CISATRACURIUM BESYLATE - Generic Drug Details

What are the generic drug sources for cisatracurium besylate and what is the scope of patent protection?

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.

There are nine drug master file entries for cisatracurium besylate. Fourteen suppliers are listed for this compound.

Summary for CISATRACURIUM BESYLATE

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	27
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	13
Patent Applications:	714
Drug Prices:	Drug price trends for CISATRACURIUM BESYLATE
What excipients (inactive ingredients) are in CISATRACURIUM BESYLATE?	CISATRACURIUM BESYLATE excipients list
DailyMed Link:	CISATRACURIUM BESYLATE at DailyMed

See drug prices for CISATRACURIUM BESYLATE

Recent Clinical Trials for CISATRACURIUM BESYLATE

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

Sponsor	Phase
Watim Medical & Dental College	NA
Yichang Humanwell Pharmaceutical Co.,Ltd	Phase 4
Second Affiliated Hospital of Nanchang University	Phase 4

See all CISATRACURIUM BESYLATE clinical trials

Pharmacology for CISATRACURIUM BESYLATE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for CISATRACURIUM BESYLATE

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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
Hikma	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203078-002	Dec 18, 2023	AP	RX	No	No
Hospira	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203238-001	Mar 30, 2018	AP	RX	No	No
Sagent Pharms Inc	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	201836-002	Nov 6, 2020	AP	RX	No	No
Hikma	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203078-001	Jun 28, 2022	AP	RX	No	No

Expired US Patents for CISATRACURIUM BESYLATE

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

Market Dynamics and Financial Trajectory for Cisatracurium Besylate

Last updated: July 27, 2025

Introduction

Cisatracurium besylate, a non-depolarizing neuromuscular blocking agent, plays a pivotal role in anesthesia practice, primarily facilitating endotracheal intubation and muscle relaxation during surgery. Its unique pharmacologic profile, pharmacokinetics, and safety profile distinguish it from other neuromuscular blockers, positioning it as a preferred choice in various clinical settings. Analyzing its market dynamics and financial trajectory involves understanding its manufacturing landscape, competitive environment, regulatory status, and evolving demand within healthcare systems globally.

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Pharmacological Profile and Clinical Significance

Cisatracurium besylate is part of the benzylisoquinolinium class, characterized by its intermediate duration of action and organ-independent metabolism via Hofmann elimination. These features confer a safety advantage, reducing complications related to renal or hepatic impairment, thereby expanding its application across diverse patient populations [1].

Its efficacy, coupled with a favorable side-effect profile—minimal cardiovascular effects and low histamine release—has contributed to its widespread adoption in anesthetic protocols. The drug is available in both hospital and outpatient settings, underpinning a steady demand.

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Market Drivers

Increasing Global Surgical Procedures

Rising global surgical volumes, driven by aging populations and expanding healthcare infrastructure, underpin demand for neuromuscular blocking agents like cisatracurium besylate. In 2021, an estimated 312 million surgeries globally were performed, with elective and emergency surgeries contributing significantly [2]. This trend supports the consistent need for muscle relaxants with reliable pharmacodynamics.

Advancements in Anesthesia Technology

Innovations in anesthesia monitoring and safety protocols favor drugs with predictable profiles, making cisatracurium’s organ-independent metabolism attractive. The integration of neuromuscular monitoring enhances precision, further bolstering its usage.

Regulatory Approvals and Patents

Patent expirations and regulatory approvals influence market access and pricing. While Hospira's brand (Nimbex) held patents, generic versions have entered the market post-expiry, intensifying competition and reducing costs.

Growing Adoption in Critical Care

Beyond operative settings, cisatracurium’s role in intensive care units (ICUs) for ventilator management amid respiratory crises (e.g., COVID-19) has amplified its utility, creating additional revenue streams [3].

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Market Challenges

Competitive Landscape

Generic manufacturing has increased, leading to aggressive pricing strategies. Competing agents such as rocuronium and vecuronium provide alternatives, especially when cost is a primary concern, diminishing market margins for cisatracurium.

Price Sensitivity and Cost Constraints

Healthcare systems with budget limitations may favor less expensive alternatives, limiting market potential in low- and middle-income regions.

Regulatory and Reimbursement Factors

Differing regulatory standards across regions influence drug approval and reimbursement policies. Market access is further affected by national formulary preferences and procurement policies.

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Manufacturing and Supply Chain Dynamics

Major pharmaceutical companies like Pfizer (via its acquisition of Hospira), Baxter, and Teva dominate cisatracurium manufacturing. Manufacturing complexities, such as the synthesis process and maintaining stringent quality controls, influence production costs and pricing strategies.

Supply chain disruptions—exacerbated by global events such as the COVID-19 pandemic—have impacted procurement and delivery, prompting suppliers to diversify sourcing and increase inventory buffers, affecting pricing and availability.

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Regional Market Outlook

North America

The U.S. and Canada comprise mature markets with high surgical volumes and sophisticated healthcare infrastructure. The adoption of neuromuscular blocking agents is well-established, with a trend toward generic use driving pricing pressure. Greater emphasis on patient safety and monitoring supports cisatracurium’s ongoing relevance.

Europe

European countries exhibit high adoption rates, with regulatory frameworks facilitating accelerated approvals for biosimilars and generics. Cost containment strategies and national formularies influence procurement.

Asia-Pacific

Mirroring global trends, Asia-Pacific presents an expanding market owing to increasing surgical procedures, healthcare investment, and rising anesthesia needs. The presence of multiple generic manufacturers heightens competitiveness but also offers significant growth potential due to lower current penetration rates in some countries.

Latin America and Middle East & Africa

Emerging markets offer considerable growth opportunities due to expanding healthcare infrastructures. However, market entry is challenged by variable regulatory landscapes and pricing sensitivities.

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Financial Trajectory and Future Market Estimates

The global neuromuscular blocking agents market was valued at approximately USD 1.3 billion in 2021, with projections indicating a compound annual growth rate (CAGR) of around 4-6% over the next five years [4]. Cisatracurium’s share within this market remains robust, buoyed by its favorable safety profile and organ-independent metabolism.

Generics account for over 70% of the market share, exerting downward pressure on prices. Companies investing in biosimilar development and expanding production capacity could influence future pricing and market distribution. Additionally, innovations in anesthesia monitoring technology and preferences for shorter-acting agents could impact the demand trajectory.

The ongoing global health crises have underscored the importance of neuromuscular blocking agents in critical care, supporting sustained or increased usage. Moreover, policy shifts toward value-based care emphasize safety and efficacy, potentially enhancing cisatracurium's appeal.

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Regulatory and Patent Landscape

Patent expirations globally have permitted generic manufacturers to produce cost-effective versions, stimulating price competition and volume growth. Regions such as North America and Europe have well-established regulatory pathways for approval, whereas emerging markets may face delays or less stringent regulatory environments.

Ongoing patent litigations and patent expirations will continue to shape the competitive landscape, influencing both supply and pricing dynamics.

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Conclusion

Cisatracurium besylate’s market remains characterized by steady demand driven by rising global surgical volumes and its favorable pharmacokinetics. Competitive pressures, generic availability, and cost considerations remain primary market influencers. Strategic positioning by manufacturers—focusing on quality, supply chain resilience, and technological integration—is essential for capturing growth opportunities.

In the context of evolving healthcare paradigms emphasizing safety, efficiency, and cost-effectiveness, cisatracurium besylate is poised for sustained relevance, especially in high-resource settings, with emerging markets presenting substantial future growth potential. The drug’s financial trajectory will be shaped by innovation, regulatory developments, and economic factors influencing healthcare expenditure.

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Key Takeaways

• Steady Demand: Global increase in surgical procedures sustains consistent need for neuromuscular blocking agents like cisatracurium.
• Competitive Dynamics: The proliferation of generics post-patent expiry intensifies price competition, impacting margins.
• Regional Variability: Developed markets favor high-quality, organ-independent agents; emerging markets offer growth prospects due to expanding healthcare infrastructure.
• Critical Care Expansion: The COVID-19 pandemic and respiratory crises have expanded cisatracurium’s application in ICU settings.
• Future Outlook: Continuous innovations, regulatory landscapes, and supply chain resilience will determine the drug's financial trajectory.

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FAQs

1. What are the main factors driving demand for cisatracurium besylate?
   Increased global surgical volumes, healthcare infrastructure development, and its safety profile support ongoing demand.

2. How does patent expiration affect the market for cisatracurium?
   Patent expirations lead to the entry of generic competitors, reducing prices and increasing market volume but exerting pressure on profit margins for brand-name manufacturers.

3. What regional markets offer the most growth opportunities for cisatracurium?
   The Asia-Pacific region and emerging markets in Latin America and Africa present significant growth potential due to expanding healthcare access and infrastructure.

4. What challenges does cisatracurium face in the competitive landscape?
   Competition from other neuromuscular blockers, price sensitivity in cost-conscious healthcare systems, and regulatory hurdles complicate market expansion.

5. How might future healthcare trends influence cisatracurium’s market?
   Adoption of advanced anesthesia monitoring, emphasis on safety protocols, and innovations in alternative agents could reshape demand patterns.

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Sources

[1] Brull, S.J., et al. (2019). Pharmacology of neuromuscular blocking agents. Anesthesiology.
[2] World Health Organization. (2021). Surgical Care and Outcomes Data.
[3] Eysenbach, G. (2020). Critical care neuromuscular blockade and COVID-19. Critical Care.
[4] Markets and Markets. (2022). Neuromuscular Blocking Agents Market by Type, End User, Region – Global Forecast to 2027.