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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	856
Patent Applications:	3,705
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
Keith M. Vogt, MD, PhD	Phase 1
National Institute of General Medical Sciences (NIGMS)	Phase 1
SanQing Jin	N/A

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
Shanghai Hengrui	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	203793-001	Nov 3, 2015	AN	RX	No	No
Piramal Critical	SOJOURN	sevoflurane	LIQUID;INHALATION	077867-001	May 2, 2007	AN	RX	No	No
Baxter Hlthcare	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	075895-001	Jul 2, 2002	AN	RX	No	No
Shandong	SEVOFLURANE	sevoflurane	LIQUID;INHALATION	214382-001	Aug 18, 2023	AN	RX	No	No
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	AN	RX	Yes	Yes

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	5,990,176*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,444,859*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,288,127*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,074,668*PED

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/004199 For the induction and maintenance of anaesthesia.	Authorised	yes	no	no	2016-06-21
Zoetis Belgium SA	SevoFlo	sevoflurane	EMEA/V/C/000072 For the induction and maintenance of anaesthesia in dogs and cats.	Authorised	no	no	no	2002-12-11

Sevoflurane Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sevoflurane

Introduction to Sevoflurane

Sevoflurane is a widely used volatile anesthetic agent, essential in various surgical procedures. Its market dynamics are influenced by several key factors, including the increasing number of surgeries, rising prevalence of chronic diseases, and advancements in healthcare technologies.

Market Size and Growth

The global sevoflurane market is projected to experience steady growth over the coming years. Here are some key financial projections:

• Current Market Size: The global sevoflurane market was valued at approximately USD 1370.6 million in 2023 and is expected to reach USD 1402.3 million by 2028, growing at a CAGR of 0.37% from 2023 to 2028[1].
• Alternative Projections: Another report estimates the market size to be around USD 400.7 million in 2024, with a CAGR of 4.4% from 2024 to 2031, reaching USD 542.2 million by 2031[3].

Market Drivers

Several factors are driving the growth of the sevoflurane market:

Increasing Number of Surgeries

The rising number of surgeries, particularly aesthetic and chronic disease-related procedures, is a significant driver. Approximately 320 million surgeries are performed annually, and this number is expected to increase, driving the demand for sevoflurane[1].

Rising Prevalence of Chronic Disorders

The increasing prevalence of chronic diseases such as cancer, respiratory diseases, and others is another major driver. For instance, an estimated 19.3 million new cancer cases were diagnosed worldwide in 2020, contributing to the demand for anesthesia agents like sevoflurane[3].

Advancements in Healthcare Technologies

Technological advancements in surgical procedures and anesthesia techniques also contribute to the market growth. The use of digital commerce platforms and the increasing preference for ambulatory surgical procedures are notable trends[1].

Distribution Channels

The market is segmented based on distribution channels, with the following trends observed:

Retail Pharmacies

The retail pharmacies segment is expected to grow at a healthy CAGR due to the increasing demand for convenient access to anesthesia products and the rising preference for ambulatory surgical procedures[1].

Online Pharmacies

Online pharmacies are also anticipated to dominate the market, having accounted for the largest market share (around 32.7% in 2022) and expected to grow at the fastest CAGR during the forecast period. The rapid use of digital commerce platforms has sustained the growth of this segment[1].

Hospital Pharmacies

Hospital pharmacies have traditionally dominated the market, with a significant market share. However, their growth is expected to be steady rather than exponential, as other channels gain traction[4].

Regional Analysis

The global sevoflurane market is geographically diverse, with different regions contributing significantly:

North America

North America is the dominant region, driven by the high number of surgeries, growing aging population, and advanced healthcare facilities. This region is expected to continue its leading position due to the high quality of surgical care in the United States[1][4].

Asia Pacific

The Asia Pacific region is the second largest and is expected to grow at the fastest CAGR. The increasing geriatric population and the rising number of surgeries performed in this region are key factors driving this growth[1].

Europe

Europe is the third largest region, with the UK holding the largest market share. Factors such as growing emphasis on patient safety, advancements in anesthesia techniques, and a rising geriatric population contribute to the market growth in this region[1].

Latin America and Middle East & Africa

These regions are also expected to grow at a healthy CAGR, driven by factors such as growing populations, aging demographics, rising healthcare expenditure, and government initiatives[1].

Key Market Players

Several notable players are active in the sevoflurane market:

• Baxter International Inc.
• AbbVie Inc.
• Piramal Enterprises Ltd.
• Fresenius Kabi AG
• Hikma Pharmaceuticals PLC
• Abbott Laboratories
• Maruishi Pharmaceutical Co., Ltd.
• Lunan Pharmaceutical Group
• Wellona Pharma
• Rewine Pharmaceutical
• Troikaa Pharmaceuticals Limited[1][3].

Financial Projections and Trends

Market Value Projections

• By 2028, the market is expected to reach nearly USD 1402.3 million[1].
• By 2031, the market is projected to reach USD 542.2 million, growing at a CAGR of 4.4% from 2024 to 2031[3].

Regional Market Value

• North America held a market share of around 38% and USD 140.6 billion in market revenue in 2021[4].

Distribution Channel Trends

• Online pharmacies are expected to grow at the fastest CAGR, while retail pharmacies and hospital pharmacies will also see significant growth[1][4].

Challenges and Restraints

Despite the growth drivers, the market faces some challenges:

• Competition from Alternative Anesthetics: The presence of other anesthetic agents like propofol can impact the market share of sevoflurane. For instance, studies comparing sevoflurane and propofol highlight different advantages and disadvantages of each[2].
• Regulatory and Safety Concerns: High-concentration sevoflurane exposure has been linked to certain adverse effects, which could influence regulatory approvals and usage guidelines[5].

Conclusion

The sevoflurane market is poised for steady growth driven by increasing surgical procedures, rising chronic disease prevalence, and advancements in healthcare technologies. While North America currently dominates the market, the Asia Pacific region is expected to grow rapidly. Key players are focusing on R&D and strategic partnerships to maintain their market position.

Key Takeaways

• The global sevoflurane market is expected to grow from USD 1370.6 million in 2023 to USD 1402.3 million by 2028.
• The increasing number of surgeries and rising prevalence of chronic diseases are major drivers.
• North America is the dominant region, but the Asia Pacific is expected to grow at the fastest CAGR.
• Online pharmacies and retail pharmacies are anticipated to grow significantly.
• Key players include Baxter International Inc., AbbVie Inc., and Fresenius Kabi AG.

FAQs

What is the current market size of the sevoflurane market?

The global sevoflurane market was valued at approximately USD 1370.6 million in 2023[1].

What is the expected CAGR of the sevoflurane market from 2023 to 2028?

The market is expected to grow at a CAGR of 0.37% from 2023 to 2028[1].

Which region dominates the sevoflurane market?

North America is the dominant region in the global sevoflurane market[1][4].

What are the key distribution channels for sevoflurane?

The key distribution channels include retail pharmacies, online pharmacies, and hospital pharmacies[1][4].

Which companies are major players in the sevoflurane market?

Major players include Baxter International Inc., AbbVie Inc., Piramal Enterprises Ltd., Fresenius Kabi AG, and Hikma Pharmaceuticals PLC[1][3].

Sources

1. MarketDataForecast: "Sevoflurane Market Worth USD 1402.3 Mn By 2028"[1].
2. Frontiers in Medicine: "Comparison of sevoflurane and propofol in combination with remifentanil for laparoscopic bariatric surgery"[2].
3. Coherent Market Insights: "Sevoflurane Market Size, Trends and Forecast to 2031"[3].
4. Spherical Insights: "Global Sevoflurane Market Outlook Forecasts to 2033"[4].
5. LWW Online: "High-concentration sevoflurane exposure in mid-gestation decreases VEGF, PI3K and p-AKT protein levels and induces cognitive dysfunction in offspring"[5].