Last Updated: September 24, 2026

DESFLURANE - Generic Drug Details


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What are the generic sources for desflurane and what is the scope of patent protection?

Desflurane is the generic ingredient in two branded drugs marketed by Shanghai Hengrui and Baxter Hlthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for DESFLURANE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 287
Patent Applications: 3,838
What excipients (inactive ingredients) are in DESFLURANE?DESFLURANE excipients list
DailyMed Link:DESFLURANE at DailyMed
Recent Clinical Trials for DESFLURANE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Konya City HospitalNA
Xijing HospitalPHASE3
Ataturk UniversityNA

See all DESFLURANE clinical trials

Pharmacology for DESFLURANE
Drug ClassGeneral Anesthetic
Physiological EffectGeneral Anesthesia
Anatomical Therapeutic Chemical (ATC) Classes for DESFLURANE
Paragraph IV (Patent) Challenges for DESFLURANE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUPRANE Inhalation desflurane 99.9% 020118 1 2008-09-11

US Patents and Regulatory Information for DESFLURANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare SUPRANE desflurane LIQUID;INHALATION 020118-001 Sep 18, 1992 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Shanghai Hengrui DESFLURANE desflurane LIQUID;INHALATION 208234-001 Feb 26, 2018 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

Desflurane Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 1, 2026

Desflurane is a mature, off-patent inhaled anesthetic with declining commercial prospects. Its market is contracting because hospitals are substituting sevoflurane, isoflurane, propofol-based total intravenous anesthesia, and regional anesthesia. The main driver is desflurane's exceptionally high greenhouse-gas impact rather than patent competition. Standalone global revenue is not publicly reported by the principal manufacturers, but the product's financial trajectory is consistent with a low-growth or declining generic market.

What is the current market position of desflurane?

Desflurane is a volatile halogenated anesthetic used for induction and maintenance of general anesthesia. In the United States, the reference product is Suprane, originally developed and commercialized by Baxter. Generic and hospital-supply versions are also available in selected markets.

Desflurane has several clinical advantages:

  • Rapid onset and emergence because of its low blood-gas solubility.
  • Predictable titration through an anesthetic vaporizer.
  • Limited hepatic metabolism compared with older inhaled anesthetics.
  • Use in lengthy procedures where rapid recovery is clinically valuable.

Its disadvantages have become commercially more important:

  • High acquisition cost relative to some alternatives.
  • Requirement for a specialized heated vaporizer.
  • Airway irritation and a relatively high incidence of coughing or laryngospasm during induction.
  • High climate impact from operating-room emissions.
  • Availability of lower-emission substitutes with similar clinical utility.

Desflurane's commercial status is therefore that of a mature hospital product rather than a growth pharmaceutical. Demand is concentrated in operating rooms, ambulatory surgery centers, and hospital formularies. It has limited differentiation that can support premium pricing.

How large is the desflurane market?

Public companies generally do not disclose desflurane sales as a separate revenue category. Baxter reports broader pharmaceutical and medical-product results rather than a standalone Suprane revenue line. Generic suppliers also do not normally publish product-level sales.

The market is best analyzed through utilization and substitution rather than headline revenue:

Market factor Desflurane position Financial effect
Product lifecycle Mature and off patent Limits pricing power
Main customers Hospitals and ambulatory surgery centers Concentrated procurement
Key alternatives Sevoflurane, isoflurane, propofol, regional anesthesia Sustained substitution pressure
Environmental profile Very high global-warming potential Accelerates formulary restrictions
Manufacturing Established, but specialized production and packaging Supports supply barriers but not strong pricing
Reimbursement Usually embedded in procedure economics Weak direct manufacturer pricing leverage
Revenue disclosure No consistent standalone reporting Prevents reliable public market-size calculation

Demand has declined most rapidly in health systems with formal anesthetic-gas reduction targets. The United Kingdom has been among the most aggressive markets. NHS guidance directed providers to phase out desflurane except where clinically justified, with the policy objective taking effect from 2024 [1].

The United States has moved more gradually. Hospitals and health systems have adopted environmental purchasing policies, but national utilization remains dependent on local anesthesia protocols, supply contracts, and clinician preference.

Why is desflurane losing market share?

Environmental regulation and hospital procurement

Desflurane has a global-warming potential of approximately 2,540 over a 100-year period, compared with approximately 130 for sevoflurane and 510 for isoflurane. Its atmospheric lifetime is also substantially longer than that of many competing anesthetic gases [2].

This difference changes procurement decisions. Hospitals increasingly evaluate volatile anesthetics through:

  • Carbon-accounting programs.
  • Sustainability-linked purchasing policies.
  • National health-system targets.
  • Operating-room waste reduction programs.
  • Supplier reporting requirements.

Desflurane's environmental disadvantage is difficult to offset through recycling because the anesthetic is released during administration and exhalation. Scavenging systems reduce occupational exposure but do not eliminate the climate impact of the product.

Clinical substitution

Sevoflurane is the most direct substitute in many operating rooms. It is less irritating to the airway and is suitable for inhalational induction, particularly in pediatric anesthesia. Its climate impact is materially lower, although its product price and consumption depend on dosing, fresh-gas flow, and local procurement.

Propofol-based total intravenous anesthesia removes volatile anesthetic emissions but requires infusion pumps, intravenous access, and different recovery protocols. Regional anesthesia and neuraxial techniques can also reduce use of general anesthetics in selected procedures.

Desflurane retains a role where rapid emergence is valued, but this advantage is rarely sufficient to overcome environmental restrictions or procurement pressure.

What is the FDA and Orange Book status of desflurane?

The FDA approved Suprane under NDA 020118. Desflurane is an approved inhalational general anesthetic, not a biologic, and it is not eligible for biosimilar competition [3].

Its regulatory profile is mature:

Regulatory issue Status
FDA product Suprane, desflurane
NDA 020118
Dosage form Volatile liquid for vaporization
Administration Inhalation through an anesthesia vaporizer
Regulatory category Small-molecule drug
Reference-product exclusivity Expired
Biosimilar pathway Not applicable
Generic pathway ANDA, subject to FDA requirements
Orange Book relevance Reference-product and patent-certification framework applies where listed

The principal commercial threat is generic and therapeutic substitution, not loss of regulatory exclusivity. FDA approval of competing products does not require the market to retain desflurane utilization if hospitals remove it from formularies.

What patents protect desflurane?

Desflurane's original pharmaceutical composition and core anesthetic use are long past the period of meaningful patent protection. The compound was introduced commercially in the 1990s, and the reference product has no remaining practical market exclusivity based on its original composition patent.

Potentially relevant intellectual-property categories include:

  1. The desflurane compound and its pharmaceutical use.
  2. Manufacturing and purification processes.
  3. Packaging and storage systems.
  4. Vaporizer technology.
  5. Anesthesia delivery systems.
  6. Formulation and container specifications.

The strongest residual barriers are likely to be manufacturing know-how, quality-control systems, regulatory files, and supply-chain qualification rather than enforceable product patents. Vaporizer patents may protect equipment sold by anesthesia-device manufacturers, but those rights do not create exclusive pharmaceutical control over desflurane.

No active patent estate comparable to the estates surrounding branded oncology, immunology, or metabolic products drives desflurane's commercial value. Patent expiry has shifted competition toward manufacturing cost, supply reliability, contracting, and environmental policy.

When did desflurane lose exclusivity?

Desflurane lost meaningful brand exclusivity years ago. The reference product's commercial position is no longer protected by a new chemical entity period, pediatric exclusivity, or active patent thicket.

The key lifecycle milestones are:

Milestone Approximate timing
Original clinical development and approval period Early 1990s
U.S. commercial launch of Suprane 1990s
Core patent and regulatory exclusivity period Expired
Generic competition Established in multiple markets
Environmental-driven substitution Accelerated during the late 2010s and 2020s
Current lifecycle phase Mature, declining hospital product

The precise commercial entry date varies by jurisdiction and supplier. The strategic conclusion is consistent across major markets: patent expiry is historical, and the remaining value lies in manufacturing and distribution rather than exclusivity.

Are generic manufacturers challenging desflurane?

Desflurane is already a genericized product. The relevant competition is not a new wave of Paragraph IV litigation but continuing competition among approved suppliers and therapeutic alternatives.

Paragraph IV risk

Paragraph IV certifications are most relevant when an ANDA applicant seeks approval before listed patents expire. Because desflurane's core exclusivity period has ended, a new large-scale Paragraph IV campaign would have limited commercial significance unless a supplier asserted a later manufacturing, formulation, or delivery patent.

The more material competitive risks are:

  • Price competition among approved suppliers.
  • Supply interruptions.
  • Hospital conversion to sevoflurane or propofol.
  • National restrictions on high-emission anesthetics.
  • Loss of formulary status.
  • Lower utilization per procedure through low-flow anesthesia.

Generic supply structure

Desflurane production requires specialized fluorinated chemical manufacturing, pharmaceutical purification, stability control, and packaging. These requirements create a higher operational barrier than ordinary solid-dose generics. They do not, however, provide durable market exclusivity when several qualified suppliers can manufacture or source the active ingredient.

Which companies compete in the desflurane market?

Baxter is the most visible reference-product company through Suprane. Generic hospital-supply companies and regional pharmaceutical manufacturers compete in markets where desflurane remains listed.

The broader competitive field includes:

Competitor Competitive role
Sevoflurane manufacturers Primary inhaled-anesthetic substitute
Isoflurane manufacturers Lower-cost volatile anesthetic substitute
Propofol manufacturers Intravenous alternative
Regional-anesthesia suppliers Procedure-level substitute
Anesthesia-device manufacturers Control vaporizer and delivery economics
Hospital pharmacy distributors Influence purchasing and availability

The most important competitor is sevoflurane because it preserves the inhaled-anesthesia workflow while addressing some of desflurane's clinical and environmental disadvantages.

How does desflurane compare with sevoflurane?

Attribute Desflurane Sevoflurane
Blood-gas solubility Very low Low
Emergence speed Very rapid Rapid
Airway irritation Higher Lower
Pediatric inhalational induction Less suitable More suitable
Vaporizer requirement Heated, specialized Standard variable-bypass vaporizer
Global-warming potential Approximately 2,540 Approximately 130
Hospital sustainability position Increasingly restricted More acceptable, though not emission-free
Market outlook Declining More resilient

Desflurane can retain value in selected high-throughput procedures, but sevoflurane has a stronger long-term formulary position. The commercial comparison increasingly turns on total environmental and operating-room cost, not only emergence time.

What is the financial trajectory for desflurane?

Desflurane revenue is likely to decline through a combination of lower volume and limited pricing power.

Revenue drivers

Positive or stabilizing factors include:

  • Continued use in hospitals without strict anesthetic-gas restrictions.
  • Demand for rapid emergence in selected surgical procedures.
  • High switching costs for established vaporizer workflows.
  • Supply scarcity if manufacturers exit the market.
  • Long-term contracts with hospitals and distributors.

Negative factors are stronger:

  • Formulary removal.
  • Substitution by sevoflurane.
  • Use of propofol-based anesthesia.
  • Environmental procurement standards.
  • Generic price competition.
  • Declining use of high fresh-gas-flow techniques.
  • Potential manufacturer portfolio rationalization.

The likely financial pattern is:

  1. Volume decline.
  2. Stable or modestly higher nominal prices in constrained markets.
  3. Lower total revenue because price increases do not offset utilization losses.
  4. Higher per-unit manufacturing costs if production volumes fall.
  5. Potential supply concentration after supplier exits.
  6. Further demand erosion as remaining hospitals adopt sustainability targets.

This is a classic mature-product decline, but environmental policy makes the decline faster than patent expiry alone would have produced.

What licensing deals and commercial partnerships affect desflurane?

Desflurane has not generated the type of licensing activity associated with innovative drugs, platform technologies, or specialty delivery systems. Commercial relationships generally involve:

  • Product distribution.
  • Hospital procurement contracts.
  • Contract manufacturing.
  • Regional marketing rights.
  • Anesthesia-equipment compatibility.
  • Pharmaceutical wholesaling.

The absence of major late-stage licensing activity reflects the product's generic status and limited growth prospects. Any value in a transaction would likely come from supply reliability, geographic access, manufacturing capacity, or a broader anesthesia portfolio rather than desflurane alone.

What patent litigation and settlement risks affect desflurane?

Patent litigation is not the primary risk category. The original compound is mature, and no prominent current settlement structure is central to the market's outlook.

The more important legal and regulatory exposures are:

  • Product-quality investigations.
  • Manufacturing compliance.
  • Drug shortages and allocation decisions.
  • Environmental procurement rules.
  • Contract disputes involving hospital supply.
  • Labeling and safety obligations.
  • Competition-law issues if supply becomes concentrated.

A generic manufacturer seeking entry would face ordinary FDA quality and bioequivalence requirements, but the central challenge would be commercial demand. Regulatory approval alone would not guarantee a viable market if hospitals are actively eliminating desflurane.

What generic launch scenarios exist for desflurane?

Three scenarios are commercially plausible.

Base case: gradual contraction

Desflurane remains available in the United States and selected international markets. Utilization declines as hospitals convert patients to sevoflurane or intravenous anesthesia. Suppliers continue serving a shrinking installed base.

Downside case: accelerated withdrawal

Large health systems adopt blanket restrictions, and one or more suppliers discontinue the product. Supply becomes less reliable, prices rise temporarily, and hospitals complete conversion to alternatives.

Limited-support case: niche persistence

Desflurane remains in selected operating rooms because clinicians value rapid emergence or because alternatives are operationally less efficient. Revenue stabilizes at a smaller base, with supply concentrated among fewer manufacturers.

A new generic launch would have the strongest rationale in markets where desflurane remains reimbursed, hospital demand is stable, and incumbent supply is constrained. It would have weak economics in jurisdictions with formal phaseout policies.

What geographic markets remain relevant?

The United Kingdom and parts of Western Europe have experienced the strongest environmental pressure. Some hospitals and national systems have restricted or eliminated desflurane use.

North America remains more heterogeneous. U.S. utilization depends on individual health-system policies, state-level sustainability programs, anesthesia department protocols, and supplier contracts.

Emerging markets may retain demand longer because:

  • Environmental procurement rules are less developed.
  • Existing anesthesia equipment remains in place.
  • Hospital budgets prioritize acquisition cost and availability.
  • Sevoflurane and propofol supply may be less consistent.
  • Regulatory substitution policies are less coordinated.

The long-term geographic pattern is likely to be a shrinking high-income market and a slower-declining emerging-market segment.

How strong is the desflurane patent and commercial estate?

The patent estate is weak as a source of exclusivity but the manufacturing estate can still have practical value.

Estate component Strength
Original compound patents Low commercial relevance
Method-of-use patents Low, absent a new protected indication
Formulation patents Limited relevance for a volatile anesthetic
Vaporizer technology Potentially relevant to device suppliers
Manufacturing know-how Moderate operational value
Regulatory approvals and quality systems Moderate value
Distribution contracts Short- to medium-term commercial value
Environmental positioning Negative for long-term demand

The product's remaining defensibility is operational, not patent-based. A supplier with qualified manufacturing, reliable inventory, and established hospital contracts can retain share, but it cannot prevent therapeutic substitution.

Key Takeaways

  • Desflurane is an off-patent, mature inhaled anesthetic with a declining market.
  • Baxter's Suprane is the reference product, but standalone sales are not publicly disclosed.
  • Desflurane has a global-warming potential of approximately 2,540, making it materially less attractive than sevoflurane in sustainability-focused health systems.
  • The principal competitive threat is substitution, not Paragraph IV litigation.
  • No biosimilar risk exists because desflurane is a small-molecule drug.
  • Manufacturing know-how, regulatory qualification, and supply reliability matter more than patent protection.
  • The United Kingdom and environmentally focused European markets face the greatest contraction risk.
  • The United States is likely to decline more gradually because policy and formulary decisions remain decentralized.
  • Financial performance should be expected to follow a volume-down, price-limited trajectory.
  • A generic launch is commercially viable only in markets with persistent demand or constrained supply.

FAQs

Is desflurane still approved by the FDA?

Yes. Desflurane remains an FDA-approved inhalational anesthetic, with Suprane associated with NDA 020118 [3].

Is desflurane more expensive than sevoflurane?

Often, yes, depending on acquisition contracts, fresh-gas flow, dosing, and regional pricing. Total cost also includes vaporizer requirements and environmental compliance.

Can hospitals ban desflurane?

Hospitals can remove desflurane from formularies or restrict its use under institutional procurement and sustainability policies. National health systems may impose broader restrictions.

Does desflurane have a pediatric advantage?

Generally no. Sevoflurane is usually preferred for inhalational induction because it is less irritating to the airway.

Will desflurane disappear from the market?

A complete global withdrawal is unlikely in the near term, but availability may become concentrated in fewer suppliers and selected markets. Use is likely to continue declining as hospitals adopt lower-emission anesthetic protocols.

References

  1. NHS England. (2023). NHS clinical waste strategy and anesthetic gas reduction guidance. https://www.england.nhs.uk
  2. U.S. Environmental Protection Agency. (2024). Understanding global warming potentials. https://www.epa.gov/ghgemissions
  3. U.S. Food and Drug Administration. (n.d.). Suprane: Desflurane, NDA 020118. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
  4. Baxter International Inc. (2024). Annual report. https://www.baxter.com
  5. Sulbaek Andersen, M. P., Nielsen, O. J., Karpichev, B., Stenstrøm, Y., & Wallington, T. J. (2012). Atmospheric chemistry of isoflurane, desflurane, and sevoflurane: Kinetics and mechanisms of OH and Cl atom reactions. Atmospheric Chemistry and Physics, 12, 10247-10261. https://doi.org/10.5194/acp-12-10247-2012

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