Last Updated: April 30, 2026

DROPERIDOL - Generic Drug Details


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What are the generic drug sources for droperidol and what is the scope of freedom to operate?

Droperidol is the generic ingredient in four branded drugs marketed by Abraxis Pharm, Am Regent, Astrazeneca, Hikma, Hospira, Igi Labs Inc, Luitpold, Smith And Nephew, Solopak, Watson Labs, Rising, and Epic Pharma Llc, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for droperidol. Two suppliers are listed for this compound.

Summary for DROPERIDOL
US Patents:0
Tradenames:4
Applicants:12
NDAs:24
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 46
Patent Applications: 7,136
What excipients (inactive ingredients) are in DROPERIDOL?DROPERIDOL excipients list
DailyMed Link:DROPERIDOL at DailyMed
Recent Clinical Trials for DROPERIDOL

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

SponsorPhase
Stanford UniversityEARLY_PHASE1
Universitas PadjadjaranPHASE2
University of ThessalyPHASE4

See all DROPERIDOL clinical trials

Pharmacology for DROPERIDOL
Medical Subject Heading (MeSH) Categories for DROPERIDOL
Anatomical Therapeutic Chemical (ATC) Classes for DROPERIDOL

US Patents and Regulatory Information for DROPERIDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 071982-001 May 4, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072028-001 Apr 13, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira DROPERIDOL droperidol INJECTABLE;INJECTION 072272-001 Aug 31, 1995 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira DROPERIDOL droperidol INJECTABLE;INJECTION 071645-001 Apr 7, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astrazeneca DROPERIDOL droperidol INJECTABLE;INJECTION 072018-001 Oct 20, 1988 DISCN 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

Droperidol: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is droperidol’s market position?

Droperidol is a generic, off-patent antiemetic and antipsychotic (butyrophenone) with use cases tied to anesthesia and acute nausea/vomiting. Commercial dynamics are driven by (1) hospital formulary adoption, (2) competitive pressure from other perioperative antiemetics and sedatives, and (3) country-by-country regulatory and reimbursement rules for injectable products.

Key structural traits shape its market:

  • Prescription, hospital-led demand: Usage concentrates in perioperative care, emergency settings, and surgical anesthesia workflows.
  • Generic economics dominate: Post-patent life reduces pricing power and increases procurement intensity (tenders, contracting, substitution).
  • Safety and labeling affect uptake: Regulatory focus on QT prolongation and dose/monitoring protocols influences prescribing behavior, especially where hospitals require ECG monitoring for certain patient classes.
  • Short purchasing cycles: Hospitals buy based on clinical protocols, drug shortages dynamics, and budget cycles rather than long product lifetimes.

How does the competitive set influence pricing and volume?

Droperidol competes primarily in perioperative antiemetic and sedation workflows. The effective competitive set includes:

  • Other antiemetics: 5-HT3 antagonists (ondansetron), NK1 antagonists (aprepitant, in some settings), dexamethasone-based regimens.
  • Sedatives and anesthesia adjuncts: Agents used for anxiolysis, behavioral control, and peri-procedural sedation.
  • Regional availability and formulary position: In many jurisdictions, generics of multiple classes increase substitution and procurement leverage.

The result is a market where droperidol’s share is less about unique innovation and more about:

  • Procurement price vs. protocol fit
  • Regulatory acceptance for the targeted route (primarily injectable)
  • Hospital standardization around pathways for nausea/vomiting prevention and treatment

What revenue trajectory do market mechanics imply for droperidol?

With no active exclusivity regime, droperidol’s financial trajectory is typically characterized by:

  • Early growth phases after reformulation or labeling expansion (when hospitals expand use under protocol)
  • Mid-stage stabilization as formularies mature
  • Long-run price erosion as additional generic entrants raise supply and intensify tender competition
  • Demand volatility during supply disruptions (common for older sterile injectables), which can temporarily lift pricing and volume

This pattern is consistent with a mature, off-patent pharmaceutical niche where revenue is driven more by supply continuity and contract pricing than by brand differentiation.

How do regulatory and safety constraints change demand?

Droperidol’s prescribing is shaped by QT-related warnings and monitoring expectations. Across markets, these create dosing and patient selection protocols that can narrow routine use, especially for outpatient or low-acuity settings.

Net impact on market dynamics:

  • Higher administrative burden in some hospitals (ECG monitoring, risk screening) can slow adoption.
  • Protocolization helps sustain usage in centers that have established pathways.
  • Tendering may favor cost-effective generics that also meet packaging, sterility, and supply reliability standards.

What financial drivers matter most for manufacturers and wholesalers?

For a generic sterile injectable like droperidol, financial performance depends on operational and commercial variables more than novel R&D economics:

  1. Sterile manufacturing capacity and batch reliability
    • Sterile injectables are sensitive to batch failures and supply chain disruptions.
  2. Contract penetration in hospital systems
    • Revenue follows inclusion in group purchasing organization (GPO) or regional procurement contracts.
  3. Working capital tied to inventory turns
    • Low-turn hospital supply chains can still require ready inventory to avoid stockouts.
  4. Regulatory maintenance costs
    • Ongoing compliance supports market continuity but does not create growth.

What is the likely demand outlook by use context?

Demand concentrates in:

  • Perioperative care (prevention and treatment of postoperative nausea and vomiting in specific protocols)
  • Emergency and acute care settings where nausea control and behavioral indications overlap with clinician preference
  • Adjunct use where anesthesia teams standardize on specific antiemetic regimens

In off-patent status markets, volume growth typically tracks:

  • Growth in surgical/anesthesia procedure volumes
  • Shifts in clinical pathways that continue to include droperidol despite safety monitoring constraints
  • Replacement of unavailable products during temporary shortages in some regions

Is droperidol’s market predominantly price-competitive?

Yes. For off-patent drugs, price competition generally sets the baseline. In practice:

  • Brand premium collapses after patent expiry.
  • Manufacturer differentiation shifts to packaging format, availability, shelf-life, and tender competitiveness.
  • Gross margin pressure is common as procurement spreads across multiple suppliers.

A price-led environment can still support stable revenue for established suppliers if they maintain:

  • Consistent supply
  • Contract leadership in at least one major purchasing network
  • Documentation readiness for pharmacovigilance and regulatory updates

What does the patent and exclusivity structure mean for financial trajectory?

Droperidol’s commercialization is largely shaped by the post-exclusivity reality for older molecules:

  • No meaningful late-stage pipeline dependency
  • No sustained premium pricing
  • Revenue resilience comes from procurement inclusion rather than innovation

In this regime, financial trajectory is typically defined by:

  • Market share drift among generics
  • Procurement price compression
  • Localized shifts due to regulatory or supply events

How does procurement tendering translate into quarter-to-quarter revenue dynamics?

Hospital contracting creates discrete step-changes:

  • When droperidol is added to a formulary, volume can step up across affected facilities.
  • When a competing generic wins a tender, unit pricing drops and volumes may shift quickly.
  • When shortages occur in sterile injectables, available suppliers can experience short-term revenue lift but risk downstream contract renegotiation.

For investors or strategists, this means financial trajectories are often:

  • Lumpy around tender cycles
  • Sensitive to supply disruptions
  • Bounded by clinical protocol adoption rates

Where can upside come from, given off-patent status?

Upside for droperidol is usually operational rather than scientific:

  • Expanded contract coverage across hospital networks
  • Improved supply reliability that sustains preferred supplier status
  • Stable or improved pack formats that fit hospital substitution systems
  • Protocol reinforcement where clinical pathways keep droperidol in standard nausea control regimens

Key benchmarks to model droperidol financial trajectory

A practical modeling framework for droperidol’s business case uses:

  • Estimated addressable market size: surgeries and acute care antiemetic demand requiring injectable options
  • Formulary penetration rate: percent of target hospitals using droperidol
  • Unit economics: net price after tender rebates and distribution discounts
  • Supply factor: active supplier count and regional availability
  • Risk-adjusted continuity: likelihood of sterile manufacturing disruption

Because the drug is mature, small changes in net price and contract share often dominate long-run revenue outcomes.

What is the net effect on revenue growth and margins?

Typical outcomes for mature generics like droperidol:

  • Revenue growth: low-to-moderate, with periods of step-change tied to formulary and tender events
  • Margins: pressured by price competition; improved reliability and contracting can stabilize EBITDA
  • Capex intensity: moderate, tied to maintaining sterile manufacturing and quality systems rather than scaling innovation platforms

What should market participants watch next?

For droperidol specifically, monitor:

  • Regulatory labeling updates impacting QT monitoring requirements and dosing protocols
  • Tender outcomes in major hospital systems and GPO contract cycles
  • Supply stability for injectable sterile products
  • Shifts in antiemetic practice patterns (for example, increased preference for competing regimens in certain surgical specialties)

These items drive the near-term financial path more than demand creation through clinical innovation.


Key Takeaways

  • Droperidol is a mature, off-patent injectable where demand is hospital-protocol driven and competition is largely price-led.
  • Financial trajectory is shaped by procurement contracting and supply reliability, not premium pricing or innovation-led growth.
  • Safety-related QT monitoring protocols influence adoption and patient selection, which can cap growth in some settings but supports stable use where protocols are standardized.
  • Revenue is typically lumpy around formulary and tender cycles, with margin compression risk from generic pricing competition.

FAQs

1) Is droperidol a branded-growth story or a procurement-driven generic?

It is procurement-driven. Net revenue hinges on tender inclusion, supply continuity, and net pricing after contracting rather than brand premium.

2) What most directly changes droperidol unit demand in hospitals?

Formulary updates, perioperative antiemetic pathway changes, and tender awards that alter which supplier supplies the contract.

3) Why does droperidol’s QT-related labeling matter financially?

It can reduce prescribing in lower-resource or outpatient contexts by increasing monitoring requirements, which lowers the addressable usage rate unless hospital protocols already manage QT risk.

4) Does increased generic competition increase total market size or mainly reduce prices?

Typically it mainly reduces prices and shifts market share among suppliers, because clinical indications and prescribing protocols often cap overall usage growth.

5) Where can a manufacturer protect margins for an older sterile injectable?

By maintaining supply reliability, achieving preferred supplier status in tenders, optimizing batch yield and compliance costs, and minimizing stockout-related loss of contract position.


References

[1] FDA. Droperidol prescribing information and safety information (QT prolongation/monitoring related communications). U.S. Food and Drug Administration. (Accessed via FDA labeling archives).
[2] European Medicines Agency (EMA). Assessment and product information for droperidol-containing medicines (QT and risk management related documentation). European Medicines Agency.
[3] World Health Organization (WHO). WHO Model List of Essential Medicines: injectable antiemetics and related perioperative supportive care categories (context for mature supportive therapies). World Health Organization.

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