ENFLURANE - Generic Drug Details

What are the generic sources for enflurane and what is the scope of patent protection?

Enflurane is the generic ingredient in two branded drugs marketed by Abbott, Piramal Critical, and Baxter Hlthcare, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for enflurane.

Summary for ENFLURANE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	3
Patent Applications:	2,935
DailyMed Link:	ENFLURANE at DailyMed

Recent Clinical Trials for ENFLURANE

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

Sponsor	Phase
RWTH Aachen University	Phase 4
Penn State University	Phase 4
University of Leipzig	Phase 4

See all ENFLURANE clinical trials

Medical Subject Heading (MeSH) Categories for ENFLURANE

Anesthetics, Inhalation

Anatomical Therapeutic Chemical (ATC) Classes for ENFLURANE

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

US Patents and Regulatory Information for ENFLURANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	ENFLURANE	enflurane	LIQUID;INHALATION	070803-001	Sep 8, 1987		DISCN	No	No
Piramal Critical	ENFLURANE	enflurane	LIQUID;INHALATION	074396-001	Jul 29, 1994		DISCN	No	No

Expired US Patents for ENFLURANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982
Baxter Hlthcare	ETHRANE	enflurane	LIQUID;INHALATION	017087-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Enflurane

Introduction to Enflurane

Enflurane is a halogenated ether used as an inhalational anesthetic agent. It has been a part of the anesthesia arsenal for several decades, known for its efficacy in inducing and maintaining general anesthesia. Here, we will delve into the market dynamics and financial trajectory of enflurane, exploring its current status, future projections, and the factors influencing its market.

Current Market Size and Valuation

As of 2023, the enflurane market was valued at USD 206.39 million. This valuation is part of a broader trend in the general anesthesia drugs market, which itself was estimated at USD 4,978.1 million in 2023[1][3].

Growth Projections

The enflurane market is expected to grow, albeit at a moderate pace. For 2024, the market is projected to reach USD 215.70 million, indicating a steady but not spectacular growth rate. Over the longer term, the market is anticipated to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent until 2031[1][4].

Market Drivers

Several factors are driving the growth of the enflurane market:

Increasing Surgical Procedures

The rise in the number of surgical operations globally, particularly in regions with robust healthcare infrastructures like North America and Europe, is a significant driver. As the population ages and chronic illnesses become more prevalent, the demand for surgical procedures and, by extension, anesthesia drugs like enflurane is expected to increase[3].

Healthcare Infrastructure

Countries with well-developed healthcare systems, such as the United States, Germany, and Japan, contribute substantially to the demand for enflurane. These countries have high rates of surgical procedures and a strong focus on healthcare spending, which supports the market for anesthesia drugs[3].

Technological Advancements

Improvements in anesthetic technology and the development of more efficient delivery systems are also driving the market. These advancements make anesthesia safer and more effective, which can increase the adoption of enflurane and other anesthesia drugs[3].

Market Challenges

Despite the growth drivers, there are several challenges facing the enflurane market:

Environmental Concerns

Enflurane, like other inhalational anesthetics, is a potent greenhouse gas. The healthcare sector is under increasing pressure to reduce its environmental footprint, which could lead to increased scrutiny and potential regulations on the use of enflurane and other halogenated anesthetics[2].

Competition from Other Anesthetics

The general anesthesia drugs market is highly competitive, with various drugs such as propofol, sevoflurane, and desflurane vying for market share. Propofol, in particular, dominated the market in 2022 with a 25.8% share, which could pose a challenge to enflurane's growth[3].

Accessibility in Low-Income Countries

The lack of healthcare services in low-income countries and remote areas limits the demand for anesthesia drugs, including enflurane. This gap in accessibility affects the overall market size and growth potential[3].

Route of Administration

Enflurane is administered via inhalation, which is a significant segment within the general anesthesia drugs market. However, the intravenous anesthesia segment currently dominates the market with a 64.5% share in 2022. The preference for intravenous anesthesia over inhaled anesthesia could impact the growth trajectory of enflurane[3].

Regional Market Dynamics

• North America: This region, particularly the United States, is a major market for enflurane due to its robust healthcare infrastructure and high prevalence of surgical procedures[3].
• Europe: Countries like Germany have a significant share in the market, driven by their well-established pharmaceutical industry and stringent regulatory frameworks[3].
• Japan: Known for its aging population and high healthcare expenses, Japan is another key market where the demand for enflurane is expected to rise[3].

Financial Trajectory

The financial trajectory of enflurane is closely tied to the broader trends in the general anesthesia drugs market. Here are some key financial highlights:

• Current Valuation: USD 206.39 million in 2023[1].
• Projected Valuation: USD 215.70 million in 2024[1].
• Long-term Growth: Expected to grow at a CAGR of 3 to 5 percent until 2031[4].

Key Takeaways

• The enflurane market is valued at USD 206.39 million in 2023 and is expected to grow moderately.
• The market is driven by increasing surgical procedures, robust healthcare infrastructure, and technological advancements.
• Environmental concerns and competition from other anesthetics are significant challenges.
• The intravenous anesthesia segment dominates the market, which could impact enflurane's growth.
• North America, Europe, and Japan are key regions driving the demand for enflurane.

FAQs

1. What is the current market size of enflurane? The enflurane market was valued at USD 206.39 million in 2023[1].

2. What is the projected growth rate of the enflurane market? The enflurane market is expected to grow at a CAGR of 3 to 5 percent until 2031[4].

3. What are the main drivers of the enflurane market? The main drivers include increasing surgical procedures, robust healthcare infrastructure, and technological advancements in anesthesia delivery[3].

4. What are the environmental concerns associated with enflurane? Enflurane is a potent greenhouse gas, contributing to the healthcare sector's environmental footprint. This has led to increased scrutiny and potential regulations on its use[2].

5. Which regions are the most significant markets for enflurane? North America, particularly the United States, Europe, especially Germany, and Japan are the most significant markets for enflurane[3].

Sources

1. GII Research: Enflurane Market by Route of Administration, End-Use.
2. The Lancet: Assessing the potential climate impact of anaesthetic gases.
3. Future Market Insights: General Anesthesia Drugs Market Size, Trends - 2033.
4. Market Research Intellect: Enflurane Market Size and Forecast.