ETHRANE Drug Patent Profile

Which patents cover Ethrane, and when can generic versions of Ethrane launch?

Ethrane is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in ETHRANE is enflurane. There are three drug master file entries for this compound. Additional details are available on the enflurane profile page.

Summary for ETHRANE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	1
Patent Applications:	3,213
DailyMed Link:	ETHRANE at DailyMed

Recent Clinical Trials for ETHRANE

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

Sponsor	Phase
Nanjing Medical University	N/A

See all ETHRANE clinical trials

US Patents and Regulatory Information for ETHRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ETHRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982

International Patents for ETHRANE

See the table below for patents covering ETHRANE around the world.

Country	Patent Number	Title	Estimated Expiration
Guatemala	197226524	ETER 1,1,2,TRIFLUORO-2-CLOROETIL DIFLUOROMETILICO Y METODO PARA SU PREPARACION.
Germany	1643591
France	1538293	éther de 1, 1, 2-trifluoro-2-chloroéthyle et de difluorométhyle, et procédé pour son obtention
Belgium	764790

Market Dynamics and Financial Trajectory for ETHRANE (Enflurane)

Last updated: July 29, 2025

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Introduction

ETHRANE, a trade name for enflurane, is a halogenated volatile anesthetic agent primarily used during surgical procedures to induce and maintain anesthesia. Since its commercialization, ETHRANE has played a significant role within the perioperative care market. Understanding its market dynamics and financial trajectory involves analyzing regulatory landscapes, competitive positioning, technological advancements, clinical acceptance, and economic factors influencing its adoption and profitability.

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Regulatory Landscape and Market Entry

ETHRANE was introduced in the 1960s and gained widespread acceptance owing to its efficacy and safety profile. However, over recent decades, regulatory agencies such as the FDA and EMA have tightened standards regarding anesthetic agents due to concerns about environmental impact and patient safety. Notably, enflurane’s withdrawal from certain markets, especially in the U.S. during the 2000s, was driven by its association with nephrotoxicity and the availability of newer agents with improved safety profiles [{1}].

In markets where ETHRANE remains approved, continued regulatory vigilance affects manufacturing and distribution. Regulatory divergence across regions creates a complex landscape with potentially limited market access in some territories but sustained demand in others, particularly in countries with established anesthetic protocols that favor older agents.

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Competition and Market Positioning

The anesthetic agent market is highly competitive, dominated by agents such as sevoflurane, desflurane, and isoflurane. These newer agents are favored for their rapid onset and emergence times, minimal metabolism, and improved safety profiles. Consequently, ETHRANE's market share has declined over time, especially in regions prioritizing latest-generation anesthetics.

Despite this, ETHRANE retains niche segments, particularly in hospitals valuing well-established, cost-effective agents or where incompletely transitioned to newer anesthetics. Additionally, its historical clinical familiarity among anesthesiologists maintains a steady demand in legacy systems.

Furthermore, the environmental impact of inhalational anesthetics has become an influential factor. Halogenated agents contribute to greenhouse gas emissions, prompting regulatory and institutional initiatives to reduce their use. ETHRANE’s environmental footprint, possibly similar or marginally less than other agents, may influence future market dynamics.

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Technological and Clinical Evolution

Advances in anesthesia technology, such as the development of total intravenous anesthesia (TIVA) and sophisticated closed-loop delivery systems, have reduced reliance on volatile anesthetics like ETHRANE. Additionally, the focus on rapid recovery profiles and minimized side effects favors agents like sevoflurane and desflurane.

Nevertheless, ETHRANE's advantages include low cost and simplicity of use, which sustain its relevance in resource-constrained settings. Its minimal metabolism reduces certain risks associated with tissue accumulation, although concerns about nephrotoxicity limit its use in some clinical scenarios.

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Economic Factors and Market Trends

The global anesthetic market is projected to grow, driven by increasing surgical procedures due to aging populations, rising prevalence of chronic diseases, and expanding healthcare infrastructure in emerging economies. The anesthetic agents segment is expected to benefit from this growth, although the composition will shift towards newer, safer agents.

ETHRANE's financial trajectory depends heavily on regional adoption and formulary preferences. In mature markets, its revenues are likely to decline gradually due to competition, safety concerns, and environmental considerations. Conversely, in developing markets with constrained healthcare budgets, ETHRANE may sustain moderate revenues due to its cost-effectiveness and familiarity among practitioners.

The cost of production and raw materials for enflurane also influences profitability. As with other halogenated agents, environmental controls and eco-friendly disposal regulations might increase operational costs, impacting margin structures.

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Patent and Commercialization Landscape

ETHRANE itself no longer holds active patents, and generic formulations dominate the market where it is still available. The lack of patent protection limits pricing power, making revenues susceptible to competitive pricing strategies and procurement costs.

Pharmaceutical companies seeking to extend revenue streams use reformulation, combination therapies, or new delivery devices. However, given the age of enflurane, innovation avenues remain limited, affecting its long-term financial prospects.

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Future Outlook and Market Trajectory

While ETHRANE's popularity declines in high-income regions, it persists as a secondary option in specific markets. Its future market trajectory hinges upon:

• Regulatory decisions and environmental policies encouraging or discouraging usage.
• Clinical guidelines preference shifts favoring newer agents with better safety and recovery profiles.
• Economic factors MAKING ETHRANE a cost-containment option, especially in low-resource environments.
• Environmental sustainability initiatives prompting reductions in volatile anesthetic use due to greenhouse gas emissions.

The global anesthetic market, projected to reach USD 1.88 billion by 2027 [{2}], will increasingly favor agents aligned with environmental, safety, and efficiency improvements—potentially further diminishing ETHRANE’s role.

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Key Challenges and Opportunities

• Challenges:
  • Competition from newer inhalational agents with rapid onset and recovery times.
  • Regulatory pressure to phase out volatile anesthetics contributing to greenhouse gases.
  • Safety concerns associated with nephrotoxicity and environmental impact.
• Opportunities:
  • Cost-sensitive markets where ETHRANE remains affordable.
  • Long-standing clinical familiarity that sustains its demand.
  • Potential adaptation in settings emphasizing affordability over rapid pharmacokinetics.

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Key Takeaways

• ETHRANE’s market is contracting in high-income countries due to safety concerns, environmental regulations, and enhanced alternatives.
• The global anesthetic market’s growth is poised to favor newer agents, but ETHRANE retains niche relevance amid cost considerations.
• Regulatory and environmental policies will significantly influence its long-term financial trajectory.
• Companies active in ETHRANE's space should focus on niche markets, cost advantages, and environmental compliance to sustain revenues.
• Innovation in delivery mechanisms or formulations appears unlikely, constraining growth prospects.

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FAQs

1. Why has ETHRANE’s market share decreased globally?
Due to the advent of newer inhalational anesthetics like sevoflurane and desflurane, which offer faster induction and emergence, alongside concerns about nephrotoxicity and environmental impact, ETHRANE’s utilization has diminished.

2. Are there ongoing regulatory restrictions on ETHRANE?
Yes, in certain markets, regulatory agencies have either restricted or phased out ETHRANE owing to safety and environmental concerns. However, it remains approved and used in regions where regulatory frameworks are less restrictive.

3. How does the environmental impact influence ETHRANE’s market future?
As global focus on reducing greenhouse gas emissions intensifies, volatile anesthetics' contribution to environmental harm prompts policies limiting their use, potentially accelerating the decline of ETHRANE.

4. Can ETHRANE’s cost advantage sustain its market?
In low-resource settings, ETHRANE’s affordability and familiarity sustain its demand despite limitations; however, in developed markets, the cost advantage is often offset by safety and environmental considerations.

5. What strategies could prolong ETHRANE’s market presence?
Maintaining niche markets through cost leadership, ensuring regulatory compliance, and tailoring formulations for specific applications can help sustain ETHRANE’s relevance in select regions.

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References

[1] Shafer, S. L., & Goudsouzian, N. K. (2004). Anesthetic pharmacology: Physiologic principles and clinical practice. Elsevier.
[2] Grand View Research. (2021). Anesthetic Drugs Market Size, Share & Trends Analysis Report.