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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	1,002
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
University of South Alabama	PHASE4
Liaquat National Hospital & Medical College	PHASE1
dilara gocmen	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
Baxter Hlthcare	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	075895-001	Jul 2, 2002	AN	RX	No	No
Shanghai Hengrui	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	203793-001	Nov 3, 2015	AN	RX	No	No
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	AN	RX	Yes	Yes
Piramal Critical	SOJOURN	sevoflurane	LIQUID;INHALATION	077867-001	May 2, 2007	AN	RX	No	No
Halocarbon Prods	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	078650-001	Nov 19, 2007	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 Overview and Financial Outlook for Sevoflurane

Last updated: February 12, 2026

Sevoflurane, an inhaled anesthetic, has been a standard agent in general anesthesia since its approval in the late 1990s. Its market presence is driven by its rapid onset, low airway irritation, and minimal metabolic breakdown. The drug's commercial landscape is characterized by a consolidation of manufacturing rights among key pharmaceutical companies and steady regional demand growth, especially in emerging markets.

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Market Size and Revenue Trends

The global inhaled anesthetics market was valued at approximately $1.2 billion in 2021. Sevoflurane accounts for an estimated 35-45% market share within this segment, translating to revenues around $420–$540 million in 2022.

Projected growth rates suggest a compound annual growth rate (CAGR) of 3-5% through 2028. This growth is influenced by overall increases in surgical procedures, healthcare infrastructure expansion, and rising anesthesia use in outpatient surgeries.

Regional Market Distribution

Region	Market Share (2022)	Growth Drivers
North America	40%	High procedural volume, established healthcare infrastructure
Europe	25%	Aging populations, adoption of modern anesthetics
Asia-Pacific	20-25%	Expanding healthcare access, increasing surgical procedures
Latin America & Others	10-15%	Growing healthcare investment in emerging economies

Emerging markets exhibit higher growth potential due to lower current market penetration and increased hospital construction.

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Competitive Landscape

Major manufacturers holding marketing and production rights include:

• AbbVie (under license from Baxter for 50% of global rights): Strong presence in North America.
• Maruishi Pharmaceutical (Japan): Dominant in Asia.
• Pfizer (historically): Sold rights in some regions; exited certain markets post-merger with Hospira.
• Nippon Shinyaku (Japan): Supplies for local markets.

The consolidation of patents and licensing agreements influences supply stability and pricing strategies.

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Pricing Trends and Margin Considerations

Average wholesale price (AWP) for sevoflurane ranges from $12 to $20 per vial, with regional variations. Manufacturing costs are estimated at $5–$7 per vial, leading to potential profit margins between 50%-60%, contingent on volume and regional pricing pressures.

Price reductions have occurred due to increased generic competition, especially post-patent expiry of key formulations around 2010-2012. Contract manufacturing and patent litigations influence supply and pricing stability.

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Regulatory and Reimbursement Factors

• Regulatory Approvals: Sevoflurane is approved by FDA, EMA, and other major authorities, with market access impacted by regional pharma policies.

• Reimbursement Policies: Reimbursement rates vary across regions, with high-income countries offering coverage aligned with procedure volume. Reimbursement influences demand and market penetration.

Supply Chain Considerations

Manufacturing relies heavily on volatile raw materials such as sulfur hexafluoride and volatile organic compounds. Any disruption in supply chains or regulatory compliance penalties could affect availability and pricing.

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Market Risks and Opportunities

Risks:

• Increase in generic competition drives price erosion.
• Regulatory changes impacting manufacturing standards.
• Shift towards alternative anesthetic agents like desflurane and newer intravenous options.

Opportunities:

• Growth in outpatient and ambulatory surgical centers expands utilization.
• Adoption in emerging markets driven by increasing healthcare investment.
• Development of new formulations that enhance safety or ease of use.

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Financial Trajectory Outlook

Revenue growth for sevoflurane is expected to align with the broader anesthetic market CAGR of 3-5%. Revenue streams should stabilize as patent protections expire and generic supply broadens, pressuring margins.

Investment in regional expansion and manufacturing efficiency can mitigate margin erosion. Strategic licensing and partnerships may sustain revenues, especially in high-growth emerging markets.

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Key Takeaways

• The global sevoflurane market was approximately $420–$540 million in 2022, with stable growth expectations.
• North America and Europe dominate, but Asia-Pacific shows high growth potential due to expanding healthcare infrastructure.
• Competitive landscape includes a mix of regional and multinational players, with patent expirations prompting increased generic competition.
• Pricing remains subject to regional reimbursement policies, with margins impacted by manufacturing costs and competition.
• Supply chain resilience and regulatory compliance are critical risk factors.
• Opportunities exist in outpatient markets, emerging economies, and through innovation in formulations.

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FAQs

1. What factors influence the pricing of sevoflurane?
Pricing is influenced by manufacturing costs, regional reimbursement policies, patent status, and competition from generics.

2. How does patent expiration impact sevoflurane's market?
Patent expiration around 2010-2012 led to increased generic competition, driving prices down and reducing revenue margins for brand-name producers.

3. What regions are projected to see the highest growth in sevoflurane demand?
Asia-Pacific and Latin America exhibit the highest growth potential due to expanding healthcare infrastructure and surgical procedures.

4. How do supply chain risks affect the supply of sevoflurane?
Dependence on volatile raw materials and manufacturing disruptions can lead to shortages, affecting pricing and availability.

5. Will new inhaled anesthetics significantly impact sevoflurane's market share?
Potentially, if newer agents offer safety, cost, or ease-of-use improvements. However, sevoflurane maintains a strong clinical position due to its proven efficacy.

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Citations

[1] MarketsandMarkets. "Inhaled Anesthetics Market," 2022 Data.
[2] Fortune Business Insights. "Global Anesthetics Market Size, Share & Industry Analysis," 2022.
[3] Decision Resources Group. "Regional Market Dynamics for Inhaled Anesthetics," 2021.