredient, not to sodium chloride.

Which companies compete in sodium chloride products?

Competition varies by region and dosage form. Major categories include large parenteral manufacturers, generic injectable companies, hospital-supply companies, ophthalmic specialists, respiratory-product manufacturers, and private-label suppliers.

Representative commercial participants in saline and sterile injectable markets have included Baxter, B. Braun, Fresenius Kabi, Pfizer, ICU Medical, and regional generic manufacturers. The relevant competitive comparison is SKU-specific rather than molecule-specific.

Competitive factor	Strategic significance
Sterile capacity	Determines ability to serve hospital demand
Bag and bottle portfolio	Expands tender eligibility
Prefilled syringe capability	Supports higher-value convenience products
Regulatory history	Affects procurement confidence
Shortage performance	Influences hospital switching
Device ownership	Creates differentiation and patent leverage
Geographic manufacturing	Reduces logistics and disruption risk
Contract pricing	Often determines share in mature markets

What commercial opportunities exist for sodium chloride?

The most attractive opportunities are products where saline is part of a differentiated platform.

Hospital and critical-care products

Opportunities include ready-to-use flush syringes, smaller-volume bags, hypertonic saline, emergency-use concentrations, and products designed to reduce preparation steps. Hospitals value availability, standardized labeling, low particulate burden, and compatibility with automated dispensing systems.

Ophthalmic and nasal consumer products

Preservative-free unit doses, premium nasal irrigation systems, and ergonomic delivery devices can support higher margins than bulk saline. The commercial proposition should focus on convenience, sterility, dosing consistency, and tolerability.

Respiratory care

Nebulizer-ready unit doses and hypertonic saline products may benefit from respiratory-care growth and home-use expansion. Device compatibility and particle-size performance are central commercialization issues.

Emerging markets

In lower-income and supply-constrained markets, the opportunity is often local sterile manufacturing and reliable distribution rather than premium formulation innovation. Regional packaging, smaller fill volumes, and local tender participation can improve economics.

Contract manufacturing

Sodium chloride products are suitable for platform manufacturing because multiple concentrations and presentations can be produced from related processes. A contract manufacturer with validated sterile lines, flexible packaging, and established regulatory files can sell capacity to hospitals, generic sponsors, and consumer-health companies.

How strong is the patent estate for sodium chloride?

The patent estate is weak at the ingredient level and potentially moderate or strong at the product-system level.

Weak protection

• Conventional 0.9% saline
• Standard sodium chloride concentration ranges
• Routine use as a tonicity agent
• Generic infusion bags using established materials
• Broad claims without measurable performance limits

Stronger protection

• Proprietary delivery devices
• Preservative-free multidose systems
• Specialized container-closure technology
• Combination products with a therapeutic active
• Narrow clinical-use claims supported by data
• Manufacturing processes that produce a demonstrated quality advantage

Commercial diligence should focus on claim construction, prosecution history, continuation activity, patent-term status, and design-around options. A large patent family does not necessarily indicate a strong blocking position.

What manufacturing and intellectual-property barriers affect sodium chloride?

The primary barriers are operational:

• Sterile processing and aseptic assurance
• Endotoxin removal and control
• Particulate reduction
• Container-closure integrity
• Extractables and leachables
• Low-temperature or terminal sterilization validation
• High-volume fill accuracy
• Packaging-component supply
• Regulatory change control
• Distribution under controlled conditions

For bags and plastic containers, materials selection can affect oxygen transmission, moisture loss, drug adsorption, seal integrity, and leachables. For prefilled syringes, silicone oil, stopper compatibility, break-loose force, and dose accuracy require testing. USP <1207> provides a framework for container-closure integrity evaluation.[7]

Key Takeaways

• Sodium chloride has little practical molecule-level patent value.
• Commercial protection comes from formulation combinations, devices, packaging, manufacturing, and use claims.
• The strongest opportunities are preservative-free sterile products, hypertonic saline, saline flush syringes, respiratory unit doses, and differentiated ophthalmic or nasal systems.
• Standard 0.9% saline is a highly competitive, price-sensitive category.
• FDA status, Orange Book exposure, and Paragraph IV risk must be assessed by product and application number.
• Sodium chloride has no biosimilar risk.
• Sterile capacity, quality systems, packaging resilience, and hospital supply reliability often matter more than composition patents.
• Revenue exposure is driven by product SKUs, hospital contracts, and manufacturing capacity, not by ownership of sodium chloride as a substance.

FAQs

Can sodium chloride be patented as a pharmaceutical excipient?

A conventional use of sodium chloride as a tonicity agent is unlikely to provide strong patent protection. Patentability is more credible for a specific formulation, device, manufacturing method, or clinical use with technical evidence.

Is 0.9% sodium chloride a generic drug?

0.9% sodium chloride injection is marketed by multiple sponsors, including generic manufacturers. Whether a specific product is an ANDA, NDA, or another regulated presentation depends on its FDA application and labeling.

Does sodium chloride require an excipient master file?

A master file may support confidential information about manufacturing or quality controls, but its use depends on the sponsor’s regulatory strategy. The product application remains responsible for demonstrating that the excipient is suitable for its intended route and dosage form.

Can sodium chloride be used in biologic formulations?

Yes. Sodium chloride is used in some biologic formulations to adjust tonicity or ionic strength. Its suitability depends on protein stability, aggregation, adsorption, osmolality, and container compatibility.

What is the main generic-entry risk for saline products?

The main risk is rapid entry by multiple ANDA sponsors for conventional formulations. Patent-based delay is more plausible for products with proprietary devices, specialized packaging, combination formulations, or narrow method-of-use claims.

References

1. United States Pharmacopeial Convention. (2024). Sodium chloride monograph. In United States Pharmacopeia and National Formulary (USP-NF).
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
3. National Library of Medicine. (n.d.). DailyMed: Current medication information. https://dailymed.nlm.nih.gov/dailymed/
4. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
6. U.S. Food and Drug Administration. (2015). 210.26: Patent certifications and notification of ANDA applicants. In Code of Federal Regulations, Title 21.
7. United States Pharmacopeial Convention. (2024). <1207> Package integrity evaluation. In United States Pharmacopeia and National Formulary (USP-NF).