Last Updated: September 28, 2026

etomidate - Profile


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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.

Summary for etomidate
US Patents:0
Tradenames:2
Applicants:11
NDAs:12

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
Hospira AMIDATE etomidate INJECTABLE;INJECTION 018227-001 Sep 7, 1982 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Avet Lifesciences ETOMIDATE etomidate INJECTABLE;INJECTION 204618-001 Aug 13, 2014 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Caplin ETOMIDATE etomidate INJECTABLE;INJECTION 215028-001 Dec 18, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Eugia Pharma ETOMIDATE etomidate INJECTABLE;INJECTION 206126-001 Feb 24, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gland ETOMIDATE etomidate INJECTABLE;INJECTION 209058-001 Apr 18, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma ETOMIDATE etomidate INJECTABLE;INJECTION 074593-001 Nov 4, 1996 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Etomidate (Etomidate Injection): Investment Scenario and Fundamentals Analysis

Last updated: April 23, 2026

What does etomidate’s commercial baseline look like?

Etomidate is a short-acting intravenous anesthetic used primarily for induction of anesthesia. In practice, it is also used for procedural sedation in acute settings where rapid onset and predictable anesthesia depth matter.

From an investment standpoint, etomidate’s market fundamentals are shaped by two forces:

  1. Mature, established product base with a long history of use and entrenched clinician protocols.
  2. Generic competition across major markets, which compresses pricing and margins unless a company has differentiated positioning, supply strength, or protected reformulations.

Demand and usage profile (what drives volume)

Etomidate’s utilization tracks to:

  • Surgery and procedural anesthesia volumes (hospital and ambulatory surgical centers for anesthesia induction)
  • Emergency and critical care workflows (especially where rapid onset is valued)
  • Substitution dynamics within anesthetic induction classes (propofol and others compete on clinician preference, safety perceptions, and formulary access)

Pricing and margin structure (what drives profitability)

Because etomidate is an established molecule, revenue growth typically does not come from first-in-class adoption. It comes from:

  • Formulary access wins (hospital group purchasing outcomes)
  • Tender wins in hospital supply chains
  • Supply reliability that reduces stockout risk
  • Manufacturing scale and cost position that supports competitive pricing

How does the patent and regulatory landscape shape investment returns?

Etomidate is not positioned like a late-stage pipeline asset. The investment question is mostly about product-level durability (market access) and brand or supply differentiation (not molecular exclusivity).

Key investment implication

  • Most value creation depends on market share capture under generic competition, and on regulatory and manufacturing execution, not on long-run patent-driven monopoly pricing.

Practical patent lens for investors

When molecule-level protection expires, the payoffs concentrate into:

  • ANDA-driven generics and authorized generic supply strategies
  • Pediatric/label expansions (where available for specific products)
  • Formulation-level differentiation (where one exists and is protected)
  • Market-specific exclusivities for the first successful applicant in a given filing scenario

Without a product-specific filing map and patent list tied to particular marketed presentations, the correct investment interpretation is: etomidate should be treated as high operational leverage and low patent leverage.


What are the core commercial risks?

1) Generic price compression

Entry by additional generic manufacturers typically forces:

  • Lower WAC-to-NAD pricing dynamics
  • Margin degradation from manufacturing price pressure
  • Increased customer concentration risk at group purchasing organizations

2) Substitution away from etomidate in some protocols

Even when etomidate remains in the armamentarium, anesthetic induction decisions can shift based on:

  • Side-effect profile perceptions
  • Institutional practice patterns
  • Availability of alternatives and bundled anesthesia kits

3) Supply chain and manufacturing scrutiny

Injectables face:

  • Stricter quality system costs
  • Batch release timing risk
  • Temperature excursion and cold-chain logistics (product-dependent)

4) Safety and labeling pressure

Etomidate has a distinct safety profile versus other induction agents. Any label friction, safety communications, or guideline changes can shift utilization at the margin.


What are the core commercial upside levers?

1) Formulary access through hospital procurement

The most durable upside for etomidate comes from:

  • Getting on preferred drug lists for induction or procedural sedation
  • Retaining status amid periodic procurement cycles

2) Competitive cost position

If a manufacturer can produce with lower unit costs and stable lead times, it can:

  • Win share in cost-down tenders
  • Preserve gross margin versus weaker competitors

3) Product execution and continuity of supply

In hospital formularies, stockouts can lead to substitution. The firm that reliably supplies etomidate is more likely to retain usage.

4) Franchise adjacency

Etomidate sits in a class of perioperative IV anesthetics. Companies with strong perioperative portfolios can cross-leverage:

  • Hospital relationships
  • Pharmacy and anesthesia contracting infrastructure

How should investors underwrite etomidate: base case, bull case, bear case?

Given its mature status and expected generic saturation, underwriting should emphasize market share, supply reliability, and unit margin.

Base case (most likely)

  • Etomidate volume stays stable to modestly growing with procedural anesthesia volumes.
  • Pricing trends stay downward or flat-to-down due to generics.
  • Returns depend on maintaining share and controlling unit costs.

Bull case (share capture)

  • Market share rises through procurement wins.
  • Unit economics stabilize as manufacturing improvements offset price erosion.
  • Slight margin improvement through operational excellence and scale.

Bear case (margin collapse)

  • Additional generic entrants force price reductions.
  • Tender outcomes favor lower-cost suppliers.
  • Supply constraints or quality events reduce utilization and lead to substitution.

What should investors watch in quarterly fundamentals?

For an etomidate investment thesis centered on product execution, investors should track:

  • Net sales growth vs procedural volume proxies (volume vs price decomposition)
  • Gross margin trend (pricing pressure vs cost improvements)
  • Utilization/shipments stability (backorder risk or allocation signals)
  • Customer concentration (tender cycle exposure)
  • Regulatory or quality events affecting batch release

How does etomidate compare with other induction agents from an investment angle?

Induction agents compete within anesthesia formulary decisions. The competitive set typically includes propofol and other IV induction drugs.

Investment comparison framework

  • Patent leverage: generally low for etomidate if molecule protection has lapsed, similar to other older generics
  • Operational leverage: high for etomidate because sales depend on supply and pricing execution
  • Formulary stickiness: varies by institution; etomidate’s role can be narrow or protocol-specific
  • Substitution risk: meaningful because anesthesia teams can shift to alternatives on perceived safety and guideline alignment

Takeaway for portfolio construction

Etomidate is more like an injectable branded/generic manufacturing and contracting story than a biotech-like pipeline story.


What are the practical due-diligence targets before investing?

Focus diligence on items that determine whether a manufacturer can keep share and protect margins:

  1. Manufacturing footprint
    • Batch consistency, yield, and release timelines
  2. Supply reliability
    • History of backorders and allocation behavior
  3. Pricing and contracting terms
    • Hospital group purchasing agreements and tender cadence
  4. Regulatory standing
    • Compliance record and inspection outcomes for the manufacturing sites
  5. Portfolio strategy
    • Whether the firm uses perioperative adjacency to defend contracting relationships

Key Takeaways

  • Etomidate is a mature IV anesthetic whose investment returns rely primarily on formulary access and manufacturing execution, not on long-duration patent exclusivity.
  • Generic competition compresses pricing, so the underwriting center of gravity shifts to share stability, supply reliability, and unit cost control.
  • The main upside lever is procurement-driven market share gain; the main downside is margin erosion from further entrants or tender losses.
  • Investors should underwrite etomidate as a product-level operational equity story with quarterly monitoring concentrated on gross margin, shipments, and customer contracting exposure.

FAQs

1) Is etomidate a pipeline-style investment?

No. Etomidate is best treated as a mature commercial injectable investment where success comes from market access and operational execution.

2) What most strongly drives revenue for etomidate?

The dominant drivers are hospital purchasing outcomes and procedural anesthesia demand, with pricing shaped by generic competitive intensity.

3) What is the biggest risk to returns?

Generic price compression plus the risk of losing share in tender cycles, which can drive gross margin decline.

4) What matters most for due diligence?

Confirm manufacturing reliability, regulatory compliance, and contracting position in major hospital accounts.

5) Where can growth realistically come from?

From share gains in preferred formularies, improved unit economics, and continuity of supply rather than new-molecule adoption.


References (APA)

[1] FDA. (n.d.). Labeling for etomidate (products may vary by manufacturer/presentation). U.S. Food and Drug Administration. https://www.fda.gov/drugs

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