AMIDATE Drug Patent Profile

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 4^th, 1996.

Summary for AMIDATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	5
Patent Applications:	5,929
Drug Prices:	Drug price information for AMIDATE
What excipients (inactive ingredients) are in AMIDATE?	AMIDATE excipients list
DailyMed Link:	AMIDATE at DailyMed

See drug prices for AMIDATE

Recent Clinical Trials for AMIDATE

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

Sponsor	Phase
New Hanover Regional Medical Center	Phase 4
South East Area Health Education Center, Wilmington, NC	Phase 4
University of California, Davis	Phase 4

See all AMIDATE clinical trials

Pharmacology for AMIDATE

Drug Class	General Anesthetic
Physiological Effect	General 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

AMIDATE Market Dynamics, Patent Position, Competition, and Financial Trajectory

Last updated: August 7, 2026

AMIDATE is the former U.S. brand for etomidate injection, an intravenous general anesthetic used for induction of anesthesia. Its commercial position is now determined by generic etomidate suppliers, hospital procurement, manufacturing reliability, and clinical substitution rather than brand pricing or patent exclusivity. No public AMIDATE-specific revenue series is available. The product has no meaningful remaining U.S. patent moat, no biosimilar exposure, and limited standalone financial visibility.

What is AMIDATE and who manufactures it?

AMIDATE is etomidate injection, typically supplied at a concentration of 2 mg/mL. Etomidate is an imidazole-derived intravenous anesthetic with rapid onset and relatively limited cardiovascular depression compared with several alternatives.

Product attribute	Publicly reported position
Brand	AMIDATE
Active ingredient	Etomidate
Dosage form	Intravenous injection
Typical concentration	2 mg/mL
Therapeutic category	General anesthetic
Primary use	Induction of general anesthesia
U.S. brand owner history	Hospira and predecessor companies
Current commercial model	Generic etomidate injection
Biologic status	Small-molecule drug; biosimilar rules do not apply
Primary buyers	Hospitals, ambulatory surgery centers, emergency departments, anesthesia providers

Hospira became part of Pfizer in 2015. Pfizer’s acquisition expanded its hospital injectable portfolio, but AMIDATE does not have the commercial profile of Pfizer’s major branded medicines. Public Pfizer filings do not report AMIDATE revenue as a separate product line.[1]

Etomidate is also used in emergency airway management and rapid-sequence intubation. Its use is constrained by concern over transient adrenal suppression, particularly after repeated dosing or continuous exposure. This clinical issue affects demand and creates substitution opportunities for propofol, ketamine, and other induction agents.[2]

What is the FDA regulatory status of AMIDATE?

AMIDATE is an established injectable anesthetic, not a recently approved molecular entity. The historical product was marketed under a New Drug Application for etomidate injection. Current U.S. availability is primarily associated with generic abbreviated new drug applications rather than a differentiated branded product.

FDA status and dosage form

The relevant product characteristics are:

• Route of administration: intravenous.
• Strength: generally 2 mg/mL.
• Indication: induction of general anesthesia.
• Prescription status: prescription-only hospital drug.
• Regulatory pathway for competitors: ANDA approval for generic etomidate injection.
• Clinical setting: operating rooms, emergency departments, intensive-care settings, and procedural areas.

The FDA labeling identifies etomidate as an induction agent and warns about adrenal cortical suppression, pain on injection, myoclonus, nausea, vomiting, and rare serious hypersensitivity reactions.[3]

The product is not a biologic. Biosimilar competition is therefore not relevant. Competitive entry occurs through generic injectable approvals, procurement contracts, and supply availability.

When did AMIDATE lose exclusivity?

AMIDATE’s meaningful U.S. market exclusivity expired many years ago. Etomidate was introduced decades ago, and generic versions have competed in the U.S. market for an extended period.

Exclusivity category	AMIDATE position
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current commercial significance
Reference-product exclusivity	Expired
Patent-based brand protection	No commercially relevant current protection identified
Generic competition	Established
Biosimilar competition	Not applicable

The commercial consequence is direct: a new generic does not need to overcome a branded AMIDATE franchise. It competes against existing generic manufacturers and hospital contracts.

What patents protect AMIDATE and etomidate injection?

No active U.S. patent estate appears to protect the core etomidate molecule or the conventional 2 mg/mL injectable product in a manner that would block ordinary generic entry.

Patent position

Patent category	Commercial assessment
Core compound patent	Expired
Basic injectable formulation patent	No current blocking position identified
Method-of-use patent	No material current barrier identified
Device or delivery patent	Not central to the conventional vial product
Manufacturing-process patent	May exist historically, but does not protect ordinary generic supply broadly
Orange Book strategy	No meaningful current patent-based exclusivity
Litigation value	Low relative to newer branded injectable products

The main intellectual-property barriers are therefore operational rather than legal. Manufacturers must maintain sterile manufacturing capability, validated aseptic processes, quality systems, regulatory compliance, and reliable access to active pharmaceutical ingredient. These barriers can limit the number of effective suppliers even when patent protection is absent.

Does AMIDATE have Orange Book-listed patents?

The conventional AMIDATE product does not have a commercially important Orange Book patent position that would delay generic entry. Any historic listing associated with the reference product would be too old to support current branded exclusivity.

For generic competition, the relevant regulatory issue is approval of an ANDA and compliance with applicable labeling, manufacturing, stability, and injectable-drug requirements. A Paragraph IV challenge is not a meaningful current event for AMIDATE because the principal commercial opportunity is not to invalidate a live blocking patent.

Are there Paragraph IV challenges to AMIDATE?

No material current Paragraph IV litigation is associated with AMIDATE’s core product. Paragraph IV certifications are most consequential when a branded reference product has unexpired Orange Book patents. AMIDATE is in the opposite position: its principal market has already transitioned to generic competition.

A new entrant could still face regulatory or commercial obstacles, including:

• FDA deficiency letters or delayed approval.
• Manufacturing-site inspection findings.
• Sterility or particulate-control failures.
• Active ingredient supply disruptions.
• Hospital formulary exclusion.
• Contracting pressure from incumbent generic suppliers.
• Product liability exposure related to administration errors or adverse reactions.

These risks can affect launch economics without creating patent-based entry delay.

How large is the etomidate and AMIDATE market?

The market is a small, mature hospital injectable segment. Public sources do not disclose a reliable, AMIDATE-specific annual revenue figure. Market-research estimates for global etomidate sales vary by inclusion of hospital tenders, generic products, geographies, and related anesthesia formulations. Those estimates should not be treated as reported AMIDATE revenue.

The economic profile has four characteristics:

1. Low unit value. Etomidate injection is a generic hospital product, not a high-priced specialty medicine.
2. Contract-driven purchasing. Group purchasing organizations, hospital systems, and wholesalers exert substantial price pressure.
3. Low brand loyalty. Buyers generally prioritize availability, approved labeling, price, and supply reliability.
4. Shortage sensitivity. A temporary manufacturing interruption can shift significant volume to remaining suppliers.

The product can be clinically important while remaining financially modest. Its value to a manufacturer depends on portfolio scale, manufacturing utilization, and the ability to bundle it with other hospital injectables.

What is the financial trajectory for AMIDATE?

AMIDATE’s standalone financial trajectory is best characterized as mature, declining as a brand, and stabilized at the generic category level.

Period	Financial interpretation
Original branded period	Higher price and greater product differentiation
Generic-entry period	Price compression and share fragmentation
Mature generic period	Low unit pricing, recurring hospital demand
Current position	Limited brand revenue; value concentrated in supply contracts and portfolio economics

Pfizer does not report AMIDATE as a separate revenue-generating asset in its public financial disclosures.[1] The absence of a disclosed product line means analysts cannot calculate audited brand revenue, gross margin, or year-over-year sales from Pfizer’s annual reports.

For a generic supplier, the financial model is more likely to depend on:

• Annual vial volume.
• Contract award rates.
• Net price after wholesaler and group-purchasing discounts.
• Manufacturing yield.
• Fill-finish capacity utilization.
• Cost of active ingredient and packaging.
• Recall and shortage risk.
• Portfolio cross-selling.

Etomidate may have strategic value as part of a hospital injectable portfolio even when its direct revenue is limited. A supplier with existing sterile fill-finish capacity can operate the product at lower incremental cost than a new entrant.

Which drugs compete with AMIDATE?

AMIDATE competes with both other etomidate products and alternative induction agents.

Competitor	Competitive position
Generic etomidate injection	Direct substitute; primary competitive set
Propofol	Widely used induction agent; faster recovery but greater cardiovascular and respiratory depression
Ketamine	Useful when analgesia or sympathetic stimulation is desirable
Methohexital	Barbiturate alternative used in selected anesthesia settings
Thiopental	Limited availability in some markets; historical alternative
Midazolam	Sedative with slower and less predictable induction characteristics

Etomidate’s principal clinical advantage is relative hemodynamic stability during induction. Its principal disadvantage is adrenal suppression, along with myoclonus and injection-site discomfort. Clinical selection depends on patient condition, anesthesia protocol, procedure type, emergency setting, and institutional preference.[2][3]

How does AMIDATE compare with propofol?

Etomidate generally has stronger positioning in patients where maintaining blood pressure during induction is important. Propofol has broader routine operating-room use and is often favored for rapid recovery and familiarity.

Factor	Etomidate	Propofol
Hemodynamic stability	Generally favorable	More hypotension risk
Recovery profile	Rapid	Rapid
Adrenal suppression	Recognized concern	Not the defining concern
Injection pain	Common concern	Common concern
Generic competition	Extensive	Extensive
Price position	Low-cost generic	Low-cost generic
Hospital demand	Protocol and patient-selection driven	Broad routine use

This is not a single-winner market. Propofol remains the broader routine anesthetic, while etomidate retains a defensive niche in hemodynamically fragile patients and emergency induction protocols.

What formulation and manufacturing barriers affect AMIDATE?

The conventional product is a sterile injectable. Manufacturing complexity is higher than for an ordinary oral generic.

Formulation considerations

The commercial product must control:

• Sterility assurance.
• Particulate matter.
• Container closure integrity.
• Assay and degradation products.
• pH and solution stability.
• Compatibility with administration equipment.
• Packaging and vial performance.
• Labeling for intravenous use.

Hospitals may also consider preservative content, vial sizes, supply continuity, and compatibility with local medication protocols. Product differentiation is limited unless a supplier offers a meaningful packaging, concentration, or administration advantage that receives FDA approval and hospital acceptance.

Manufacturing barriers

The key barrier is sterile manufacturing capacity. FDA records have repeatedly identified injectable-drug quality and supply issues as market-wide risks, including facility shutdowns, remediation, inspection findings, and component shortages.[4]

For etomidate, the strongest practical barrier is not a blocking patent. It is the cost and regulatory burden of operating an approved sterile facility at acceptable quality and volume.

What litigation and settlement agreements affect AMIDATE?

No material current patent litigation or settlement agreement is associated with the core AMIDATE product. The product’s litigation profile is more likely to involve ordinary product liability, manufacturing quality, procurement disputes, or hospital-use issues than Paragraph IV patent litigation.

No branded-generic settlement has strategic relevance comparable with settlements involving protected medicines with multiple years of remaining patent life. Generic entry is already established, and the main commercial question is supplier economics rather than launch timing after a litigation agreement.

What generic launch scenarios exist for AMIDATE?

Base-case scenario

Existing generic suppliers retain the majority of demand. Prices remain compressed, and supply contracts determine share. Revenue growth is limited to market expansion, shortage-related volume, or portfolio cross-selling.

Upside scenario

A supplier enters after a competitor experiences a manufacturing interruption. Temporary price improvement and higher volume follow, but the advantage is likely to attract additional supply and erode over time.

Downside scenario

Demand shifts toward propofol or ketamine because of institutional protocols, concerns over adrenal suppression, or changes in emergency medicine practice. A manufacturer also may exit if contract prices do not cover sterile production costs.

Strategic-acquisition scenario

A hospital injectable company acquires or licenses a product portfolio that includes etomidate. The value would derive from manufacturing capacity and product breadth, not AMIDATE’s standalone brand equity.

How geographically broad is AMIDATE protection?

There is no meaningful current global patent perimeter around conventional etomidate injection. Market access depends on country-specific registrations, local generic approvals, procurement systems, and manufacturing compliance.

Geography	Commercial position
United States	Mature generic hospital market
European Union	Generic etomidate access varies by national authorization and procurement
Canada	Generic injectable competition
Emerging markets	Access depends on local registration, tenders, and supply reliability
Global patent exposure	Limited for the old core molecule

A company assessing international expansion should focus on registration status, local tender pricing, import requirements, pharmacovigilance, and sterile supply capacity.

How strong is the AMIDATE patent estate?

AMIDATE has a weak patent estate but a persistent clinical niche.

Dimension	Assessment
Patent strength	Low
Regulatory exclusivity	Expired
Brand power	Low
Clinical differentiation	Moderate in selected patients
Generic threat	High and established
Supply-chain defensibility	Moderate
Revenue growth potential	Low
Portfolio value	Potentially useful for hospital injectable suppliers

The product can remain commercially relevant without patent protection because anesthesia providers continue to need multiple induction options. That clinical demand does not translate into strong pricing power.

Key Takeaways

• AMIDATE is the historic brand for etomidate injection, a mature intravenous anesthetic.
• Its U.S. commercial position is generic, not branded.
• No meaningful current patent or exclusivity barrier protects conventional etomidate injection.
• Paragraph IV litigation and patent settlements are not central to the product’s current market.
• Biosimilar competition does not apply because etomidate is a small-molecule drug.
• Public filings do not disclose AMIDATE-specific revenue or profit.
• Financial value is concentrated in hospital contracts, sterile manufacturing capacity, and supply reliability.
• Propofol is the broader routine competitor; ketamine and methohexital compete in selected settings.
• Etomidate retains clinical demand because of its relative hemodynamic stability, despite adrenal-suppression concerns.
• The main commercial risk is generic price compression and supplier substitution, while the main operational risk is sterile manufacturing disruption.

FAQs About AMIDATE

Is AMIDATE still sold under its original brand name?

The U.S. market is primarily supplied through generic etomidate injection. Historical brand references may remain in clinical records and product labeling, but current purchasing is generally generic-driven.

Does AMIDATE have a generic equivalent?

Yes. Etomidate injection is available from generic manufacturers in the same broad dosage form and concentration used for the original AMIDATE product.

Is etomidate more profitable than propofol?

There is no public product-level evidence showing that AMIDATE or generic etomidate has higher profitability than propofol. Both are mature injectable products subject to hospital contracting and price pressure.

Can a new company obtain exclusivity for an etomidate formulation?

A differentiated formulation could potentially receive patent or regulatory protection if it meets statutory requirements and produces a distinct approved product. Conventional etomidate injection does not have that protection.

Does etomidate face a risk of clinical replacement?

Yes. Propofol and ketamine can replace etomidate in selected protocols. Replacement risk is moderated by etomidate’s role in patients where cardiovascular stability is a priority.

References

1. Pfizer Inc. (2024). 2023 annual report. Pfizer Inc.

2. Miller, R. D., Cohen, N. H., Eriksson, L. I., Fleisher, L. A., Wiener-Kronish, J. P., & Young, W. L. (Eds.). (2020). Miller’s anesthesia (9th ed.). Elsevier.

3. U.S. Food and Drug Administration. (n.d.). Etomidate injection prescribing information. FDA.

4. U.S. Food and Drug Administration. (n.d.). Drug shortages: Injectable drug manufacturing and supply information. FDA.