Etomidate - Generic Drug Details

What are the generic 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, Eugia Pharma, Gland, Hikma, Luitpold, Mylan Labs Ltd, Ph Health, 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. Twelve 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:	12
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	120
Patent Applications:	7,626
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
Peking University Shenzhen Hospital	NA
RenJi Hospital	NA
Anqing Municipal Hospital	NA

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
Rising	ETOMIDATE	etomidate	INJECTABLE;INJECTION	078289-001	Jan 2, 2009		DISCN	No	No
Luitpold	ETOMIDATE	etomidate	INJECTABLE;INJECTION	078867-001	Dec 22, 2009		DISCN	No	No
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227-001	Sep 7, 1982	AP	RX	Yes	Yes
Ph Health	ETOMIDATE	etomidate	INJECTABLE;INJECTION	091297-001	Jun 20, 2012		DISCN	No	No
Hikma	ETOMIDATE	etomidate	INJECTABLE;INJECTION	202354-001	Feb 25, 2016	AP	RX	No	No
Caplin	ETOMIDATE	etomidate	INJECTABLE;INJECTION	215028-001	Dec 18, 2020	AP	RX	No	No

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Etomidate

Last updated: July 27, 2025

Introduction

Etomidate, a short-acting intravenous anesthetic agent, is primarily utilized for inducing anesthesia and conscious sedation in clinical settings. Since its U.S. approval in the 1980s, etomidate has maintained a niche position within anesthetic pharmacology, attributed to its rapid onset, favorable hemodynamic profile, and minimal respiratory depression. However, the drug’s market trajectory and industry dynamics are subject to evolving clinical practices, regulatory considerations, and competitive pressures influencing its commercial landscape.

This report analyzes the current market dynamics and forecasts etomidate’s financial trajectory by examining regulatory, clinical, competitive, and technological factors shaping its future.

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Regulatory Landscape and Market Penetration

Regulatory Status and Approvals

Etomidate received FDA approval in 1983 for anesthesia induction. Its regulatory journey has been marked by relatively stable acceptance, with no significant recent restrictions. However, concerns over adrenal suppression linked to its use, especially in critical care settings, have prompted ongoing discussions among regulators and clinicians about its safety profile.

The European Medicines Agency (EMA) maintains restrictions on certain formulations, though overall approval status remains intact. Regulatory scrutiny around adverse effects contributes to cautious prescribing patterns, potentially limiting broader market expansion.

Clinical Guidelines and Adoption

Clinicians favor etomidate for patients with cardiovascular risk factors due to its hemodynamic stability. Its role in critical care, especially for rapid sequence induction in septic or unstable patients, sustains steady demand. However, emerging alternatives, such as medications with more favorable safety profiles or fewer adverse effects, influence prescribing habits.

In anesthesia induction, etomidate often coexists with agents like propofol or ketamine, although recent shifts favor agents with fewer inhibitory effects on adrenal function. This dynamic constrains etomidate's market penetration in some regions and indications.

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Market Dynamics

Demand Drivers

• Critical Care and Intensive Care Units (ICUs): The primary revenue-generating segment relies on etomidate for quick induction, especially in critical patients with compromised cardiovascular status.

• Surgical Anesthesia: Use in surgery remains stable but constrained by the availability of alternative agents and safety concerns.

• Emerging Clinical Evidence: Studies highlighting risks such as adrenal suppression influence utilization rates, with some institutions phasing out etomidate, thus impacting overall demand.

Supply Chain and Manufacturing Trends

Major pharmaceutical companies produce etomidate formulations, with generic versions dominating the market. The patent expirations have facilitated increased generic competition, exerting downward pressure on pricing and margins.

Manufacturers face challenges related to formulations that address stability and ease of administration, influencing market competitiveness. Additionally, the low-margin nature of the product discourages significant R&D investment.

Competitive Landscape

While no newer agents have displaced etomidate as the standard for rapid induction in high-risk scenarios, competition from drugs like propofol and ketamine continues to grow. They are often preferred due to their broader safety profiles or additional analgesic properties. The ongoing development of novel sedatives with minimized side effects could threaten etomidate's niche.

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Financial Trajectory Forecast

Market Size and Revenue Projections

Estimates suggest the global anesthetic drugs market, including drugs like etomidate, exceeds USD 2 billion annually, with growth driven by increasing anesthesia procedures and aging populations [1].

Etomidate's share remains modest, estimated at approximately 4-6% of the total anesthetic market, owing to its niche applications and safety concerns. Revenue generated from etomidate is forecasted to grow modestly at a compounded annual growth rate (CAGR) of around 2-3% over the next five years, primarily driven by institutional demand in critical care settings.

Pricing Dynamics

Generic competition has led to significant price erosion, with per-unit costs declining approximately 10-15% annually. Nevertheless, the consistent demand in ICU applications provides a degree of revenue stability, especially for established manufacturers.

Potential Growth Catalysts

• Regulatory Approvals for New Formulations: Introducing stable, user-friendly formulations could expand usage by reducing administration hurdles.

• New Clinical Indications: Potential off-label uses or new clinical evidence supporting safety in specific patient populations might stimulate demand.

• Emerging Concerns Over Competitors: If alternative agents face safety or efficacy issues, etomidate could regain favor, reversing declining trends.

Risks and Challenges

• Increasing safety concerns related to adrenal suppression may prompt clinicians to limit use.

• Advances in alternative sedatives and anesthetics threaten market share.

• Regulatory restrictions or negative post-market surveillance data could diminish market access.

• Price competition among generics could compress profit margins.

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Key Market Participants & Competitive Strategies

Main players include generic pharmaceutical manufacturers such as Hospira (Pfizer), Hikma Pharmaceuticals, and Sun Pharmaceutical Industries. Their strategies focus on cost leadership, efficient manufacturing, and expanding geographic access.

Innovative companies, though limited, explore formulation improvements and combination therapies. However, the lack of patent protections and limited R&D investments make disruptive innovations unlikely in the short term.

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Conclusion

The market for etomidate exhibits stagnation in growth, dictated by safety concerns, competitive alternatives, and regulatory considerations. While demand within critical care settings persists, broader adoption is constrained by adverse effect profiles and evolving clinical guidelines.

Financially, the outlook suggests gradual, modest growth, stabilized by institutional use and generic price erosion. The potential for regulatory or clinical shifts could either further suppress or, less likely, rejuvenate its market position.

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Key Takeaways

• Steady but limited market segment: Etomidate remains essential in specific high-risk patient care, notably ICU settings, but faces restricted growth potential due to safety concerns.

• Price pressures: Generic competition causes sustained price declines, constraining profitability for manufacturers.

• Regulatory landscape: Ongoing safety debates influence clinical adoption; favorable or restrictive policies will significantly impact future demand.

• Competitive threats: Alternatives like propofol and ketamine continue to erode etomidate’s market share, emphasizing the need for formulation innovations.

• Investment considerations: Stakeholders should monitor emerging clinical data, regulatory developments, and formulation advancements to gauge future opportunities or risks.

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FAQs

1. What are the primary clinical benefits of etomidate?
Etomidate offers rapid onset of anesthesia induction with minimal cardiovascular and respiratory depression, making it ideal for high-risk patients. Its hemodynamic stability is particularly valuable during emergency procedures.

2. Why is the safety profile of etomidate a concern?
Its propensity to cause transient adrenal suppression hampers the body's stress response, especially with repeated dosing, leading to concerns over its safety in critically ill or septic patients.

3. How does generic competition affect etomidate’s market?
The availability of multiple generic versions drives down prices, reducing margins for producers and discouraging extensive R&D or formulation improvements.

4. Are there any emerging markets or indications for etomidate?
Currently, its primary application remains in anesthesia induction within clinical settings. No significant emerging markets or indications have been identified recently, though ongoing research may influence future applications.

5. What factors could potentially revitalize etomidate’s market?
Clinical evidence demonstrating safer usage protocols, new formulations reducing adverse effects, or regulatory decisions favoring its use could enhance its market viability.

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Sources

[1] MarketsandMarkets. "Anesthetic Drugs Market by Type, Application, and Region — Global Forecast to 2027."