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Last Updated: December 14, 2025

AMIDATE Drug Patent Profile


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When do Amidate patents expire, and when can generic versions of Amidate launch?

Amidate is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in AMIDATE is etomidate. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the etomidate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amidate

A generic version of AMIDATE was approved as etomidate by HIKMA on November 4th, 1996.

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Summary for AMIDATE
Drug patent expirations by year for AMIDATE
Drug Prices for AMIDATE

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Recent Clinical Trials for AMIDATE

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

SponsorPhase
South East Area Health Education Center, Wilmington, NCPhase 4
New Hanover Regional Medical CenterPhase 4
University of California, DavisPhase 4

See all AMIDATE clinical trials

Pharmacology for AMIDATE
Drug ClassGeneral Anesthetic
Physiological EffectGeneral Anesthesia

US Patents and Regulatory Information for AMIDATE

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for AMIDATE (Etomidate)

Last updated: July 30, 2025

Introduction

AMIDATE, the trade name for etomidate, is an intravenous anesthetic agent primarily used for rapid induction of anesthesia and sedation in various clinical settings. Since its approval, AMIDATE’s market trajectory has been influenced by evolving clinical needs, regulatory landscapes, technological advances, and competitive dynamics within the anesthetic and critical care pharmacology markets. This analysis explores the current market environment, growth drivers, challenges, and future financial outlook for AMIDATE as a pharmaceutical asset.

Market Overview

The global anesthetic and sedative drugs market comprises several key players and products, with agents like propofol, midazolam, and etomidate vying for preference based on clinical efficacy, safety profile, and cost. AMIDATE holds a niche position due to its specific pharmacological profile—notably its cardiovascular stability, making it particularly suitable for high-risk surgical and ICU patients. The demand for such targeted anesthetics remains steady owing to the increasing volume of surgical procedures and critical care interventions worldwide.

Market Drivers

  1. Rising Surgical Procedures and Critical Care Needs

    The global increase in surgical interventions, especially in aging populations, amplifies demand for rapid-onset anesthetics like AMIDATE. Procedures that require hemodynamic stability and quick recovery profiles favor etomidate over other agents, especially in cardiac surgeries and trauma cases. The World Health Organization reports a 4-6% annual growth in surgeries, underpinning steady demand.

  2. Preference for Hemodynamically Stable Anesthetics

    Etomidate is distinguished by minimal effects on cardiac output and blood pressure, rendering it indispensable for critically ill patients. This niche enhances its market stability, particularly amid concerns about hypotension associated with other anesthetics. As ICU populations expand globally, so does the necessity for such agents.

  3. Regulatory Approvals and Off-Label Uses

    Continued regulatory approvals for new indications and formulations—such as targeted sedation protocols—expand the drug's clinical utility. Additionally, research into off-label applications, including procedural sedation outside of anesthesia, sustains its relevance.

  4. Technological and Formulation Innovations

    Advances that improve drug stability, ease of administration, and safety profiles bolster AMIDATE’s market presence. Companies investing in enhanced delivery systems or biosimilars could influence market dynamics further.

Market Challenges

  1. Competition from Alternative Agents

    Propofol dominates the intravenous anesthetic segment due to its broad applicability and cost-effectiveness. While etomidate’s hemodynamic benefits give it an edge in select cases, widespread preference for cheaper, well-established agents limits growth potential.

  2. Adverse Effect Profile and Safety Concerns

    The risk of adrenal suppression with repeated doses or prolonged use constrains its application to specific scenarios. Concerns over nausea and vomiting, although manageable, also influence clinician choice toward alternatives.

  3. Regulatory and Patent Landscape

    Patent expirations and generic proliferation diminish pricing power and profit margins. Regulatory hurdles, particularly regarding safety warnings and label updates, can impact market penetration and sales strategies.

  4. Emerging Technologies

    Novel anesthetic modalities such as inhaled agents and non-injectable sedatives threaten to reduce reliance on traditional intravenous drugs like AMIDATE.

Financial Trajectory

The financial outlook for AMIDATE is shaped by sales volume, pricing strategies, competitive positioning, and macroeconomic factors influencing healthcare spending.

  • Historical Revenue Trends

    Historically, AMIDATE reported modest but steady revenues driven by its clinical niche. The integrative effect of regulatory approvals, hospital purchasing patterns, and clinician familiarity maintains its revenue base despite intense competition. However, patent expirationulent trends and generic availability have exerted downward pressure on pricing.

  • Forecasted Growth Patterns

    Market analysts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years for etomidate-based products, driven by increasing surgical volumes in emerging markets and continued ICU admissions. However, growth may plateau or decline if clinicians shift further towards alternative sedatives.

  • Pricing and Market Share

    The introduction of biosimilars or generic formulations would likely lead to price erosion but could expand volume sales if affordability widens market access, especially in low-to-middle-income countries. Premium positioning in high-acuity settings sustains higher price points but with limited margins compared to the broader anesthetic market.

  • Strategic Opportunities

    Collaborations with hospital networks, targeted marketing emphasizing safety profiles, and diversification into combination formulations could mitigate revenue risks and improve financial performance. Investing in research for novel delivery systems or indications may unlock new revenue streams.

Regulatory and Market Evolution

The future of AMIDATE depends significantly on regulatory environments and clinical guideline updates. As more data on adrenal suppression risks emerge, safety warnings may restrict formulary placement, affecting sales. Conversely, approvals for pediatric use or off-label sedation protocols could present growth opportunities.

Conclusion

AMIDATE’s market dynamics are characterized by its specialized clinical role, balancing steady demand among high-risk patient populations against intensifying competition and regulatory challenges. Its financial trajectory depends on strategic positioning, innovation, and regional market development. In the evolving landscape of anesthetic pharmacology, AMIDATE maintains relevance by leveraging its unique safety profile, although its growth potential remains cautiously optimistic in the broader context of medical advances.


Key Takeaways

  • Niche Positioning: Etomidate's hemodynamic stability sustains its importance in critical care and high-risk surgeries.
  • Market Challenges: Competition from propofol and generics, safety concerns, and regulatory shifts constrain growth.
  • Growth Opportunities: Emerging markets, off-label indications, and formulation innovations may expand market share.
  • Financial Outlook: Expected modest growth contingent on volume increases, strategic marketing, and regulatory landscape stability.
  • Strategic Focus: Enhancing safety profiles, clinical advocacy, and diversification can boost long-term profitability.

FAQs

  1. What differentiates AMIDATE from other intravenous anesthetics?
    Its key feature is minimal cardiovascular impact, making it ideal for unstable or high-risk patients where maintaining blood pressure and cardiac output are critical.

  2. Are there significant safety concerns with AMIDATE?
    The primary concern is transient adrenal suppression, especially with repeated doses or prolonged use. This influences prescribing in certain patient groups.

  3. How does market competition affect AMIDATE’s sales?
    Dominance of agents like propofol and the availability of generics suppress pricing and market share, although etomidate retains a niche in specific high-risk procedures.

  4. Can emerging therapies threaten AMIDATE’s market?
    Yes. Advances in inhaled anesthetics and non-injectable sedatives could reduce reliance on intravenous agents, impacting long-term sales.

  5. What are the future growth prospects for AMIDATE?
    Stabilized in high-acuity settings, future growth hinges on regional market expansion, new indications, and formulation innovations rather than broad market expansion.


Sources

  1. World Health Organization. Global Surgery Data. 2022.
  2. MarketWatch. Global Anesthetic Drugs Market Report. 2022.
  3. U.S. Food and Drug Administration. Drug Approval and Safety Data for Etomidate. 2021.
  4. Pharmacology and Therapeutics Journal. Comparative Safety Profiles of Intravenous Anesthetics. 2022.
  5. GlobalData. Future Trends in Anesthetic Market. 2023.

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