Last Updated: September 24, 2026

NIMBEX PRESERVATIVE FREE Drug Patent Profile


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When do Nimbex Preservative Free patents expire, and when can generic versions of Nimbex Preservative Free launch?

Nimbex Preservative Free is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in NIMBEX PRESERVATIVE FREE is cisatracurium besylate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nimbex Preservative Free

A generic version of NIMBEX PRESERVATIVE FREE was approved as cisatracurium besylate by SANDOZ INC on February 3rd, 2012.

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Summary for NIMBEX PRESERVATIVE FREE
Paragraph IV (Patent) Challenges for NIMBEX PRESERVATIVE FREE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NIMBEX PRESERVATIVE FREE Injection cisatracurium besylate 2 mg/mL, 10 mL vial 020551 1 2009-08-12
NIMBEX PRESERVATIVE FREE Injection cisatracurium besylate 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial 020551 1 2009-08-04

US Patents and Regulatory Information for NIMBEX PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-003 Dec 15, 1995 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-002 Dec 15, 1995 DISCN Yes 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 NIMBEX PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-003 Dec 15, 1995 4,179,507 ⤷  Start Trial
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-002 Dec 15, 1995 5,453,510 ⤷  Start Trial
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-002 Dec 15, 1995 4,179,507 ⤷  Start Trial
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-003 Dec 15, 1995 5,453,510 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Last updated: July 30, 2026

Nimbex Preservative Free (cisatracurium) has limited direct “brand versus generic” upside because its US market is structurally constrained by hospital contracting, low per-treatment drug cost, and tight formulary controls for neuromuscular blockers. Financial trajectory depends on (1) US hospital utilization of cisatracurium versus rocuronium/vecuronium, (2) pricing and contract renewals for preservative-free supply, (3) biosupply and manufacturing continuity, and (4) whether FDA labeling and sourcing changes drive share shifts.

Market dynamics and financial trajectory are therefore less about exclusive IP and more about contract wins, product availability, and substitution risk inside the perioperative and ICU neuromuscular blockade segment.

What is NIMBEX Preservative Free (cisatracurium) and how does the US market size typically evolve?

NIMBEX Preservative Free is the preservative-free presentation of cisatracurium, a long-acting neuromuscular blocking agent used for surgical anesthesia and ICU ventilator synchrony. Market demand is tied to procedures requiring neuromuscular blockade: major surgery case volume, anesthetic practice patterns, and ICU patient-days.

Primary demand drivers

  • Perioperative throughput: volume of surgeries under general anesthesia where neuromuscular blockade is used.
  • ICU sedation and ventilation: frequency of neuromuscular blockade for ventilator synchrony and to facilitate airway management.
  • Practice substitution: conversion between neuromuscular blockers based on onset profile, duration, and reversal workflows.
  • Supply continuity: hospital switching risk rises when specific SKUs or concentrations face shortages or manufacturing constraints.

Typical market evolution mechanics

  • Share movement is contract-driven: hospital group purchasing organizations (GPOs) and IDNs (integrated delivery networks) rebalance formularies on contracting cycles and clinical committee decisions.
  • Price tends to compress over time in highly procurable hospital drugs, particularly when multiple alternatives are available and procurement is competitive.

How does NIMBEX Preservative Free compete against rocuronium and vecuronium in hospital formularies?

Cisatracurium competes primarily against aminosteroid and other neuromuscular blockers. Competitive outcomes in US hospitals depend on clinical endpoints and procurement terms, not patent duration.

Key competitive levers

  • Reversal pathway fit: cisatracurium’s clinical handling versus alternatives during reversal with acetylcholinesterase inhibitors and selective sugammadex workflows (for aminosteroids).
  • Patient population targeting: renal/hepatic considerations influence choice for some ICUs and complex cases.
  • Workflow and anesthesia practice standardization: anesthesiology groups often standardize around a small set of agents and rotate formulations.

Substitution dynamics

  • In many hospitals, formulary consolidation favors fewer SKUs to reduce stock complexity.
  • If preservative-free cisatracurium is not the contracted default, switching to an alternative can be rapid, especially when clinical committees view differences as manageable.

Why does “preservative free” matter for market performance?

The preservative-free attribute affects purchasing decisions and safety workflows in certain clinical settings.

Where preservative-free presentations gain traction

  • Institutional policies: some hospitals prefer preservative-free injectables for certain lines, compounding rules, or patient safety standards.
  • High-acuity use cases: neonatal/pediatric-adjacent protocols and ICU line management can increase demand for preservative-free options.
  • Drug preparation and stability practices: nursing and pharmacy standard operating procedures can bias demand toward preservative-free products.

Commercial consequence

  • Preservative-free can reduce substitution resistance if it is embedded in hospital protocol and procurement specs.
  • That protection is fragile if hospitals have contracted alternatives that meet the same “preservative free” requirement.

What are the main revenue and margin pressure points for NIMBEX Preservative Free?

Revenue for neuromuscular blockers is exposed to procurement and substitution, while margins are pressured by supply chain and pricing.

Common margin pressure sources

  • Contract price resets: GPO and IDN contracts compress unit price over time.
  • Mix shift: movement between concentrations and presentation formats impacts realized pricing.
  • Supply risk costs: manufacturing disruptions can require premium logistics and inventory holding, lowering gross margin.
  • Indexing to competitor pricing: buyers benchmark against alternative neuromuscular blockers.

Financial trajectory implications

  • Net revenue can remain stable while unit margin declines if volume holds but pricing resets.
  • In a competitive hospital environment, “brand premium” is often capped by tender outcomes.

When do NIMBEX Preservative Free exclusivity protections stop affecting competitive entry risk?

For hospitals, exclusivity typically affects entry timing and labeling permission, but the financial story is still shaped by whether alternatives are already available at scale.

Commercial interpretation of exclusivity

  • If multiple cisatracurium presentations and/or other neuromuscular blockers have been in the market for years, exclusivity may have limited marginal impact after the initial competitive window.
  • Any remaining differentiation usually comes from presentation requirements (preservative free, concentration), supply reliability, and contracting.

What generic entry risks exist for NIMBEX Preservative Free?

Generic risk in injectables is driven by:

  • Whether the preservative-free format is required in contracts/specs
  • Whether generic manufacturers maintain bioavailability equivalence and acceptable quality systems
  • Whether supply is reliable during launch ramp

Generic exposure pattern

  • In many hospital injectables, competitors can gain share quickly once they clear regulatory and supply thresholds.
  • The main barrier to share loss is contract lock-in and protocol entrenchment around preservative-free products.

What FDA regulatory status milestones affect market access for NIMBEX Preservative Free?

Market access is influenced by:

  • FDA approval and label maintenance
  • Changes to manufacturing sites
  • Supplements affecting formulation, container-closure, or preservatives
  • Ongoing compliance that affects lot release and supply continuity

Financial effects show up as:

  • sudden changes in sell-in when supply is constrained
  • changes in realized ASP when contract renegotiations incorporate competitor pricing

How does procurement contracting typically shape NIMBEX Preservative Free financial trajectory?

Contracting effects

  • GPO/IDN contract wins increase volume and stabilize demand.
  • Loss of contracted status can reduce volume quickly because hospitals have low tolerance for non-formulary items.
  • SKU rationalization can favor the contracted concentration/presentation. If preservative-free is not the contracted spec, demand declines even if the active ingredient remains “therapeutically interchangeable.”

Practical market outcome

  • The financial trajectory often tracks contract cycles and availability events rather than smooth organic growth.

What manufacturing and supply dynamics can move quarterly performance for NIMBEX Preservative Free?

Neuromuscular blockers face demand spikes tied to scheduling and surgery volume, while supply constraints can create:

  • backorders and deferred cases
  • substitution to alternatives
  • downstream stocking behavior that alters next-quarter demand

Supply-continuity impacts

  • Shortages drive immediate share loss that may not fully revert after supply normalizes.
  • Normalized supply can still leave permanent formulary friction if clinicians and pharmacists establish replacement workflows.

Which competitors have the highest likelihood of share capture from NIMBEX Preservative Free?

Share capture typically comes from two fronts:

  1. Same-class competition from other cisatracurium products that meet hospital preservative-free specs.
  2. Cross-class substitution to rocuronium or vecuronium when reversal workflows and institutional preferences support it.

Commercially relevant competitor set

  • Neuromuscular blockers widely stocked by GPOs and used in standard anesthesia protocols.
  • Brands and authorized generics that can supply at scale and price aggressively.

What is the likely financial trajectory scenario set for NIMBEX Preservative Free over the next 3–5 years?

Scenario 1: Contract retention + stable supply

  • Volume remains steady due to preservative-free protocol adherence.
  • Realized price drifts down through periodic renegotiations.
  • Net revenue stays supported while margins gradually compress.

Scenario 2: Protocol-spec loss or competitive tender

  • Volume drops as hospitals shift to cheaper contracted alternatives.
  • Even if the active ingredient remains available, preservative-free specs reduce substitution options.
  • Financial trajectory shows step-down in sell-in.

Scenario 3: Supply disruption

  • Immediate volume loss from inability to fill orders.
  • Substitution becomes operationalized by anesthesia and pharmacy teams.
  • Potential permanent share erosion.

How strong is the patent estate relevance to NIMBEX Preservative Free market economics?

For hospital injectables, patents often play a secondary role in long-term economics once pharmacologically equivalent products exist. The practical determinants are:

  • availability of alternative cisatracurium SKUs that meet preservative-free requirements
  • ability to contract competitively
  • manufacturing continuity

If multiple competitors can supply therapeutically equivalent neuromuscular blockade, patent protection does not prevent pricing pressure.

Key takeaways

  • NIMBEX Preservative Free’s market dynamics are primarily driven by hospital contracting, preservative-free protocol specifications, substitution to other neuromuscular blockers, and supply continuity.
  • Financial trajectory typically reflects contract and tender cycles and realized pricing compression more than patent-driven exclusivity.
  • The largest downside risks are non-contracted status and supply disruption, both of which can create durable share loss.
  • Upside is constrained by the competitive nature of perioperative neuromuscular blockade procurement and the limited room for premium pricing.

FAQs

1) How does preservative-free format affect substitutability for neuromuscular blockers in US hospitals?
Preservative-free specs reduce substitution flexibility when contracts explicitly require preservative-free presentations; if alternatives are not contracted to meet that spec, share loss can slow.

2) What procurement levers most influence NIMBEX Preservative Free unit volume?
GPO/IDN contract status, tender outcome terms, and SKU rationalization within hospital pharmacy formularies.

3) What drives quarterly swings in neuromuscular blocker injectables?
Surgery scheduling volatility, ICU patient-day shifts, and manufacturing or lot-release disruptions that affect fill rates.

4) How do cross-class substitutions (cisatracurium to rocuronium/vecuronium) impact revenue?
They can reduce demand quickly if anesthesiology and pharmacy committees accept alternatives and if those alternatives are contracted at better pricing.

5) Does exclusivity meaningfully protect hospital injectable revenue after multiple alternatives exist?
Often not; once alternatives are available and supply is reliable, pricing and contract pressure dominate revenue trajectory.

References

  1. No sources were provided in the prompt, and no external dataset was supplied to ground financial trajectory and market sizing for NIMBEX PRESERVATIVE FREE.

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