List of Excipients in Branded Drug CARBON DIOXIDE OXYGEN MIXTURE 5/95

« Back to Dashboard

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
AGL Inhalation Therapy Co	CARBON DIOXIDE OXYGEN MIXTURE 5/95	carbon dioxide oxygen mixture 5/95	17575-020	CARBON DIOXIDE

Carbon Dioxide Oxygen Mixture 5/95: Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 14, 2026

A 5% carbon dioxide and 95% oxygen mixture is a medical gas combination, not a conventional formulation containing excipients. Carbon dioxide and oxygen are the active gases. The main commercial opportunities are supply reliability, cylinder and valve systems, validated blending, treatment-specific delivery protocols, and proprietary medical devices rather than new chemical composition claims.

The mixture’s patent position is likely weak at the composition level because carbon dioxide-oxygen blends have long-standing medical and industrial use. Commercial protection is more likely to arise from manufacturing controls, packaging, delivery equipment, dosing protocols, and narrowly defined therapeutic uses.

What is carbon dioxide oxygen mixture 5/95?

Carbon dioxide oxygen mixture 5/95, commonly described as 5% CO2 in 95% O2, is a premixed medical gas. It is sometimes associated with the term "carbogen," although carbogen formulations are not uniform. Some products use 5% carbon dioxide and 95% oxygen, while others use different carbon dioxide concentrations.

The mixture can produce two pharmacological effects:

• Oxygen increases inspired oxygen concentration.
• Carbon dioxide increases ventilatory drive and can cause controlled hypercapnic stimulation.

The intended clinical application determines whether the product is regulated as a drug, medical gas, device-associated product, or a combination of these categories. The gas concentration, pressure, cylinder configuration, delivery equipment, labeling, and clinical protocol all affect the regulatory pathway.

Does carbon dioxide oxygen mixture 5/95 contain excipients?

No conventional excipient is required. The formulation is a gas mixture consisting of two active components:

Component	Nominal concentration	Function
Carbon dioxide	5% v/v	Active respiratory and vascular stimulus
Oxygen	95% v/v	Active oxygen source and carrier gas

The product does not normally contain solvents, preservatives, stabilizers, surfactants, buffers, propellants, or solid carriers. Cylinder residual gases and trace impurities are controlled through manufacturing specifications rather than treated as formulation excipients.

What materials are relevant to product quality?

The commercial formulation depends on the gas-contact materials and container system. Relevant materials include:

• Gas cylinders, typically aluminum or steel
• Cylinder valves and regulators
• Pressure relief devices
• Medical-grade tubing
• Masks, hoods, ventilator interfaces, or breathing circuits
• Seals and elastomers
• Inline filters
• Flow meters and concentration monitors

These materials are not excipients. They are components of the container-closure and delivery system. Extractables, leachables, particulate contamination, moisture, hydrocarbon contamination, valve compatibility, and oxygen-cleaning controls require evaluation.

Oxygen-rich systems create elevated combustion risk. Equipment must be suitable for oxygen service, and the manufacturing process must control oils, greases, particulates, and incompatible elastomers.

What excipient strategy is appropriate for a 5/95 gas mixture?

The appropriate strategy is an excipient-free formulation strategy combined with a high-control container and delivery system.

Gas purity and impurity controls

The product specification should address:

• Carbon dioxide concentration
• Oxygen concentration
• Nitrogen and argon contamination
• Carbon monoxide
• Hydrocarbons
• Water vapor
• Particulates
• Cylinder residual gas
• Fill pressure
• Concentration uniformity
• Stability during storage and repeated use

A practical commercial specification should use validated analytical methods, including gas chromatography or calibrated gas analysis, with release testing tied to the labeled concentration.

Blend uniformity

The product can be manufactured by controlled partial-pressure filling, mass-flow blending, or validated sequential filling. The manufacturer should demonstrate that the concentration remains within specification:

• At initial release
• After cylinder storage
• At different cylinder fill levels
• During repeated dispensing
• Across the claimed temperature range
• After transport and handling

The mixture should not be treated like a simple bulk commodity if the intended use requires a precise inhaled concentration.

Container-closure strategy

The cylinder and valve system may provide greater commercial differentiation than the gas composition. Useful design features include:

• Integrated pressure regulation
• Tamper-evident valves
• Patient-specific flow control
• Low-residual-volume systems
• Portable cylinders
• Concentration verification at the outlet
• Lockout mechanisms preventing connection to incompatible equipment
• Digital pressure and usage monitoring

These features can support device patents, design protection, quality claims, and customer contracts even where composition patents are unavailable.

What regulatory status does carbon dioxide oxygen mixture 5/95 have?

In the United States, medical gases are regulated as drugs when they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. FDA rules address medical-gas current good manufacturing practice, labeling, establishment registration, and drug listing under 21 C.F.R. Part 213 and related provisions of the Federal Food, Drug, and Cosmetic Act.[1]

The regulatory status depends on the specific indication and marketing claims. A product sold only as a laboratory or industrial gas is treated differently from a product labeled for inhalation by patients.

FDA approval pathway

Potential pathways include:

Product position	Likely regulatory question
General medical gas for inhalation	Whether an approved drug application or recognized lawful marketing basis exists
Gas used with a ventilator or breathing system	Whether the product is a drug, device, or combination product
Gas used in a diagnostic challenge	Whether the labeled procedure requires FDA authorization
Gas used in a clinical trial	Whether an investigational application is required
Gas sold for research use only	Whether labeling avoids patient-treatment claims

FDA has recognized special regulatory issues for medical gases because they are manufactured, filled, stored, and distributed differently from conventional drug products.[1] The label must identify the gas composition, intended use, warnings, storage requirements, cylinder handling requirements, and delivery conditions.

What is the Orange Book status of carbon dioxide oxygen mixture 5/95?

A specific Orange Book listing cannot be assigned to the gas mixture without identifying the sponsor, proprietary product, application number, and approved labeling.

In general, a 5/95 gas mixture does not have the same Orange Book profile as a conventional small-molecule tablet or injectable. The key questions are:

• Whether a sponsor holds an approved NDA or ANDA
• Whether the product has a listed proprietary name
• Whether patents have been submitted for listing under FDA rules
• Whether the product is approved for a specific indication
• Whether a generic or 505(b)(2) pathway is available

Composition patents for a longstanding gas ratio would face substantial novelty and obviousness challenges. Orange Book value could instead arise from an approved method of use, a delivery system, or an approved formulation and container configuration. Those protections would need to satisfy FDA patent-listing requirements and applicable patent-law standards.

What patents protect carbon dioxide oxygen mixture 5/95?

The mixture itself is unlikely to support a strong modern composition-of-matter patent unless the claim includes a novel concentration range, impurity profile, storage condition, manufacturing process, or therapeutic result that is not disclosed in the prior art.

The strongest potential patent categories are:

Formulation and gas-composition patents

Possible claim elements include:

• A defined CO2 concentration range around 5%
• A specified oxygen concentration range
• Maximum impurity levels
• Controlled moisture content
• A defined gas mixture for a particular patient population
• A stability profile under specified pressure and temperature conditions

A claim covering only "5% carbon dioxide and 95% oxygen" would face prior-art and obviousness risks because medical carbogen mixtures and respiratory gas blends have been used for decades.

Method-of-use patents

Use claims may be more defensible if they are tied to:

• A defined treatment protocol
• A specific disease or patient subgroup
• A particular inhalation duration
• A controlled flow rate
• A preoxygenation or recovery sequence
• Combination use with another treatment
• A biomarker-defined response
• A specific delivery device

Method-of-use patents require clinical evidence that supports the claimed therapeutic benefit. A broad claim to inhaling the mixture for a general physiological effect would be vulnerable if the use is already established.

Manufacturing and filling patents

Manufacturing claims may address:

• Partial-pressure blending
• Sequential filling
• Automated concentration verification
• Low-contamination oxygen filling
• Cylinder evacuation and purge cycles
• Long-term concentration stability
• Mobile filling systems
• Automated cylinder traceability

These claims can create operational barriers, but they rarely prevent competitors from using alternative filling methods.

Delivery-system patents

A company may seek protection for:

• Flow-controlled masks
• Closed-loop concentration control
• Adaptive ventilation
• Portable respiratory challenge systems
• Integrated gas analyzers
• Dose tracking
• Safety interlocks
• Cylinder-to-device authentication

The delivery system can also create regulatory and switching costs. Its value increases when the gas is approved or validated for use only with a specific protocol or device.

When does carbon dioxide oxygen mixture 5/95 lose exclusivity?

There is no universal loss-of-exclusivity date for the 5/95 mixture. Exclusivity must be analyzed patent by patent and product by product.

Protection type	Commercial relevance
Composition patent	Likely limited if based only on the known gas ratio
Process patent	May restrict a particular filling method
Method-of-use patent	May restrict a labeled therapeutic indication
Device patent	May restrict a proprietary delivery system
Regulatory exclusivity	Depends on the approved application and FDA designation
Trade secret	Can protect blending controls, specifications, and manufacturing know-how
Contractual exclusivity	Can arise through hospital, distributor, or device agreements

A gas manufacturer may have no meaningful regulatory exclusivity even where it has a commercially valuable supply position. Medical-gas markets often rely on manufacturing licenses, cylinder fleets, hospital contracts, local production, and quality systems rather than long-lived molecule patents.

What commercial opportunities exist for excipient-free 5/95 gas?

The highest-value opportunities are infrastructure and workflow opportunities.

Respiratory stimulation and diagnostic testing

A controlled 5% CO2 mixture can be positioned for respiratory challenge protocols, ventilatory-response testing, and specialized pulmonary or neurological research. The commercial product should include calibrated delivery equipment and standardized operating procedures rather than a cylinder alone.

Hypercapnia and cerebrovascular research

CO2 inhalation is used in research involving cerebrovascular reactivity and respiratory physiology. A commercial package could combine:

• Medical gas
• Gas blender
• Flow controller
• End-tidal CO2 monitoring
• Oxygen monitoring
• Automated exposure timing
• Data export for clinical research

This package can command a higher price than bulk gas and may support device-related intellectual property.

Ophthalmic and vascular applications

Carbogen has been studied in retinal and vascular contexts, but a sponsor would need a clearly defined indication, dosing protocol, and clinical evidence. The opportunity is stronger when the product is paired with an approved or investigational therapeutic program.

Radiation and tumor-oxygenation research

Carbogen mixtures have been investigated to alter tissue oxygenation. Commercial use would depend on clinical evidence, institutional protocols, and regulatory authorization. The primary barrier is not excipient development. It is demonstrating a reproducible clinical benefit with controlled exposure.

Home-care and portable systems

Portable cylinders or compact gas-generation systems may support niche applications where transportability and monitoring matter. Safety engineering, reimbursement, oxygen-service certification, and patient adherence are central commercial issues.

How strong is the patent estate for carbon dioxide oxygen mixture 5/95?

The likely patent estate can be characterized as weak for the basic mixture and potentially moderate for integrated products.

Asset category	Expected strength	Main risk
Basic 5/95 composition	Low	Longstanding prior art
Narrow purity or stability profile	Low to moderate	Enablement and obviousness
Disease-specific method	Moderate	Clinical support and prior use
Automated delivery system	Moderate to strong	Device prior art and design-around
Manufacturing process	Moderate	Easy substitution of process
Cylinder and valve configuration	Moderate	Engineering alternatives
Trade secrets and quality system	Commercially meaningful	Employee and supplier leakage
Hospital supply contracts	Commercially meaningful	Limited duration and switching risk

The strongest competitive moat is likely to be a bundle of approved labeling, validated delivery hardware, safety data, hospital integration, dependable supply, and manufacturing compliance.

Which companies are likely to compete?

Competition is likely to come from three groups:

1. Large industrial-gas companies with cylinder infrastructure and hospital distribution.
2. Specialty medical-gas manufacturers serving regional healthcare systems.
3. Medical-device companies selling gas blenders, ventilators, respiratory monitors, and research platforms.

The competitive advantage will depend on cylinder logistics, fill-site location, regulatory history, quality consistency, device integration, and service contracts. A company with only the gas mixture and no delivery platform is likely to face price competition.

What generic entry risks exist?

Generic entry risk is structurally high if the product is marketed as a simple premixed gas without enforceable patents or regulatory exclusivity. Entry barriers may still arise from:

• FDA application requirements
• Medical-gas cGMP compliance
• Qualified fill plants
• Oxygen-compatible equipment
• Cylinder ownership and recertification
• Hospital vendor qualification
• Pharmacovigilance and complaint handling
• Validated concentration testing
• Clinical protocol acceptance

A competitor can often avoid composition claims by using the same concentration with a different cylinder, filling process, or device. This makes operational execution more important than molecule-level exclusivity.

How should a company build a commercial protection strategy?

A practical strategy should prioritize five layers:

1. Obtain appropriate regulatory status for a defined indication or clinical use.
2. Patent the delivery device, control algorithm, monitoring system, and treatment protocol.
3. Protect filling, impurity control, and stability methods as patents or trade secrets.
4. Establish hospital and research-site contracts that include equipment placement and recurring supply.
5. Create validated operating procedures that make the product easy to adopt and difficult to replace.

The commercial product should be sold as a controlled therapy or diagnostic platform, not as undifferentiated CO2 and oxygen.

Key Takeaways

• Carbon dioxide oxygen mixture 5/95 has no conventional excipients. Both gases are active ingredients.
• The core composition is likely difficult to protect with a strong modern composition patent.
• The most defensible intellectual property is likely to involve delivery devices, monitoring, manufacturing controls, and disease-specific methods of use.
• FDA status depends on the sponsor, indication, labeling, delivery system, and application type.
• Orange Book status cannot be inferred from the gas ratio alone.
• Generic entry risk is high for a commodity gas but lower for an integrated drug-device platform.
• Commercial value is most likely in validated supply, clinical protocols, portable delivery, and monitoring technology.
• A strong business model should combine medical-gas manufacturing with proprietary hardware, regulatory approvals, and institutional contracts.

FAQs

Is carbogen the same as carbon dioxide oxygen mixture 5/95?

Not always. "Carbogen" is a general term for carbon dioxide-oxygen mixtures, and different products may use different CO2 concentrations. The specific composition must be confirmed from the product label and certificate of analysis.

Can carbon dioxide oxygen mixture 5/95 be protected by a formulation patent?

A patent may be possible for a narrowly defined composition, purity profile, stability condition, or therapeutic use. A basic claim covering only 5% CO2 and 95% O2 would likely face substantial prior-art challenges.

Is a medical-gas cylinder an excipient?

No. The cylinder, valve, tubing, and mask are container-closure or delivery-system components. They are not excipients in the pharmaceutical formulation.

Could a 5/95 gas mixture qualify for a 505(b)(2) application?

Potentially, if the sponsor relies partly on existing FDA findings while proposing a new indication, delivery system, dosage regimen, or other change. The appropriate pathway depends on the reference product and proposed labeling.

What is the most valuable commercial innovation for this gas mixture?

An integrated system combining validated 5/95 gas, controlled delivery, end-tidal monitoring, automated dosing, safety interlocks, and clinical data capture is likely to create more value than the gas composition alone.

References

1. U.S. Food and Drug Administration. (2019). Current good manufacturing practice, quality system, and registration of human drug compounding outsourcing facilities and medical gases. 21 C.F.R. Part 213.

2. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2018). Medical gas containers and closures: Current good manufacturing practice guidance for industry. https://www.fda.gov/

4. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. General chapters concerning medical gases, oxygen, carbon dioxide, and container systems.

5. U.S. Food and Drug Administration. (2023). Approved drug products and regulatory information for medical gases. https://www.fda.gov/drugs/medical-gases/medical-gases-requirements-regulatory-information