List of Excipients in Branded Drug SUPRANE

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SUPRANE (Desflurane) Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: October 7, 2026

SUPRANE is a legacy inhalation anesthetic containing desflurane as the active pharmaceutical ingredient and no added excipients. Its commercial opportunity is therefore not based on novel excipient claims. The strongest opportunities are supply reliability, vaporizer compatibility, packaging, container-closure performance, hospital contracts, and differentiated low-waste delivery systems. Desflurane’s mature regulatory profile and limited patent barriers support generic or private-label competition, although environmental restrictions and declining use in some markets reduce demand.

What is the SUPRANE formulation?

SUPRANE is a liquid for inhalation containing desflurane, USP. The product is administered through a calibrated vaporizer that converts the volatile liquid into an inhaled anesthetic vapor. The FDA prescribing information identifies desflurane as the active ingredient and does not identify preservatives, stabilizers, solvents, antioxidants, buffers, or other formulation excipients.[1]

Product attribute	SUPRANE position
Active ingredient	Desflurane
Dosage form	Liquid for inhalation
Route	Inhalation through a vaporizer
Concentration	100% desflurane, USP
Added excipients	None identified in the FDA label
Primary delivery system	Heated, calibrated anesthesia vaporizer
Original FDA approval	1992
Product category	Volatile general anesthetic
Primary commercial buyers	Hospitals, ambulatory surgery centers, anesthesia departments

Desflurane is chemically stable under normal storage conditions and has a boiling point near room temperature. The formulation does not depend on an aqueous vehicle or excipient system. The vaporizer, bottle, adapter, and closure are functionally important parts of the product system.

What excipients are used in SUPRANE?

SUPRANE contains no conventional formulation excipient. Its excipient strategy is a zero-excipient strategy.

This differs from many injectable, oral, and biologic products that require solubilizers, surfactants, preservatives, tonicity agents, antioxidants, or pH modifiers. For desflurane, adding such materials could create safety, volatility, vaporizer-calibration, residue, or inhalation-toxicity problems.

Why does SUPRANE not need stabilizers or preservatives?

Desflurane is a neat volatile liquid that is dispensed from a sealed container into an anesthesia vaporizer. The product is not intended to support microbial growth because it contains no aqueous phase. A preservative system would provide little commercial benefit and could introduce regulatory risk.

The FDA label instructs that SUPRANE should be stored at controlled room temperature and protected from conditions that could compromise container integrity or product handling.[1] The formulation’s quality strategy centers on identity, assay, impurities, water content, container compatibility, and vaporizer delivery rather than excipient uniformity.

Can excipients be added to desflurane?

A new excipient-containing desflurane product would likely be treated as a materially different formulation. The sponsor would need to establish:

• Compatibility with the vaporizer and delivery pathway.
• Absence of harmful decomposition products.
• Consistent delivered concentration.
• No clinically relevant impact on induction, maintenance, recovery, or respiratory safety.
• Stability under storage and repeated handling.
• Compatibility with bottle materials, closures, adapters, and seals.
• Acceptable extractables and leachables profile.
• No interference with anesthesia-machine sensors or scavenging systems.

The clinical value proposition would need to justify the additional development burden. A formulation change that does not reduce waste, improve handling, extend shelf life, or address a documented safety problem would have limited commercial value.

What patents protect SUPRANE and desflurane?

The core SUPRANE formulation is unlikely to have an active U.S. composition-of-matter patent barrier. Desflurane was approved in the early 1990s, placing any original U.S. patent term associated with the active ingredient or basic pharmaceutical use well before the current market period under the standard 20-year patent term framework.[2]

The relevant protection categories are:

Protection category	Commercial relevance for SUPRANE
Desflurane composition patent	Expected to be expired
Basic anesthetic-use patent	Expected to be expired
Formulation patent	No added-excipient formulation identified in the FDA label
Vaporizer technology	May be protected by separate device patents
Bottle and closure design	Potentially protected through packaging or device rights
Manufacturing process	May be protected as trade secrets or process patents
Method-of-use patent	Limited value for a mature general-anesthesia indication
Trademark	SUPRANE brand rights may remain separate from patent rights

FDA Orange Book listings, if present for a specific NDA record, must be assessed independently from patents covering anesthesia machines, vaporizers, adapters, or manufacturing equipment.[3] A device patent does not automatically block a desflurane drug product that is compatible with an alternative legally marketed vaporizer.

How strong is the SUPRANE patent estate?

The drug-product patent estate is weak compared with newer specialty pharmaceuticals. The commercial barriers are operational rather than patent-based:

1. Reliable production of pharmaceutical-grade desflurane.
2. Qualified suppliers for fluorinated raw materials.
3. Specialized filling and sealing equipment.
4. Vaporizer and anesthesia-machine compatibility.
5. Hospital formulary access.
6. Environmental procurement restrictions.
7. Regulatory compliance for volatile anesthetic manufacturing and distribution.

These barriers can protect pricing and supply relationships even when the active pharmaceutical ingredient is off patent.

When does SUPRANE lose exclusivity?

SUPRANE’s primary regulatory and patent exclusivity periods expired years ago. The product was approved in 1992, and the five-year new chemical entity exclusivity period under the Hatch-Waxman framework would have ended in 1997 if applicable.[2] Any original patent protection would generally have ended no later than the relevant statutory patent term, subject to patent-specific filing and extension dates.

The product therefore operates in a mature market. Current commercial protection depends on brand recognition, supply continuity, manufacturing capability, device integration, and contracting rather than regulatory exclusivity.

What is the FDA regulatory status of SUPRANE?

SUPRANE is an FDA-approved prescription inhalation anesthetic. Its labeling covers induction and maintenance of general anesthesia in adults and induction and maintenance in pediatric patients under specified conditions.[1]

The FDA label also identifies important handling and safety considerations, including malignant hyperthermia risk, respiratory effects, cardiovascular effects, and interactions with other anesthetic agents. These clinical risks create a high documentation burden for any reformulated or alternative desflurane product.

Is SUPRANE listed in the Orange Book?

The relevant FDA Orange Book analysis is the NDA record for SUPRANE rather than the trademark alone. Orange Book entries can identify approved products, dosage forms, therapeutic equivalence information, and listed patents or exclusivity where applicable.[3]

For commercial diligence, an applicant should distinguish:

• The NDA holder from the current manufacturer.
• The SUPRANE brand from generic desflurane products.
• Drug patents from vaporizer-device patents.
• Active listings from expired historical listings.
• Patent listings from regulatory exclusivity.

A mature desflurane product would generally present limited Orange Book patent risk compared with recently approved drugs. The main diligence question is whether any current listed patent remains relevant to the proposed product, not whether historical desflurane patents existed.

What generic entry risks exist for SUPRANE?

Generic entry risk is structurally high because the product has no complex excipient formulation and no extended-release delivery system. A competing manufacturer can pursue a conventional liquid inhalation product using the same active ingredient, subject to FDA quality, equivalence, labeling, and manufacturing requirements.

The main entry risks are:

Risk	Impact
Price competition	High
Hospital conversion	Moderate to high
Supply interruption	High for a limited supplier base
Vaporizer incompatibility	High if presentation differs
Environmental restrictions	High in selected health systems
Manufacturing failure	High because volatile anesthetic production is specialized
Patent litigation	Low relative to branded small-molecule drugs
Regulatory delay	Moderate

A generic launch could use a 505(b)(2) or abbreviated pathway depending on the product design and applicable FDA requirements. A conventional product with the same active ingredient, route, dosage form, strength, and labeling profile would generally be positioned around abbreviated approval, while material delivery-system differences could increase regulatory complexity.[4]

Which companies are challenging or competing with SUPRANE?

Competition comes from two groups: alternative desflurane suppliers and other volatile or intravenous anesthetics.

Desflurane competition

The competitive set may include generic desflurane products, private-label suppliers, and regional manufacturers. Market participation is affected by manufacturing capacity and hospital tenders more than by consumer brand preference.

Therapeutic competition

Product	Active ingredient	Competitive relationship
SUPRANE	Desflurane	Reference product
Sevoflurane products	Sevoflurane	Closest volatile-anesthetic substitute
Isoflurane products	Isoflurane	Lower-cost volatile alternative
Propofol products	Propofol	Intravenous alternative for induction and maintenance
Total intravenous anesthesia	Multiple agents	Substitute anesthesia technique

Sevoflurane competes directly with desflurane in operating rooms because it has different handling, induction, recovery, airway, and environmental characteristics. Hospital decisions often depend on procedure type, patient population, anesthesia preference, operating-room workflow, acquisition cost, and sustainability policy.

What formulation and packaging opportunities exist for SUPRANE?

The strongest product-development opportunities are outside the liquid formulation itself.

Improved container-closure systems

Potential improvements include:

• Lower-permeability bottle materials.
• More reliable seals and crimp systems.
• Integrated transfer adapters.
• Tamper-evident closures.
• Reduced residual volume.
• Better resistance to breakage during transport.
• Clearer fill-level markings.
• Packaging optimized for automated inventory control.

Any new closure or adapter must maintain chemical compatibility and prevent leakage of a volatile fluorinated anesthetic.

Vaporizer-compatible presentations

A supplier could differentiate through:

• Broad compatibility with installed anesthesia machines.
• Reduced transfer steps.
• Preconfigured adapters.
• Barcoded bottles linked to inventory systems.
• Packaging designed for rapid operating-room exchange.
• Lower residual product after vaporizer filling.

These features may support hospital contracts even when the liquid drug itself is chemically identical to competitors’ products.

Waste-reduction systems

Desflurane has a relatively high global-warming potential compared with some other anesthetic gases. Health systems increasingly evaluate anesthetic choice, fresh-gas flow, capture technologies, and operating-room emissions.[5]

A commercial platform could combine desflurane supply with:

• Low-flow anesthesia protocols.
• Vaporizer optimization.
• Waste-anesthetic capture.
• Emissions monitoring.
• Usage dashboards.
• Procurement reporting.

The opportunity is more defensible as a systems offering than as an excipient claim.

What manufacturing and intellectual-property barriers affect SUPRANE?

Desflurane manufacturing requires controlled fluorinated chemistry, impurity management, distillation or purification, and validated filling operations. The active ingredient must meet pharmaceutical quality standards while remaining compatible with the container and vaporizer.

Potentially defensible assets include:

• Process-control methods.
• Purification methods.
• Low-impurity manufacturing routes.
• Container-closure assemblies.
• Leak-detection systems.
• Vaporizer interfaces.
• Anesthesia-machine integration software.
• Waste capture and destruction systems.

Process know-how may be more valuable than a conventional formulation patent. Trade-secret protection can be important where manufacturing parameters are difficult to reverse engineer.

What licensing deals could create commercial value?

Licensing opportunities are more likely to involve devices and supply infrastructure than excipients. Potential structures include:

1. A drug manufacturer licensing a vaporizer adapter from an anesthesia-equipment company.
2. A regional desflurane supplier licensing pharmaceutical-grade active ingredient from a qualified producer.
3. A hospital-distribution company obtaining private-label rights.
4. A manufacturer partnering with a waste-anesthetic capture provider.
5. A drug supplier integrating its product with operating-room inventory software.
6. A device company licensing packaging technology that reduces product loss.

A conventional excipient license has limited strategic value because SUPRANE does not depend on an excipient system. A device or packaging license could create stronger differentiation and customer lock-in.

What is the revenue exposure and commercial outlook for SUPRANE?

Revenue exposure is concentrated in institutional purchasing. The product does not have a large retail channel, and sales depend on operating-room volume, anesthesia protocols, hospital contracts, and supply reliability.

Revenue is exposed to:

• Reduced use of desflurane because of environmental policy.
• Conversion to sevoflurane or intravenous anesthesia.
• Generic price erosion.
• Hospital group purchasing negotiations.
• Operating-room procedure volumes.
• Product shortages or manufacturing interruptions.
• Restrictions on high-global-warming anesthetic gases.

A supplier can reduce revenue pressure through contract reliability, differentiated packaging, workflow integration, and environmental services. Pure brand-based pricing is less sustainable in a mature hospital product category.

How does SUPRANE compare with sevoflurane?

Factor	Desflurane/SUPRANE	Sevoflurane
Formulation	Neat volatile liquid	Neat volatile liquid
Added excipients	None identified	No conventional excipient system
Delivery	Calibrated vaporizer	Calibrated vaporizer
Formulation IP opportunity	Low	Low to moderate
Device opportunity	High	High
Generic competition	High	High
Environmental pressure	High	Lower than desflurane in many assessments
Main differentiation	Workflow, supply, vaporizer integration	Patient handling, workflow, environmental profile

The strategic implication is direct: a SUPRANE-focused business should not center on novel excipients. It should center on reliable supply, packaging, delivery equipment, and environmental controls.

What is the generic launch and litigation outlook?

A generic entrant would face limited composition or formulation patent exposure but would still need to manage FDA approval, manufacturing validation, labeling, product liability, and supply-chain qualification. Paragraph IV litigation is less likely to be the central barrier for a mature desflurane product than it is for a recently approved drug with active Orange Book patents.

Potential litigation could instead involve:

• Trade-secret claims over manufacturing processes.
• Patent disputes involving vaporizer adapters.
• Packaging and closure patents.
• Trademark disputes involving SUPRANE branding.
• Product-liability claims relating to anesthesia delivery.
• Contract disputes with hospitals or distributors.

Settlement agreements are therefore more likely to concern supply, distribution, trademark coexistence, or device access than delayed generic entry under a patent settlement.

Key Takeaways

• SUPRANE contains desflurane and no identified conventional excipients.
• Its commercial value does not depend on a complex formulation.
• Original composition and basic-use patent protection is expected to be expired.
• Orange Book and patent risk should focus on current listings, device rights, and packaging claims.
• Generic entry risk is high, but qualified manufacturing capacity limits practical competition.
• The strongest commercial opportunities are vaporizer compatibility, container-closure systems, supply reliability, waste reduction, and operating-room workflow integration.
• Environmental restrictions are a material threat to long-term desflurane demand.
• Licensing opportunities are more attractive in devices, packaging, capture systems, and software than in excipients.

FAQs

Does SUPRANE contain preservatives?

No. The FDA labeling identifies desflurane as the drug substance and does not list preservatives or other conventional formulation excipients.[1]

Can a company patent a new SUPRANE excipient formulation?

Yes, if the formulation is novel, nonobvious, useful, and supported by adequate data. The commercial case would require a measurable benefit because the existing product already uses a simple neat-liquid formulation.

Are desflurane vaporizer adapters patentable?

Potentially. A novel adapter, transfer mechanism, or container-vaporizer interface may qualify for patent protection if it satisfies applicable patentability standards and is adequately described.

Is SUPRANE interchangeable with sevoflurane?

No. Both are volatile inhaled anesthetics, but they are different active ingredients with distinct clinical, operational, environmental, and labeling profiles. Substitution is a clinical and institutional decision, not automatic pharmaceutical interchangeability.

What is the best commercial strategy for a SUPRANE competitor?

The strongest strategy is a reliable, FDA-compliant desflurane supply paired with compatible packaging, broad vaporizer support, competitive hospital contracting, low-loss transfer systems, and documented emissions-management capabilities.

References

1. U.S. Food and Drug Administration. (2023). SUPRANE (desflurane, USP) liquid for inhalation prescribing information. Baxter Healthcare Corporation.

2. United States Code. (2024). 35 U.S.C. § 154: Contents and term of patent; provisional rights.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.

4. U.S. Food and Drug Administration. (2020). Abbreviated new drug application submissions: Content and format guidance for industry.

5. Sulbaek Andersen, M. P., Nielsen, O. J., Wallington, T. J., Karpichev, B., & Sander, S. P. (2012). Medical intelligence article: Assessing the impact on global climate from general anesthetic gases. Anesthesia & Analgesia, 114(5), 1081-1085.