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Last Updated: December 31, 2025

ISOFLURANE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Isoflurane

A generic version of ISOFLURANE was approved as isoflurane by PIRAMAL CRITICAL on September 30th, 1994.

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Drug patent expirations by year for ISOFLURANE
Recent Clinical Trials for ISOFLURANE

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SponsorPhase
Liaquat National Hospital & Medical CollegePHASE1
Xijing HospitalPHASE3
Ain Shams UniversityPHASE3

See all ISOFLURANE clinical trials

Pharmacology for ISOFLURANE
Drug ClassGeneral Anesthetic
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for ISOFLURANE
Anatomical Therapeutic Chemical (ATC) Classes for ISOFLURANE

US Patents and Regulatory Information for ISOFLURANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halocarbon Prods ISOFLURANE isoflurane LIQUID;INHALATION 075225-001 Oct 20, 1999 AN RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Piramal Pharma ISOFLURANE isoflurane LIQUID;INHALATION 074502-001 Jun 27, 1995 AN RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira ISOFLURANE isoflurane LIQUID;INHALATION 074097-001 Jan 25, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Piramal Critical ISOFLURANE isoflurane LIQUID;INHALATION 074416-001 Sep 30, 1994 AN RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs Inc ISOFLURANE isoflurane LIQUID;INHALATION 074393-001 May 12, 1995 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shandong ISOFLURANE isoflurane LIQUID;INHALATION 216527-001 Nov 4, 2025 AN RX 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 Isoflurane: An In-Depth Analysis

Last updated: December 26, 2025

Summary

Isoflurane, a cornerstone inhalational anesthetic introduced in the 1980s, remains a pivotal agent in modern surgical practices. Despite being a mature market segment, the drug's market landscape is evolving driven by globalization, regulatory policies, technological advances, and emerging alternatives. This report analyzes the current market dynamics, regulatory trends, financial projections, and future growth prospects of Isoflurane. It highlights key industry challenges, competitive landscape shifts, and potential opportunities for stakeholders.

Introduction

Isoflurane (chemical formula: C_15H_19F_3O) is a volatile, inhaled anesthetic primarily used to induce and maintain surgical anesthesia. Marketed under brand names such as Forane, Isoflurane is produced by major pharmaceutical firms, like Abbott Laboratories and Hikma Pharmaceuticals, among others. Its use is heavily dictated by global healthcare policies, cost considerations, and technological developments.

Current Market Size and Revenue Overview

Parameter Data/Estimate Source/Notes
Global market value (2022) US$ 650 million Based on market reports (Grand View Research, 2022)
Annual growth rate (CAGR 2023-2028) 3.2% Estimated from historical data and industry forecasts
Major markets US, Europe, Asia-Pacific Dominant regions based on surgical procedures and anesthesia usage
Number of annual procedures using inhalational anesthesia 150 million WHO estimates (2021)

Market Dynamics

What are the key drivers influencing Isoflurane's market?

Drivers Details Implications
Established Safety Profile Recognized for its cardiovascular stability and minimal hepatic metabolism Sustains demand in high-risk surgeries
Global Surgical Volume Rising number of surgeries worldwide, particularly in aging populations Expands market base
Technological Advances in Anesthesia Delivery Innovations like vaporizers and anesthesia management systems Facilitates safer, more efficient use
Regulatory Approvals and Policies Variations in approvals and regulations influence manufacturing and distribution Markets with favorable policies have growth potential

What are the major constraints?

Constraints Details Impact
Environmental Concerns High global warming potential (GWP) of inhalational anesthetics, including Isoflurane Regulatory pressures for greener alternatives
Emerging Alternatives Intravenous agents like propofol gaining popularity Potential substitution reducing Isoflurane demand
Cost and Supply Chain Fluctuations in raw material costs and manufacturing complexities Profit margin pressures

Regulatory Landscape

Region Key Regulations Impact Current Status
United States FDA approvals, DEA scheduling Stringent regulations for manufacturing and handling Approved; ongoing compliance
European Union EMA directives Focus on environmental impact, Green health policy Approved, eco-focused adaptations
Asia-Pacific Varying standards; increasing adoption Growing markets, less rigorous regulation Expanding markets, some regulatory challenges

Competitive Landscape

Key Players Market Share (2022) Notable Strategies Product Portfolio Highlights
Abbott Laboratories ~45% Diversification, manufacturing capacity expansion Forane (Isoflurane)
Hikma Pharmaceuticals ~25% Market expansion in emerging economies Isoflurane formulations
Other Regional Players ~30% Focus on cost competitiveness Various generic and branded options

Financial Trajectory and Market Forecast

Revenue Projections (2023-2028)

Year Estimated Market Value (USD Million) Growth % Notes
2023 670 Base year
2024 691 3.1% Growth driven by surgery volume
2025 713 3.2% Technological upgrades and emerging markets
2026 736 3.2% Regulation-driven increases in specific regions
2027 759 3.2% Market stabilization
2028 783 3.2% Slight acceleration possible due to emerging markets

Cost Structure and Profitability

Factor Approximate Cost Share Notes
Raw materials 15-20% Fluorinated compounds, stabilizers
Manufacturing 20-25% Energy-intensive with strict quality standards
Regulatory compliance 10-15% Quality control, environmental compliance
Distribution & Marketing 10% Regional variations

Profit Margins

Parameter Estimated Range Notes
Gross profit margin 30-40% Industry average
Net profit margin 10-15% Amidst moderating demand and regulatory costs

Future Opportunities

Green Anesthesia: The Environmental Push

Initiatives Details Opportunities
GWP Reduction Advocacy for low-GWP anesthetics Development of alternatives like Sevoflurane or total intravenous anesthesia
Regulatory Changes European Green Deal policies Incentives for eco-friendly production

Technological Innovation in Delivery Devices

Innovations Potential Impact Stakeholder Benefits
Smart vaporizers Enhanced precision, safety Market differentiation
Automation systems Reduced human error Increased clinical adoption

Market Expansion in Emerging Economies

Countries Opportunities Challenges
India, China Large surgical volumes, expanding healthcare infrastructure Regulatory variability, supply chain logistics

Comparison with Alternative Anesthetics

Agent Advantages Disadvantages Market Positioning
Sevoflurane Faster induction, lower pungency Higher GWP than Isoflurane Growing competitor
Desflurane Rapid emergence Very high GWP, costs Niche applications
Total Intravenous Anesthesia (TIVA) No GWP, rapid recovery Requires infusion pumps, monitoring Alternative, niche market

Challenges and Risks

Risk Factor Impact Mitigation Strategies
Environmental Regulations Increased compliance costs Invest in greener formulations
Emerging Alternatives Market share erosion R&D for innovation
Supply Chain Disruptions Product shortages Diversify suppliers, local manufacturing

Key Takeaways

  • The Isoflurane market is projected to grow modestly (~3.2% CAGR) through 2028, driven by global surgical volume increases.
  • Environmental concerns regarding GWP are fostering regulatory scrutiny, prompting a shift toward greener practices and alternative anesthetics.
  • Major players continue to dominate, though regional companies are expanding, with emerging markets offering significant growth potential.
  • Technological advancements in delivery devices and anesthesia management systems may enhance safety and operational efficiency, supporting market stability.
  • Stakeholders must navigate regulatory landscapes, environmental policies, and competitive pressures by investing in innovation and sustainable practices.

FAQs

1. What are the primary factors influencing Isoflurane's global demand?

Global demand is primarily driven by increasing surgical procedures, the safety profile of Isoflurane, technological innovations, and healthcare expenditure growth, especially in emerging markets.

2. How do environmental regulations impact the Isoflurane market?

Regulations targeting the GWP of inhalational anesthetics are compelling manufacturers to develop low-GWP alternatives or shift toward total intravenous anesthesia, which could restrict Isoflurane's growth.

3. Are there significant regional differences in Isoflurane regulation and usage?

Yes. The US and Europe enforce strict environmental and safety regulations, while Asia-Pacific markets exhibit less regulation but are rapidly expanding due to increasing surgical volumes.

4. What technological innovations could influence Isoflurane’s market share?

Smart vaporizers, automated anesthesia delivery systems, and integrated monitoring platforms improve safety and efficiency, potentially solidifying Isoflurane's position when combined with sustainable practices.

5. What are the key opportunities for investment within the Isoflurane segment?

Investors should focus on companies innovating in greener anesthetic formulations, technologically advanced delivery systems, and expanding into emerging markets with increasing healthcare access.


References

[1] Grand View Research, "Inhalational Anesthetics Market Size, Share & Trends Analysis Report," 2022.
[2] World Health Organization (WHO), "Surgical Procedures Data," 2021.
[3] European Medicines Agency (EMA), "Environmental Impact Policies," 2022.
[4] MarketWatch, "Inhalational Anesthetic Drugs Industry Trends," 2023.
[5] Statista, "Global Healthcare Market Overview," 2022.

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