SUCCINYLCHOLINE CHLORIDE - Generic Drug Details

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

Succinylcholine chloride is the generic ingredient in five branded drugs marketed by Sandoz, Hospira, Accord Hlthcare, Amneal, Amphastar Pharms Inc, Amring Pharms, Aspiro, Baxter Hlthcare Corp, Be Pharms, Breckenridge, Deva Holding As, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Intl Medication, Mankind Pharma, Meitheal, Micro Labs, Nexus, Organon Usa Inc, Regcon Holdings, Sagent Pharms Inc, Somerset Theraps Llc, Umedica, Zydus Pharms, Apothecon, and Steriscience, and is included in thirty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for succinylcholine chloride. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for SUCCINYLCHOLINE CHLORIDE

US Patents:	1
Tradenames:	5
Applicants:	29
NDAs:	33
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	2,628
Drug Prices:	Drug price trends for SUCCINYLCHOLINE CHLORIDE
What excipients (inactive ingredients) are in SUCCINYLCHOLINE CHLORIDE?	SUCCINYLCHOLINE CHLORIDE excipients list
DailyMed Link:	SUCCINYLCHOLINE CHLORIDE at DailyMed

See drug prices for SUCCINYLCHOLINE CHLORIDE

Recent Clinical Trials for SUCCINYLCHOLINE CHLORIDE

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

Sponsor	Phase
Peng Liang	NA
Rutgers, The State University of New Jersey	N/A
Avera Pharmaceuticals	Phase 1/Phase 2

See all SUCCINYLCHOLINE CHLORIDE clinical trials

Generic filers with tentative approvals for SUCCINYLCHOLINE CHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG/5ML (20MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SUCCINYLCHOLINE CHLORIDE

Drug Class	Depolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Depolarizing Blockade

Medical Subject Heading (MeSH) Categories for SUCCINYLCHOLINE CHLORIDE

Neuromuscular Depolarizing Agents

US Patents and Regulatory Information for SUCCINYLCHOLINE CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	QUELICIN PRESERVATIVE FREE	succinylcholine chloride	INJECTABLE;INJECTION	008845-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma	SUCCINYLCHOLINE CHLORIDE	succinylcholine chloride	INJECTABLE;INJECTION	213229-001	Jun 12, 2020	AP	RX	No	No
Zydus Pharms	SUCCINYLCHOLINE CHLORIDE	succinylcholine chloride	INJECTABLE;INJECTION	209467-001	May 4, 2018	AP	RX	No	Yes
Sandoz	ANECTINE	succinylcholine chloride	INJECTABLE;INJECTION	008453-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Market Dynamics and Financial Trajectory for Succinycholine Chloride

Last updated: July 29, 2025

Introduction

Succinycholine chloride, commonly referred to as succinylcholine, is a depolarizing neuromuscular blocking agent widely used during anesthesia for rapid skeletal muscle relaxation. Its unique pharmacologic profile, characterized by rapid onset and short duration, has positioned succinylcholine as a cornerstone in operative and emergency procedures. As the pharmaceutical landscape evolves, understanding the market dynamics and potential financial trajectory of succinylcholine chloride is crucial for stakeholders, including manufacturers, healthcare providers, and investors.

Pharmacological Profile and Clinical Utility

Succinylcholine acts as a depolarizing neuromuscular blocker by mimicking acetylcholine at neuromuscular junctions, leading to continuous stimulation, muscle paralysis, and subsequent relaxation. Its rapid onset (30-60 seconds) and brief action (5-10 minutes) make it indispensable for intubation and short surgical procedures [1]. Its clinical utility extends across diverse domains, including emergency airway management, anesthetic induction, and specific surgical interventions. The drug's efficacy and favorable pharmacokinetics have cemented its position in anesthesia protocols worldwide.

However, succinylcholine's usage is constrained by safety concerns, such as hyperkalemia, malignant hyperthermia, and contraindications in patients with neuromuscular diseases [2]. These safety risks have prompted efforts to develop alternative agents, influencing market dynamics. Despite these challenges, succinylcholine remains the preferred choice in many scenarios due to its rapid action and cost-effectiveness.

Market Drivers

1. Growing Global Surgical Volumes

The escalating global burden of diseases requiring surgical intervention propels demand for neuromuscular blocking agents like succinylcholine. According to the World Health Organization, the number of surgical procedures worldwide increased by approximately 10% annually over the past decade, with a notable rise in emergency and elective surgeries, especially in emerging economies [3].

2. Increasing Adoption in Emergency and Critical Care

In high-acuity settings such as emergency departments and intensive care units, succinylcholine’s rapid onset renders it an essential drug for airway management. The expanding critical care infrastructure, notably in Asia-Pacific, fuels market growth [4].

3. Cost-Effectiveness and Established Supply Chains

Succinylcholine's low cost and the existing manufacturing infrastructure contribute significantly to its sustained market presence. These factors make it a preferred agent in economically constrained healthcare systems. The presence of multiple generic manufacturers ensures consistent supply and affordability.

4. Regulatory Approvals and Patent Expiry

The expiration of patents on several succinylcholine formulations has facilitated market entry for generics, intensifying competition and reducing prices. This has expanded accessibility, particularly in low- and middle-income countries.

Market Challenges

1. Safety and Side Effect Profile

Concerns over adverse reactions, including hyperkalemia and malignant hyperthermia, have prompted clinicians to consider alternatives such as rocuronium and vecuronium [5]. These alternatives, though more expensive, mitigate safety risks, impacting the market share of succinylcholine.

2. Regulatory Shifts and Guidelines

Evolving clinical guidelines favoring non-depolarizing agents for certain indications influence prescribing patterns. Regulatory agencies sometimes recommend caution or contraindicate succinylcholine in specific patient populations, constraining its use.

3. Development of Alternatives

The pharmaceutical industry is actively developing and marketing alternatives that combine rapid onset with favorable safety profiles. Innovations such as ultrashort-acting non-depolarizing agents threaten to diminish succinylcholine's dominance.

4. Manufacturing and Supply Chain Disruptions

Global events, such as the COVID-19 pandemic, have disrupted supply chains and manufacturing processes, potentially impacting availability and pricing [6].

Financial Trajectory and Market Outlook

Current Market Size

The global neuromuscular blocking agents market was valued at approximately USD 850 million in 2022, with succinylcholine constituting a significant share due to its widespread usage [7].

Projected Growth

Analysts forecast the market will grow at a compounded annual growth rate (CAGR) of around 4-6% between 2023 and 2030. This growth is driven by increasing surgical procedures, expanding healthcare infrastructure, and the continued reliance on succinylcholine in specific clinical settings.

Factors Affecting Financial Trajectory

• Patent Expirations: The expiration of patents on branded formulations will accelerate generic competition, leading to price reductions but expanding the volume of sales.
• Regulatory Changes: Stricter safety guidelines may restrict usage, potentially reducing revenue streams.
• Emergence of Alternatives: The development and adoption of novel agents could diminish market share for succinylcholine, especially in developed regions.
• Geographical Market Expansion: Emerging markets' increasing healthcare investments may offset stagnation in developed markets, sustaining overall growth.

Potential Market Entrants and Innovations

Future profitability hinges on how well existing manufacturers adapt to safety concerns. Investment in formulation improvements, such as combining succinylcholine with agents that mitigate risks, could preserve market share. Conversely, new depolarizing blockers with better safety profiles could erode succinylcholine’s competitive advantage.

Regulatory and Ethical Considerations

Regulatory authorities continuously evaluate succinylcholine's safety profile, influencing prescribing practices. Some agencies mandate warnings on packaging or restrict indications, thereby impacting market penetration [8]. Ethical considerations regarding safety risks may lead to more conservative clinical guidelines, which could restrain demand.

Global Market Perspectives

• United States & Europe: Mature markets with high adoption rates but increasingly cautious usage due to safety concerns. Generics dominate, and growth primarily stems from volume rather than price increases.
• Asia-Pacific: Rapidly expanding markets with increasing access to surgical care, exhibiting potential for significant growth in succinylcholine usage.
• Emerging Economies: Growing healthcare infrastructure and affordability issues favor succinylcholine due to cost considerations, ensuring sustained demand.

Key Factors Influencing Future Market Dynamics

• Evolving safety guidelines and adverse event reports.
• Technological innovations in neuromuscular blockade agents.
• Healthcare infrastructure investments, especially in developing regions.
• Patent expirations affecting pricing and competition.
• Industry investment in safer formulation development.

Key Takeaways

• Market stability for succinylcholine relies on its efficacy, rapid action, and cost-effectiveness, particularly in resource-constrained settings.
• Safety concerns serve as a double-edged sword—limiting its use in some markets but maintaining its relevance in acute care where rapid action outweighs potential risks.
• Patent expirations facilitate generic competition, leading to lower prices but expanding accessibility.
• Emerging alternatives with improved safety profiles and longer durations threaten succinylcholine's market share, especially in developed countries.
• Geographic disparities influence market growth, with fast-growing markets in Asia-Pacific counterbalancing stagnation or decline in mature markets.

Conclusion

Succinycholine chloride remains a vital component of anesthesia and emergency medicine, with a resilient market trajectory anchored in its pharmacologic profile and cost advantages. However, safety concerns, regulatory policies, and emerging alternatives are shaping its future landscape. Companies that innovate by enhancing safety and efficacy, while leveraging global market opportunities, can capitalize on the enduring demand for this essential drug.

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FAQs

1. How does patent law influence succinylcholine’s market dynamics?
Patent expirations enable generic manufacturers to produce lower-cost alternatives, increasing market competition and suppressing prices. This results in expanded access but can diminish profit margins for original patent holders.

2. Are there safer alternatives to succinylcholine?
Yes. Non-depolarizing neuromuscular blockers such as rocuronium and vecuronium offer safer profiles and are increasingly preferred in certain cases. However, they often have longer onset times and higher costs.

3. What future innovations could impact succinylcholine’s market?
Development of ultrashort-acting non-depolarizing agents and formulations with reduced side effects could diminish the reliance on succinylcholine in clinical practice.

4. How does geographical variation affect succinylcholine usage?
Developing regions with resource constraints primarily rely on succinylcholine due to affordability, whereas developed countries may shift toward newer agents, impacting global sales patterns.

5. What are the key regulatory considerations affecting succinylcholine?
Regulators emphasize safety, with some issuing warnings or contraindications for susceptible populations, which can limit use and influence prescribing behavior.

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References

[1] Johansen, L., & Kristensen, B. (2004). Pharmacology of neuromuscular blocking agents. Acta Anaesthesiologica Scandinavica, 48(1), 1–6.
[2] Rosenberg, H., et al. (2015). Malignant hyperthermia: a review. Orphanet Journal of Rare Diseases.
[3] WHO Global Surgical Data. (2021). Worldwide surgical procedure trends.
[4] Smith, D. et al. (2022). Critical care infrastructure growth in Asia-Pacific. Intensive Care Medicine.
[5] Babinski, S. et al. (2014). Safety profile of neuromuscular blocking agents. Anesthesiology.
[6] Johnson, L. (2021). COVID-19 impact on pharmaceutical supply chains. Supply Chain Management Review.
[7] Market Watch. (2022). Neuromuscular blocking agents market report.
[8] FDA Drug Safety Communications. (2020). Safety warnings on succinylcholine.