Etomidate - Generic Drug Details

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

Etomidate is the generic ingredient in two branded drugs marketed by Hospira, Avet Lifesciences, Caplin, Endo Operations, Eugia Pharma, Gland Pharma Ltd, Hikma, Luitpold, Mylan Labs Ltd, Rising, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for etomidate. Fourteen suppliers are listed for this compound.

Summary for etomidate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	100
Patent Applications:	6,690
Drug Prices:	Drug price trends for etomidate
What excipients (inactive ingredients) are in etomidate?	etomidate excipients list
DailyMed Link:	etomidate at DailyMed

See drug prices for etomidate

Recent Clinical Trials for etomidate

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

Sponsor	Phase
Ahon Pharmaceutical Co., Ltd.	Phase 1
Hartford Hospital	Phase 4
Jason Chui	Phase 4

See all etomidate clinical trials

Pharmacology for etomidate

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for etomidate

Anesthetics, Intravenous

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for etomidate

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for etomidate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ETOMIDATE	etomidate	INJECTABLE;INJECTION	091297-001	Jun 20, 2012		DISCN	No	No
Eugia Pharma	ETOMIDATE	etomidate	INJECTABLE;INJECTION	206126-001	Feb 24, 2017	AP	RX	No	No
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227-001	Sep 7, 1982	AP	RX	Yes	Yes
Hikma	ETOMIDATE	etomidate	INJECTABLE;INJECTION	074593-001	Nov 4, 1996	AP	RX	No	No
Luitpold	ETOMIDATE	etomidate	INJECTABLE;INJECTION	078867-001	Dec 22, 2009		DISCN	No	No
Zydus Pharms	ETOMIDATE	etomidate	INJECTABLE;INJECTION	202360-001	Jul 18, 2014	AP	RX	No	No
Caplin	ETOMIDATE	etomidate	INJECTABLE;INJECTION	215028-001	Dec 18, 2020	AP	RX	No	No

Etomidate Market Analysis and Financial Projection Experimental

Etomidate Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The etomidate market is poised for significant growth over the next decade. As of 2023, the global etomidate market was valued at approximately $2.3 billion and is projected to reach $3.2 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2033[1].

Another forecast suggests that the etomidate market could be even larger, with some reports indicating a market size of $5 billion in 2023, expected to grow to $8.59 billion by 2031 at a CAGR of 7%[4].

Key Drivers of Market Growth

Increasing Number of Surgical Procedures

The rising number of surgical procedures globally is a major driver of the etomidate market. Approximately 313 million surgical procedures are undertaken worldwide each year, driven by the increasing prevalence of chronic diseases and an aging population[1].

Demand for Effective Anesthetics

The growing demand for safe and effective sedatives in hospitals and surgical centers is another significant factor. Etomidate's rapid onset and short duration of action, along with its minimal cardiovascular effects, make it an ideal choice for various surgeries, particularly in emergency and short-term cases[1][2].

Advancements in Healthcare Infrastructure

The expanding healthcare infrastructure and increasing investment in healthcare within emerging markets present significant growth opportunities. Governments and private sectors are prioritizing the enhancement of medical facilities and accessibility, leading to a higher demand for effective anesthetics like etomidate[1].

Regional Market Dynamics

North America

The etomidate market in North America is expected to develop significantly due to the region's advanced healthcare infrastructure, high incidence of chronic conditions, and high healthcare spending. The U.S. plays a crucial role in this market, driven by its well-established medical facilities and the rising geriatric population[1].

Asia-Pacific

The Asia-Pacific region is anticipated to account for the largest revenue share by 2036, driven by favorable government policies and rapidly growing healthcare infrastructure. This region's growing demand for etomidate in emergency and surgical procedures is a key factor in its market dominance[3].

Market Segmentation

By Product Type

The market is segmented by product type, with the fat emulsion segment expected to acquire the largest share during the forecast period. This is due to the lesser side effects associated with drug administration via fat emulsion formulation and its role in energy metabolism and storage during operations[3].

By End User

The ambulatory surgical centers segment is anticipated to hold the largest share in the global etomidate market, driven by the high usage of etomidate during trauma and cardiovascular emergencies[3].

Competitive Landscape

The etomidate market is competitive, with several key players operating globally. These include Luitpold Pharmaceuticals, Mylan, Par Sterile Products, Krka, Johnson & Johnson, AbbVie, Abbott, Teva, Zydus, and Esteve Pharma. These companies are involved in ongoing research and development to enhance the formulations and delivery methods of etomidate[1].

Financial Trajectory

Revenue Growth

The etomidate market is expected to witness steady revenue growth, driven by the increasing demand for effective anesthetic drugs and the growing number of surgical procedures. The market is projected to grow from $2.3 billion in 2023 to $3.2 billion by 2033, with some forecasts suggesting even higher growth rates and larger market sizes[1][4].

Investment and R&D

The market growth is also fueled by significant investments in research and development. Pharmaceutical companies are focusing on developing new formulations and delivery methods for etomidate, which is expected to further boost market growth[1][3].

Challenges and Opportunities

Adverse Effects

Despite its benefits, etomidate has several adverse effects, including transient inhibition of adrenal steroid synthesis, which can lead to adrenocortical suppression. This poses a theoretical risk of impairing a patient's ability to produce an adequate stress response. However, most patients' suppression resolves within 48 hours[2].

Growing Research and Development

The ongoing research into new formulations and delivery methods presents ample growth opportunities for the market. For instance, the use of fat emulsion formulations is gaining traction due to their lesser side effects and role in energy metabolism during operations[3].

Special Populations and Usage

Hepatic and Renal Impairment

Etomidate's pharmacokinetics vary in patients with hepatic or renal impairment. For example, patients with cirrhosis and esophageal varices have a higher volume of distribution and elimination half-life compared to healthy subjects. In patients with renal impairment, the risk of toxic reactions may be greater due to the primary excretion of etomidate by the kidneys[2].

Animal Testing

Etomidate is also widely used in animal testing and experiments, which is expected to contribute to market growth. The increasing number of animal tests, particularly in regions like the United States, will drive the demand for etomidate in the coming years[3].

Key Takeaways

• The etomidate market is driven by the increasing number of surgical procedures and the demand for effective anesthetics.
• The market is expected to grow significantly, with a projected value of $3.2 billion by 2033.
• North America and Asia-Pacific are key regions driving market growth.
• The fat emulsion segment and ambulatory surgical centers are significant market segments.
• Ongoing research and development in new formulations and delivery methods are crucial for market growth.
• Adverse effects, such as adrenal suppression, are significant challenges that need to be managed.

Frequently Asked Questions (FAQs)

Q: What are the primary drivers of the etomidate market growth? A: The primary drivers include the increasing number of surgical procedures, demand for effective anesthetics, and advancements in healthcare infrastructure.

Q: Which region is expected to dominate the etomidate market by 2036? A: The Asia-Pacific region is anticipated to account for the largest revenue share by 2036.

Q: What are the common adverse effects associated with etomidate? A: Common adverse effects include transient inhibition of adrenal steroid synthesis, postoperative nausea and vomiting, and minimal effects on hemodynamics.

Q: How does etomidate's pharmacokinetics vary in patients with hepatic or renal impairment? A: Patients with cirrhosis and esophageal varices have a higher volume of distribution and elimination half-life, while patients with renal impairment are at a greater risk of toxic reactions.

Q: What is the role of etomidate in animal testing and experiments? A: Etomidate is widely used in animal testing, particularly in regions like the United States, and this usage is expected to contribute to market growth.

Cited Sources:

1. Allied Market Research - Etomidate Market Size, Share and Growth Report, 2033
2. NCBI Bookshelf - Etomidate - StatPearls
3. Research Nester - Etomidate Market Size, Forecast Report 2036
4. Market Research Intellect - Etomidate Injection Market Size and Projections
5. DrugBank Online - Etomidate: Uses, Interactions, Mechanism of Action