ISOFLURANE - Generic Drug Details

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

Isoflurane is the generic ingredient in two branded drugs marketed by Baxter Hlthcare, Halocarbon Prods, Hospira, Piramal Critical, Piramal Pharma, and Watson Labs Inc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for isoflurane. Four suppliers are listed for this compound.

Summary for ISOFLURANE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	238
Patent Applications:	7,433
What excipients (inactive ingredients) are in ISOFLURANE?	ISOFLURANE excipients list
DailyMed Link:	ISOFLURANE at DailyMed

Recent Clinical Trials for ISOFLURANE

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

Sponsor	Phase
Jason Chui	Phase 4
West China Hospital	N/A
National Trauma Center	N/A

See all ISOFLURANE clinical trials

Pharmacology for ISOFLURANE

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for ISOFLURANE

Anesthetics, Inhalation

Anatomical Therapeutic Chemical (ATC) Classes for ISOFLURANE

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

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
Piramal Critical	ISOFLURANE	isoflurane	LIQUID;INHALATION	074416-001	Sep 30, 1994	AN	RX	No	No
Piramal Pharma	ISOFLURANE	isoflurane	LIQUID;INHALATION	074502-001	Jun 27, 1995	AN	RX	No	No
Baxter Hlthcare	FORANE	isoflurane	LIQUID;INHALATION	017624-001	Approved Prior to Jan 1, 1982	AN	RX	Yes	Yes
Hospira	ISOFLURANE	isoflurane	LIQUID;INHALATION	074097-001	Jan 25, 1993		DISCN	No	No

Expired US Patents for ISOFLURANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	FORANE	isoflurane	LIQUID;INHALATION	017624-001	Approved Prior to Jan 1, 1982
Baxter Hlthcare	FORANE	isoflurane	LIQUID;INHALATION	017624-001	Approved Prior to Jan 1, 1982

ISOFLURANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isoflurane

Introduction to Isoflurane

Isoflurane is a widely used inhalation anesthetic, employed for the induction and maintenance of general anesthesia in surgical procedures. It is known for its stability, non-explosive nature, and relatively minimal side effects[4].

Global Market Size and Growth

The global isoflurane market is projected to experience significant growth over the coming years. As of 2024, the market size is estimated to be USD XX million and is expected to expand at a compound annual growth rate (CAGR) of 4.60% from 2024 to 2031[1].

Regional Market Dynamics

North America

North America holds a substantial share of the global isoflurane market, accounting for more than 40% of the global revenue. However, the region is expected to grow at a relatively slower CAGR of 2.8% from 2024 to 2031[1].

Europe

Europe also constitutes a significant portion of the global market, with over 30% of the global revenue. The European market is anticipated to grow at a CAGR of 3.1% during the same period[1].

Asia Pacific

The Asia Pacific region stands out as the fastest-growing market for isoflurane, driven by rapid urbanization, economic development, and an increasing geriatric population. This region is expected to grow at a CAGR of 6.6% from 2024 to 2031, making it a crucial area for market expansion[1].

South America and Middle East & Africa

South America and the Middle East & Africa are also growing markets, with CAGRs of 4.0% and 4.3%, respectively, from 2024 to 2031[1].

Market Segmentation

The isoflurane market is segmented based on formulation, type, and application. Understanding these segments is crucial for identifying the most lucrative areas and future market opportunities.

• Formulation: The market is segmented into different formulations, each catering to specific clinical needs.
• Type: Isoflurane is part of the broader inhalation anesthesia market, which includes other agents like sevoflurane. Sevoflurane, for instance, is expected to grow at a CAGR of 7.47% due to its favorable pharmacokinetic properties[3].
• Application: Isoflurane is used in various surgical settings, including outpatient and same-day discharge procedures, which are increasingly common and drive the demand for anesthetics with fast recovery times[3].

Drivers and Restraints

Drivers

• Increasing Surgical Procedures: The global rise in surgical procedures, particularly in outpatient settings, is a significant driver for the isoflurane market.
• Growing Geriatric Population: An aging population increases the need for surgical interventions, thereby boosting the demand for anesthesia agents.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in the Asia Pacific region, enhance market penetration and adoption rates[1].

Restraints

• Regulatory Frameworks: Evolving regulatory frameworks can sometimes pose challenges to market growth.
• Economic Factors: Economic downturns and high inflation rates can impact healthcare spending and, consequently, the demand for isoflurane[2].

Competitive Landscape

The isoflurane market is characterized by several key players, including:

• Baxter International Inc.: Known for its brand "Forane," Baxter is a major player in the inhalation anesthesia market[2][4].
• Halocarbon Life Sciences: Recently, Dechra acquired isoflurane and sevoflurane products from Halocarbon Life Sciences, indicating significant market activity[3].
• SunMed: SunMed's acquisition of Vyaire Medical’s anesthesia business highlights the consolidation and expansion strategies in the market[2].

Mergers and Acquisitions

Recent mergers and acquisitions, such as SunMed's acquisition of Vyaire Medical and Dechra's acquisition of isoflurane and sevoflurane products from Halocarbon Life Sciences, are reshaping the market landscape. These moves aim to create comprehensive offerings and strengthen market positions[2][3].

Financial Performance and Outlook

The financial trajectory of the isoflurane market is positive, driven by the increasing demand for anesthesia agents in surgical procedures. Here are some key financial insights:

• Global Market Size: Estimated at USD XX million in 2024, with a projected CAGR of 4.60% from 2024 to 2031[1].
• Regional Growth: Asia Pacific is expected to be the fastest-growing region, while North America and Europe will continue to hold significant market shares[1].

Future Outlook

The future outlook for the isoflurane market is promising, with several factors contributing to its growth:

• Expanding Healthcare Infrastructure: Continued investments in healthcare infrastructure, especially in emerging markets, will drive demand.
• Technological Advancements: Innovations in anesthesia monitoring devices and the development of more efficient and safe anesthetics will further propel the market[2].

"The Asia-Pacific stands out as the fastest-growing region in the Isoflurane market due to various compelling factors. Firstly, rapid urbanization and economic development lead to improved access to healthcare services, spurring demand for anesthesia agents in surgical procedures."[1]

Key Takeaways

• The global isoflurane market is expected to grow at a CAGR of 4.60% from 2024 to 2031.
• Asia Pacific is the fastest-growing region, driven by urbanization and an increasing geriatric population.
• The market is segmented by formulation, type, and application, with sevoflurane being a significant competitor.
• Key drivers include increasing surgical procedures and advancements in healthcare infrastructure.
• The competitive landscape is marked by significant mergers and acquisitions.

FAQs

What is the projected CAGR for the global isoflurane market from 2024 to 2031?

The global isoflurane market is expected to grow at a CAGR of 4.60% from 2024 to 2031[1].

Which region is expected to be the fastest-growing for isoflurane?

The Asia Pacific region is anticipated to be the fastest-growing, with a CAGR of 6.6% from 2024 to 2031[1].

What are the key drivers for the isoflurane market?

Key drivers include the increasing number of surgical procedures, a growing geriatric population, and advancements in healthcare infrastructure[1].

Who are some of the major players in the isoflurane market?

Major players include Baxter International Inc., Halocarbon Life Sciences, and SunMed[2][3].

What recent mergers and acquisitions have impacted the isoflurane market?

Recent acquisitions include SunMed's acquisition of Vyaire Medical and Dechra's acquisition of isoflurane and sevoflurane products from Halocarbon Life Sciences[2][3].

Sources

1. Cognitive Market Research: Isoflurane Market Report 2024.
2. The Business Research Company: Anesthesia Monitoring Devices Global Market Report 2024.
3. Grand View Research: Inhalation Anesthesia Market Size And Share Report, 2030.
4. DrugBank Online: Isoflurane: Uses, Interactions, Mechanism of Action.