Sevoflurane - Generic Drug Details

What are the generic sources for sevoflurane and what is the scope of freedom to operate?

Sevoflurane is the generic ingredient in three branded drugs marketed by Baxter Hlthcare, Halocarbon Prods, Shandong, Shanghai Hengrui, Piramal Critical, and Abbvie, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for sevoflurane. Eleven suppliers are listed for this compound.

Summary for sevoflurane

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	991
Patent Applications:	6,543
Drug Prices:	Drug price trends for sevoflurane
What excipients (inactive ingredients) are in sevoflurane?	sevoflurane excipients list
DailyMed Link:	sevoflurane at DailyMed

See drug prices for sevoflurane

Recent Clinical Trials for sevoflurane

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

Sponsor	Phase
Liaquat National Hospital & Medical College	PHASE1
Xijing Hospital	PHASE3
Ataturk University	NA

See all sevoflurane clinical trials

Pharmacology for sevoflurane

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for sevoflurane

N01AB	Halogenated hydrocarbons
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for sevoflurane

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	AN	RX	Yes	Yes
Halocarbon Prods	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	078650-001	Nov 19, 2007	AN	RX	No	No
Shandong	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	214382-001	Aug 18, 2023	AN	RX	No	No
Baxter Hlthcare	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	075895-001	Jul 2, 2002	AN	RX	No	No

Expired US Patents for sevoflurane

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995

EU/EMA Drug Approvals for sevoflurane

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chanelle Pharmaceuticals Manufacturing Limited	Sevohale (previously known as Sevocalm)	sevoflurane	EMEA/V/C/004199For the induction and maintenance of anaesthesia.	Authorised	yes	no	no	2016-06-21
Zoetis Belgium SA	SevoFlo	sevoflurane	EMEA/V/C/000072For the induction and maintenance of anaesthesia in dogs and cats.	Authorised	no	no	no	2002-12-11

Market Dynamics and Financial Trajectory for Sevoflurane

Last updated: July 27, 2025

Introduction

Sevoflurane, a volatile liquid anesthetic agent, plays a crucial role in modern anesthesia practices worldwide. It is favored for its rapid onset, low blood solubility, and minimal renal and cardiovascular side effects. As a cornerstone in inhalational anesthesia, sevoflurane’s market dynamics are influenced by evolving clinical preferences, technological advancements, regulatory landscapes, and competitive pressures. This analysis explores the current market environment, growth drivers, challenges, and financial outlook of sevoflurane over the next decade to assist stakeholders in strategic decision-making.

Market Overview

Global Market Size and Growth Trends

The global inhalational anesthetics market was valued at approximately USD 1.1 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 4.2% from 2023 to 2030 [1]. Sevoflurane comprises a substantial portion of this market, owing to its widespread clinical adoption. Its dominance is supported by a preference for inhalational agents over intravenous anesthetics in certain surgical settings, driven by safety profiles and ease of titration.

Regional Market Distribution

North America dominates the sevoflurane market, accounting for over 40% of total revenue, underpinned by advanced healthcare infrastructure, high surgical volume, and robust adoption of modern anesthetic agents. Europe follows, buoyed by aging populations and increasing surgical procedures. The Asia-Pacific region exhibits significant growth potential, projected to grow at a CAGR exceeding 5%, owing to expanding healthcare access, increasing GDP, and rising awareness of anesthetic options [2].

Market Drivers

Advancements in Anesthesia Technology

Innovations in anesthetic delivery systems, such as precision vaporizers and closed-circuit anesthesia, bolster sevoflurane’s clinical utility. Its compatibility with modern anesthesia machines amplifies its attractiveness in both operating rooms and emerging healthcare markets.

Safety and Favorability Profile

Sevoflurane’s rapid induction and emergence facilitate efficient operating room turnover, increasing procedural throughput. Its minimal airway irritation and low solubility significantly reduce postoperative nausea and vomiting, factors contributing to its preference among anesthesiologists.

Growing Surgical Volume

The global increase in surgical procedures, particularly in orthopedic, cardiovascular, and neurological surgeries, sustains demand for inhalational anesthetics. Aging populations escalate the need for diverse surgical interventions, directly influencing sevoflurane consumption.

Regulatory Approvals & Patent Expirations

While originally patented in the 1990s, sevoflurane’s primary patents have expired, encouraging generic manufacturing. The cost competitiveness in generics enhances market accessibility, especially in price-sensitive regions.

Market Challenges

Environmental Concerns

Sevoflurane, like other volatile anesthetics, is a potent greenhouse gas. Its global warming potential (GWP) approximately 2,100 times that of CO₂ has prompted environmental scrutiny and calls for sustainable alternatives. This pressure may impact future regulatory policies and industry practices.

Competition from Alternative Agents

Total intravenous anesthesia (TIVA) agents such as propofol pose competition due to their ease of administration and reduced environmental impact. Moreover, newer inhalational agents like desflurane and isoflurane are also vying for market share based on specific clinical advantages.

Regulatory and Safety Regulations

Stringent regulatory oversight related to supply quality, environmental impact, and training standards can influence market dynamics. Variations across regions can create complexities in compliance and distribution.

Financial Trajectory & Market Opportunities

Forecasted Revenue Growth

Based on current trends, the sevoflurane segment is expected to grow at a CAGR of 4-5% through 2030 [3]. Revenue opportunities are especially prominent in the emerging markets of Asia-Pacific and Latin America, where infrastructural development and healthcare investments are accelerating.

Price Trends and Market Margins

The entry of generics has driven down prices, widening access but pressuring profit margins for branded producers. Manufacturers who leverage cost efficiencies, invest in sustainable practices, and expand into underserved regions can capitalize on profit growth.

Strategic Supply Chain and Manufacturing

Regional manufacturing hubs, particularly in India and China, have become integral to ensuring supply resilience and cost-effective production. Strategic partnerships and investments in environmental mitigation technologies will be critical to sustaining financial benefits.

Innovation and Diversification

Investment in research for low-GWP inhalational anesthetics or alternative delivery platforms presents future growth avenues. Companies that innovate beyond traditional formulations could capture niche markets and mitigate environmental regulations.

Regulatory Landscape and Future Outlook

Sustainability Initiatives

International agreements, such as the Montreal Protocol and Climate Change policies, influence anesthetic practice reforms. Industry players are exploring options like gas abatement systems or developing alternative agents with a lower GWP profile.

Market Entry and Competition Policies

Patent expirations catalyze competition but also prompt innovation. Regulatory agencies focus increasingly on environmental assessments, impacting the approval process and market entry strategies for new formulations.

Conclusion

Sevoflurane’s market remains robust, buoyed by clinical efficacy and safety profile. However, environmental considerations, competitive innovations, and regional healthcare development will shape its trajectory. Stakeholders poised to adapt through sustainable practices, technological innovation, and strategic regional expansion stand to capitalize on anticipated growth.

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Key Takeaways

• Market Growth: The global sevoflurane market is projected to grow at approximately 4-5% CAGR through 2030, driven by expanding surgical procedures and technological advancements.

• Regional Opportunities: Asia-Pacific and emerging markets present significant upside due to rising healthcare investments and infrastructure development.

• Competitive Edge: Companies should focus on cost efficiencies, sustainable manufacturing practices, and innovation in low-GWP anesthetics to sustain and grow market share.

• Environmental Impact: Legislative and industry shifts towards sustainability will necessitate innovation in anesthetic delivery and broader environmental mitigation strategies.

• Regulatory Adaptation: Navigating diverse regional regulations and promoting compliance will be crucial, especially concerning environmental standards and product approvals.

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FAQs

1. What factors influence the global demand for sevoflurane?
   Clinical safety profile, rapid onset and emergence, technological compatibility, expanding surgical procedures, and regional healthcare development primarily drive demand.

2. How do environmental concerns impact the sevoflurane market?
   Its high GWP prompts regulatory scrutiny, leading to potential restrictions, increased adoption of environmentally friendly alternatives, and development of mitigation technologies.

3. What role do generics play in sevoflurane’s market growth?
   Patent expirations have facilitated generic entry, reducing prices, enhancing access, and increasing overall market volume, although impacting branded profit margins.

4. Are there ongoing innovations aimed at reducing sevoflurane’s environmental footprint?
   Yes, companies are researching low-GWP agents, gas reclamation systems, and alternative delivery methods to address environmental concerns.

5. Which regions are expected to exhibit the highest growth for sevoflurane?
   The Asia-Pacific region is projected to lead due to increasing healthcare infrastructure, rising surgical volume, and favorable economic growth.

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References

[1] MarketsandMarkets, "Inhalational Anesthetics Market," 2022.

[2] Research and Markets, “Global Anesthesia Market Analysis,” 2023.

[3] Grand View Research, "Anesthetics Market Size & Trends," 2022.