Last Updated: August 9, 2026

Vecuronium bromide - Generic Drug Details


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

Vecuronium bromide is the generic ingredient in two branded drugs marketed by Organon Usa Inc, Eugia Pharma, Gland, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharm, and Watson Labs, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for vecuronium bromide. Ten suppliers are listed for this compound.

Summary for vecuronium bromide
US Patents:0
Tradenames:2
Applicants:10
NDAs:13
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 10
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 15
Patent Applications: 2,974
What excipients (inactive ingredients) are in vecuronium bromide?vecuronium bromide excipients list
DailyMed Link:vecuronium bromide at DailyMed
Recent Clinical Trials for vecuronium bromide

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

SponsorPhase
Tamas Vegh, MDPHASE4
Shanxi Bethune HospitalNA
The Second Affiliated Hospital of Harbin Medical UniversityPhase 4

See all vecuronium bromide clinical trials

Pharmacology for vecuronium bromide
Medical Subject Heading (MeSH) Categories for vecuronium bromide

US Patents and Regulatory Information for vecuronium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 203725-002 Jul 30, 2019 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 075164-002 Oct 21, 1999 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 075218-002 Aug 23, 1999 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gland VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 205390-002 May 26, 2016 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-002 Apr 30, 1984 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 079001-001 Jun 17, 2009 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

Expired US Patents for vecuronium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-002 Apr 30, 1984 ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-002 Apr 30, 1984 ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-003 Jan 3, 1992 ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-003 Jan 3, 1992 ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-002 Apr 30, 1984 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Last updated: July 12, 2026

Vecuronium Bromide Market Dynamics and Financial Trajectory (Global Use, Pricing, and Exclusivity Risks)

Vecuronium bromide is a generic-led, low-margin neuromuscular blocking agent (NMBA) with limited patent-driven growth. Demand tracks surgical volume and anesthesia practice, while pricing pressure reflects multi-source competition and hospital procurement leverage. Financial trajectory is largely shaped by (1) entry timing of low-cost generics, (2) supply continuity and regulatory actions for sterile injectables, (3) tender-driven reimbursement and contracting in major hospital systems, and (4) any regional shortages that temporarily lift net price. Because the active is long off-patent in most jurisdictions, the near-to-medium term outlook depends more on manufacturing scale and cost than on product lifecycle innovations.


How does vecuronium bromide perform in hospital anesthesia markets and revenue mix?

Vecuronium bromide is used in perioperative anesthesia to induce and maintain neuromuscular blockade for intubation and surgical procedures, and it is commonly managed as a formulary commodity in hospital procurement. Typical commercial drivers:

  • Case volumes and mix: Elective and inpatient surgical throughput drive baseline utilization. Growth comes from procedure volume and aging populations rather than drug-specific substitution.
  • Formulary placement as a commodity: Hospitals often rationalize NMBA use through group purchasing organizations (GPOs) and multi-source bids.
  • Switching within NMBA class: Replacement risk exists versus other NMBAs (e.g., rocuronium, cisatracurium, atracurium), especially where clinicians prefer shorter or more predictable onset/reversal profiles or where institutional supply constraints dictate selection.
  • Reversal practices: Where sugammadex access and protocol adoption are high, rocuronium usage can gain share, shifting vecuronium demand even without safety-driven contraindications.

Financial profile (typical for generic sterile injectables):

  • High volume, lower net price after competitive tender cycles.
  • Net sales sensitivity to procurement contracts and package size standardization.
  • Manufacturing and sterile facility uptime are major determinants of realized revenue, not promotional spend.

What drives vecuronium bromide net pricing: tender cycles, supply constraints, or reimbursement?

Net pricing is predominantly procurement-driven. In hospital systems, vecuronium bromide is exposed to competitive bidding that compresses unit pricing over time once additional FDA-approved (or locally approved) sources establish supply. Key mechanisms:

  1. Bid-based contracting

    • Multi-year contracts and volume commitments reduce variability in unit volume but push pricing down.
    • Smaller vendors face margin squeeze and may exit unless they secure stable channel access.
  2. Shortage episodes and allocation

    • Sterile injectable supply disruptions can trigger temporary price increases and expedited purchasing.
    • Shortage duration matters for revenue. Prolonged allocation tends to lift average realized price but increases demand uncertainty and replacement once supply stabilizes.
  3. WAC-to-net compression

    • Even where list prices remain visible, realized revenue declines after distribution rebates, GPO discounts, and contract pricing.
  4. Regional reimbursement structure

    • Where hospital budgets are fixed or where tender outcomes determine effective reimbursements, price becomes a function of supplier competition more than clinical need.

When does vecuronium bromide face exclusivity cliffs or generic entry risks?

For vecuronium bromide, the main generic entry issue is not brand exclusivity but incremental multi-source entry and label/geographic availability that intensify tender competition.

Practical “exclusivity” drivers:

  • ANDA approvals and 505(b)(2) supplements that expand presentations (strengths, package sizes, or labeling changes).
  • Process and manufacturing site approvals that determine whether a product can reliably compete in hospitals.
  • Regulatory constraints impacting supply such as facility inspections, data integrity issues, sterility assurance, or container closure requirements.

Generic entry risk map (commercially relevant):

  • High risk of margin compression whenever a new supplier is cleared to commercialize at meaningful scale.
  • Lower realized risk when incumbents maintain procurement lock-in through contracts and supply reliability.

Because vecuronium bromide is already a mature generic commodity, the most material “entry” impacts come from new manufacturing capacity and new label expansions rather than patent expiry events.


What patents protect vecuronium bromide, and how strong is the patent estate?

Vecuronium bromide is primarily constrained by the fact pattern of early small-molecule API discovery and older formulation/process IP. For the purposes of current market dynamics, the actionable assessment is:

  • Likely weak remaining patent leverage in major jurisdictions for the core active ingredient and broad, established dosing forms.
  • Potential residual IP may exist in specific jurisdictions around:
    • particular formulation attributes (buffering system, pH targets, stabilizers),
    • manufacturing processes,
    • and specific labeled instructions or controlled-release concepts, though NMBA injectables typically do not support long-tail innovation in the mature generic stage.

In a commodity phase, the patent estate rarely governs realized revenue after multiple approved sources enter.

Business implication: competition is primarily driven by cost, supply, and contracting rather than by litigation-driven delay.


Is there ongoing vecuronium bromide patent litigation affecting generics or supply?

For mature generic NMBAs, litigation tends to be intermittent and less likely to govern market shares unless:

  • a dominant supplier is defending a late-arising formulation/process improvement,
  • or a challenger is using an abbreviated pathway requiring patent carve-outs or settlement terms.

In the absence of a currently active, widely documented litigation record for vecuronium bromide that delays approvals or launches, market outcomes are more directly linked to procurement and manufacturing capability than to Paragraph IV settlements.


What is the Orange Book status of vecuronium bromide in the US?

Orange Book status is typically used to track:

  • listed patents (drug substance, drug product, method of use),
  • expiration dates,
  • and whether a generic applicant filed Paragraph IV certifications.

Commercially actionable read-across: when Orange Book lists are minimal and multiple ANDA entries are already established, the market is in a late lifecycle where pricing pressure dominates and where entry timing is driven by facility readiness and inspection outcomes rather than listed patent sunsets.


How do vecuronium bromide vs rocuronium vs cisatracurium compare in market share and pricing pressure?

Vecuronium faces structural competition across two dimensions: clinical practice preference and economic procurement.

  • Rocuronium (and sugammadex ecosystem):

    • In facilities with broad sugammadex availability, rocuronium can be favored for reversal flexibility.
    • Procurement contracts may shift NMBA selections toward whichever drug has the best total cost of anesthesia reversal workflow.
  • Cisatracurium and atracurium (organ-independent metabolism considerations):

    • Where clinicians prioritize Hofmann elimination and organ impairment profiles, cisatracurium/atracurium can take share, reducing vecuronium usage.
  • Procurement realities:

    • Even if clinical preference exists, tender decisions drive purchasing. A supplier with lower net price or stronger supply continuity can win.

Result: vecuronium’s financial trajectory is often flat-to-declining in net price terms even if procedural volume rises.


What formulations and dosing presentations matter for market access and contracting?

For NMBA injectables, procurement hinges on:

  • Strength and presentation matched to anesthesia workflows,
  • package size and handling convenience,
  • labeling alignment with local protocols,
  • availability and shelf stability for hospital pharmacies.

Commercial impact:

  • A supplier that can offer the “right” vial size at competitive net price can outcompete without any clinical differentiation.
  • Shortfalls in one presentation can cause temporary substitution, shifting usage to competing NMBAs until supply returns.

What regulatory factors most affect vecuronium bromide supply and financial outcomes?

For sterile injectables, the main regulatory and operational factors are:

  • Facility inspections and quality systems
    • Sterility assurance, aseptic processing controls, and data integrity.
  • Container closure and particulate standards
    • Compliance influences batch disposition and time to release.
  • Labeling changes and manufacturing site updates
    • Post-approval changes can delay commercialization or reduce near-term supply.
  • Drug shortage status
    • Allocation policies influence average realizations and can create downstream substitution stickiness.

When supply is stable, revenue tracks utilization. When supply breaks, revenue can spike short term but often drops afterward as clinicians lock in alternate agents.


How do international market dynamics differ for vecuronium bromide (EU, UK, emerging markets)?

EU/UK:

  • Hospital tender systems, centralized purchasing in many regions, and multi-source availability typically compress pricing.
  • Product availability varies by national approvals and manufacturing site capacity.

Emerging markets:

  • Competition often arrives later than in the US/EU.
  • Price sensitivity is higher, and supply continuity can be more variable.
  • Regulatory approval pathways and local GMP alignment can delay entries, supporting temporary price resilience until multiple sources appear.

Net effect: the global financial trajectory is usually “stair-step declines” in unit price as additional suppliers enter, punctuated by short-term rebounds during supply constraints.


What is the financial outlook: volume growth vs margin erosion for vecuronium bromide?

The financial trajectory is typically characterized by:

  • Volume: stable or modestly growing with surgical volume and NMBA usage rates.
  • Gross margin: pressured by:
    • low list-to-net pricing,
    • manufacturing cost leverage requirements (sterile production is expensive),
    • and competition for contract wins.
  • Operating leverage: limited because marketing and distribution costs don’t scale as efficiently as commodity unit prices.

Investment-style implication: winners are manufacturers that deliver:

  • reliable sterile production,
  • faster batch release,
  • and competitive contract pricing without quality disruptions.

Key timelines and “what to watch” for the next 12-36 months

Because the drug is in a mature generic phase, the key monitors are operational and regulatory rather than IP expiration:

  1. Procurement tender calendars in major hospital systems

    • These determine step changes in net price and volume.
  2. Shortage or discontinuation signals

    • Look for supply warnings that precede allocation and price changes.
  3. ANDA/approval and manufacturing site readiness

    • New approvals can trigger immediate bid competition.
  4. Regulatory enforcement actions

    • Any aseptic processing, sterility, or data integrity events can remove supply quickly.
  5. Shifts in reversal practice adoption

    • Expanding sugammadex use can structurally reduce demand for certain NMBAs.

Key Takeaways

  • Vecuronium bromide is a mature, generic-led anesthesia commodity where net revenue is driven by hospital procurement and supply continuity, not by patent-led differentiation.
  • The financial trajectory usually shows stable utilization but margin compression as multi-source competition intensifies and tender outcomes drive pricing.
  • The biggest upside/downside events are manufacturing and regulatory supply shocks, not exclusivity cliffs or Paragraph IV-driven delays.
  • Competitive displacement risk comes from other NMBAs and from institutional protocols tied to reversal strategy.

FAQs

Will vecuronium bromide pricing improve during drug shortages?

Shortages can lift realized net price temporarily through allocation-driven purchasing, but post-supply normalization often triggers substitution and restores competitive pricing pressure.

Which hospital contracts most influence vecuronium bromide revenue?

Large GPO-driven tenders and national or regional group purchasing contracts determine unit pricing and volume allocations more than brand list prices.

Does sugammadex adoption materially reduce vecuronium bromide demand?

It can reduce NMBA share where clinicians prefer rocuronium and reversal workflow protocols incorporate sugammadex, shifting formulary preferences.

Are new vials/strengths more important than IP for vecuronium bromide market share?

Yes. In commodity NMBAs, product presentation alignment, reliability, and contract pricing often outweigh incremental labeling or formulation differences.

What operational factors most affect profitability for vecuronium bromide manufacturers?

Sterile manufacturing uptime, batch release timeliness, facility inspection outcomes, and cost efficiency in producing low-margin injectable units.


References

  1. FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations (Vecuronium bromide). (FDA).
  2. FDA Drug Shortages. Neuromuscular blocking agents and injectable antineoplastic shortage notices as applicable. (FDA).
  3. FDA. ANDA Approval and Regulatory Information. (FDA).

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