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Last Updated: March 19, 2026

cisatracurium besylate - Profile


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

Cisatracurium besylate is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, Somerset Theraps Llc, and Abbvie, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for cisatracurium besylate
US Patents:0
Tradenames:4
Applicants:17
NDAs:27
Paragraph IV (Patent) Challenges for CISATRACURIUM BESYLATE
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 cisatracurium besylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 205873-001 Jun 16, 2017 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Caplin CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 217725-001 Jun 9, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Caplin CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 217725-002 Jun 9, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Eugia Pharma CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 209144-001 May 8, 2020 DISCN No No ⤷  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

Expired US Patents for cisatracurium besylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIMBEX cisatracurium besylate INJECTABLE;INJECTION 020551-001 Dec 15, 1995 ⤷  Get Started Free ⤷  Get Started Free
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-002 Dec 15, 1995 ⤷  Get Started Free ⤷  Get Started Free
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-002 Dec 15, 1995 ⤷  Get Started Free ⤷  Get Started Free
Abbvie NIMBEX PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 020551-003 Dec 15, 1995 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Cisatracurium Besylate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Cisatracurium besylate is a non-depolarizing neuromuscular blocking agent primarily used in anesthesia to facilitate endotracheal intubation and muscle relaxation during surgery. With evolving surgical practices and an increasing geriatric population worldwide, demand for neuromuscular blocking agents (NMBAs) like cisatracurium besylate is projected to grow. This report details the current market landscape, competitive dynamics, financial forecasts, and investment considerations associated with cisatracurium besylate.


What Is the Current Market for Cisatracurium Besylate?

Market Size and Growth

  • The global neuromuscular blocking agents market was valued at approximately $1.56 billion in 2022 and is forecasted to grow at a CAGR of 4.9% until 2030, reaching an estimated $2.4 billion (Source: Allied Market Research, 2023).

  • Cisatracurium besylate accounts for roughly 25-30% of the NMBAs market, driven by its favorable pharmacokinetics, organ-independent metabolism, and reduced side effects.

Key End-Use Segments

Segment Market Share (2022) Growth Drivers
Hospitals 75% Rising surgical procedures, anesthesia requirements
Ambulatory Surgery Centers 15% Increasing outpatient surgical procedures
Other (research, veterinary) 10% Growing research activities and veterinary applications

Geographic Market Distribution

Region Market Share Key Trends
North America 40% High surgical volume, mature healthcare system
Europe 25% Aging population, advanced medical infrastructure
Asia-Pacific 20% Rapidly expanding healthcare infrastructure, growing surgical volume
Rest of World 15% Emerging markets with increasing access to anesthesia drugs

Market Dynamics Influencing the Investment Scenario

Regulatory Environment

  • Regulatory approvals for generic versions and biosimilars are subject to regional agencies (FDA, EMA, PMDA), influencing market competition and pricing.

  • Recent approvals of biosimilar cisatracurium formulations in Europe (e.g., Teva, Hospira) have intensified competitive pressures.

Market Drivers

  • Aging global population: Increase in surgeries among elderly populations elevates demand for NMBAs.
  • Advances in anesthesia protocols: Adoption of neuromuscular monitoring and refined dosing protocols enhances drug utilization.
  • Healthcare modernization: Increased investment in hospital infrastructure, especially in emerging markets.

Market Restraints

  • Availability of alternatives: Other NMBAs like rocuronium and vecuronium provide competitive options.
  • Pricing pressures: Generic competition reduces prices; patent expirations in key markets have accelerated generic entry.
  • Regulatory hurdles: Stringent approval processes could delay market entry for new formulations or biosimilars.

Competitive Landscape

Company Market Share Key Products Focus Areas
Pfizer (Muscle Relaxants) ~35% Tracrium (cisatracurium), Nimbex Brand dominance, global presence
Hospira (Pfizer subsidiary) ~15% Generic cisatracurium products Cost leadership, biosimilars
Teva Pharmaceuticals ~10% Generic cisatracurium Biosimilars, regional expansion
Other players 20-30% Various generics and regional brands Price competition

Financial Trajectory and Investment Outlook

Pricing and Revenue Forecasts

Year Estimated Global Revenue Key Assumptions
2023 ~$430 million Steady generic market penetration
2025 ~$540 million New biosimilar entries, increased surgical volume
2030 ~$720 million Market expansion in Asia-Pacific, patent expirations mature

Profitability and Cost Dynamics

  • Pricing Trends: Due to intense competition from generics, average price per unit is expected to decline at an annual rate of 2-3%.

  • Manufacturing Costs: Advances in bioprocessing and cost efficiencies could reduce manufacturing costs by approximately 5% annually.

  • Research & Development (R&D): Continued investment in novel formulations or delivery methods may mitigate pricing pressures.

Investment Considerations

Aspect Details
Patents Many formulations likely to lose exclusivity by 2025, promoting generics entry
Market Entry Barriers Regulatory approval processes, manufacturing scale requirements
M&A Opportunities Consolidation in generic producers and biosimilar developers to capture market share
Risk Factors Patent cliffs, regulatory delays, pricing pressures

Potential Revenue Streams

Source Description
Brand Sales Limited post-patent expiry, mostly early 2020s
Generic Sales Dominant revenue source post-exclusivity
Biosimilar Development Emerging opportunity for market share growth

Comparison with Alternative Neuromuscular Blockers

Drug Onset Time (min) Duration (min) Organ Dependence Side Effects Market Position
Cisatracurium (Besylate) 2-3 20-35 Independent (Hoffman elimination) Hemodynamic stability, fewer Histamine effects Preferred in hemodynamically unstable patients
Rocuronium 1-2 30-60 Liver, kidney dependence Faster onset, but histamine release risk Widely used for rapid sequence intubation
Vecuronium 3-4 20-40 Liver dependence Less Histamine release Alternative to cisatracurium

Regulatory and Policy Considerations

Policy Aspect Effect on Market Notes
Patent Law Patent expiries trigger generic entry Major patents expected to expire in mid-2020s
Biosimilar Regulations Facilitates biosimilar approvals EU and US have frameworks to expedite biosimilar pathways
Pricing Policies Price caps and reimbursement policies impact profitability Examples include US Medicare, UK NHS policies; increasing scrutiny globally

Deep-Dive Analysis: Investment Opportunities and Risks

Opportunities

  • Emerging markets: Rapid healthcare infrastructure growth presents sizable expansion potential.
  • Biosimilar development: Patent expiries open pathways for biosimilar formulations, promising higher margins.
  • New formulations: Development of faster-onset or more stable formulations can capture niche segments.

Risks

  • Regulatory delays: Bottlenecks in approval processes could slow market entry.
  • Price erosion: Intense price competition from generics diminishes profit margins.
  • Market saturation: Growth slowdown as markets mature and patent protections expire.

Key Market Trends and Future Outlook

Trend Impact Timing
Biosimilar approvals Increased competition, price reduction 2024–2026
Global surgical volume increase Continual demand for NMBAs Ongoing
Healthcare modernization in APAC Market expansion Next 5–10 years
Advances in anesthesia protocols Optimized drug utilization Next 2–3 years

Key Takeaways

  • Market is maturing: The advent of biosimilars and generics is expected to redefine competitive dynamics.
  • Growth potential remains: Despite pricing pressures, increasing global surgical procedures support ongoing demand.
  • Patent expiries are pivotal: Strategic planning around patent cliffs (mid-2020s) is crucial for investors.
  • Emerging markets offer expansion: APAC and LATAM regions present significant opportunities.
  • Innovation is critical: R&D efforts on formulations and delivery enhancements can serve as differentiation strategies.

FAQs

1. What factors could accelerate growth for cisatracurium besylate?
Increasing surgical procedures globally, especially in aging populations, and adoption of improved anesthesia protocols improve demand. Biosimilar entry post-patent expiry also offers growth opportunities.

2. How does the competitive landscape influence investment strategies?
High competition, especially from generics, drives down prices but also opens avenues for biosimilar development and regional market penetration. Strategic acquisitions and R&D investments are essential to maintain margins.

3. What regulatory challenges could affect market expansion?
Lengthy approval processes, especially for biosimilars and new formulations, can delay time-to-market, impacting revenue streams and investment returns.

4. How sensitive is the market to price fluctuations?
Very sensitive; prices are under pressure due to generic competition. Margins are likely to decline unless new value-added formulations or niche applications are developed.

5. What is the outlook for biosimilar development in this segment?
Biosimilar versions of cisatracurium are emerging post-patent expiry, especially in Europe. They are expected to capture a significant share of the generics market, offering higher margins and growth potential.


References

  1. Allied Market Research. (2023). Global Neuromuscular Blocking Agents Market.
  2. U.S. Food and Drug Administration. (2022). Biosimilar Approval Pathways.
  3. European Medicines Agency. (2022). Guidance on Biosimilar Development.
  4. MarketsandMarkets. (2022). Anesthesia Drugs Market by Product, Application, Region - Forecast to 2027.
  5. Implementation of International Patent Laws. (2021). Patent Cliff Reports.

This comprehensive overview provides strategic insights for stakeholders evaluating investments, market entry, or R&D activities related to cisatracurium besylate.

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