Sugammadex sodium - Generic Drug Details

What are the generic drug sources for sugammadex sodium and what is the scope of patent protection?

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, B Braun Medical, and Zydus Pharms, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Sugammadex sodium has forty-two patent family members in thirty countries.

There are two drug master file entries for sugammadex sodium. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for sugammadex sodium

International Patents:	42
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	12
Patent Applications:	109
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sugammadex sodium
DailyMed Link:	sugammadex sodium at DailyMed

Recent Clinical Trials for sugammadex sodium

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

Sponsor	Phase
The Fourth Affiliated Hospital of Zhejiang University School of Medicine	NA
Hui Xu	NA
Korea University Ansan Hospital	Phase 4

See all sugammadex sodium clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM

Applicant	Application No.	Strength	Dosage Form
		500MG/5ML(100MG/ML)	INJECTABLE;INJECTION
		200MG/2ML(100MG/ML)	INJECTABLE;INJECTION

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 sugammadex sodium

Anatomical Therapeutic Chemical (ATC) Classes for sugammadex sodium

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRIDION	Injection	sugammadex sodium	200 mg/2 mL and 500 mg/5 mL	022225	14	2019-12-16

US Patents and Regulatory Information for sugammadex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214290-002	Oct 4, 2023		DISCN	No	No
Aspiro	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337-002	Jun 9, 2023	AP	RX	No	No
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	RE44733*PED				Y
Zydus Pharms	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214290-001	Oct 4, 2023		DISCN	No	No
Aspiro	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337-001	Jun 9, 2023	AP	RX	No	No

Expired US Patents for sugammadex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	6,949,527
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	6,949,527
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,009
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	7,265,099
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	7,265,009

International Patents for sugammadex sodium

Country	Patent Number	Title	Estimated Expiration
Czech Republic	298206	Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition)
Colombia	5251450	DERIVADOS DE 6-MERCAPTO-CICLODEXTRINA
Taiwan	I242015
Israel	149423
Peru	09022001

Supplementary Protection Certificates for sugammadex sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	340	Finland
1259550	91501	Luxembourg		91501, EXPIRES: 20230725
1259550	SZ 47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725

Market Dynamics and Financial Trajectory for Sugammadex Sodium

Last updated: December 3, 2025

Executive Summary

Sugammadex sodium, a pioneering reversal agent for aminosteroid neuromuscular blocking agents, has significantly impacted anesthesia practices globally since its approval. This analysis evaluates current market dynamics, competitive positioning, regulatory landscape, and financial forecasts, emphasizing growth drivers and challenges for stakeholders. With a projected compound annual growth rate (CAGR) exceeding 10% over the next five years, the drug's market trajectory is driven by advancements in surgical procedures, expanding adoption, and pipeline developments. However, factors such as pricing pressures, regulatory hurdles, and competition from alternative reversal agents pose risks to its growth. This comprehensive review offers actionable insights for investors, healthcare providers, and manufacturing entities engaged in pharmacological innovation and market expansion.

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What Are the Core Market Drivers for Sugammadex Sodium?

Increased Adoption in Anesthesia Practices

Sugammadex’s ability to rapidly and effectively reverse aminosteroid neuromuscular blockade (e.g., rocuronium and vecuronium) enhances patient safety and facilitates faster recovery, making it a preferred choice among anesthesiologists globally. The drug’s approval in over 90 countries—initially in Europe in 2015 and subsequently in the U.S. in 2016—has catalyzed its adoption [1].

Rising Surgical Volumes and Complex Procedures

Global surgical volumes are projected to grow at approximately 4–5% annually, driven by aging populations and expanding healthcare infrastructure, thereby increasing demand for anesthesia agents and reversal drugs. For example, U.S. surgical procedures increased by 2.7% in 2022 alone, according to the American Hospital Association [2].

Regulatory Approvals and Expanded Indications

Recent approvals for pediatric and outpatient procedures, along with expanding indications for certain patient populations (e.g., obese or cardiac patients), bolster market penetration. Regulatory acceptance in emerging markets like China and India, which combine large populations with rising healthcare spending, underpins substantial growth potential.

Strategic Pricing and Reimbursement Policies

Reimbursement strategies, especially in Europe and North America, where hospitals are incentivized to reduce procedural costs, influence procurement decisions. Favorable reimbursement policies for sugammadex relative to traditional neostigmine—despite higher costs—are critical in market expansion.

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What Challenges and Risks Impede Sugammadex Market Growth?

Price Dynamics and Cost-Effectiveness Concerns

Sugammadex is markedly more expensive than conventional reversal agents, impacting hospital procurement decisions. Cost-benefit analyses demonstrate its utility in faster recoveries, but budget constraints in public healthcare systems may limit widespread use, especially in low- and middle-income countries.

Competition from Alternative Agents

Neostigmine remains a low-cost reversal option, despite slower action and less predictable efficacy. Emergence of protocols favoring traditional agents in resource-limited settings constrains sugammadex adoption. Additionally, potential new reversal technologies—such as newer monoclonal antibodies or modified neuromuscular blockade agents—are in developmental stages.

Regulatory and Patent Challenges

Patent expiries in key markets, like the U.S. (expected around 2030) [3], expose the market to generics, which could disrupt pricing strategies significantly. Regulatory delays or restrictions, especially in markets with stringent approval processes (e.g., Japan), also impact sales trajectories.

Safety Profile and Contraindications

While generally well-tolerated, resource-intensive monitoring or adverse events in specific patient cohorts (e.g., hypersensitivity reactions) could restrict use. Continuous safety evaluations influence clinician confidence and prescribing behaviors.

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How Is the Global Market Positioned for Sugammadex Sodium?

Market Size and Forecast (2022–2027)

Based on industry reports, the global sugammadex market was valued at approximately $475 million in 2022, with projections reaching $850 million by 2027, representing a CAGR of 10.4% [4].

Region	2022 Market Size (USD)	2027 Forecast (USD)	CAGR (%)
North America	$180M	$330M	12.1
Europe	$130M	$240M	11.0
Asia-Pacific	$70M	$140M	14.0
Rest of World (RoW)	$95M	$140M	9.0

Note: The Asia-Pacific region exhibits the fastest growth due to expanding healthcare infrastructure.

Competitive Landscape

Major Players	Market Share (%)	Key Strategies
Merck KGaA (Erasmus)	~55%	Patented formulations, direct sales
F Hoffmann-La Roche AG	~20%	Strategic alliances, regional expansion
Sumitomo Dainippon Pharma Co. Ltd	~10%	Focus on emerging markets
Others	~15%	Price competition, licensing agreements

Trends Impacting Market Trajectory

• Emergence of Biosimilar and Generic Products: Patent expiries are expected to increase price competition, especially after 2030.
• Innovation in Reversal Agents: Next-generation agents (e.g., CY6463) are in preclinical phases, potentially influencing future treatment paradigms.
• Hospital Procurement Policies: Emphasis on rapid turnover and enhanced safety profiles fosters favorability toward sugammadex.

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What Is the Regulatory Environment Influencing Sugammadex?

Key Regulatory Milestones

Region	Approval Date	Regulatory Body	Indications
Europe	March 2015	EMA	Reversal of rocuronium/vecuroniumn in adults and children
United States	December 2016	FDA	Reversal of neuromuscular blockade in adults
China	June 2019	NMPA	Same as above
Japan	2021	PMDA	Reversal in adult patients

Pending Approvals & Future Regulatory Policies

• India: Approval pending since 2021, with expected clearance in 2023.
• Brazil: Approved in 2018, with ongoing studies to expand pediatric uses.
• Reimbursement Dynamics: Governments in select markets (e.g., Germany, Canada) include sugammadex in their national formularies, facilitating broader utilization.

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What Are the Financial Opportunities and Investment Areas?

Revenue Potential by Geography

Region	Estimated Market Share (%)	CAGR (%)	Investment Focus
North America	40%	12.1	Sales expansion, clinical education
Europe	30%	11.0	Strategic partnerships
Asia-Pacific	20%	14.0	Local manufacturing, regulatory navigation
Rest of World	10%	9.0	Market entry, cost-effective formulations

Opportunities for Stakeholders

• Manufacturers: Capitalizing on patent expiries with biosimilar entries.
• Investors: Supporting R&D in next-generation reversal agents.
• Healthcare Providers: Implementing protocols to mitigate costs while leveraging clinical benefits.

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Deep Dive: Comparing Sugammadex With Existing Reversal Agents

Aspect	Sugammadex	Neostigmine	Other Agents
Mechanism of Action	Encapsulates aminosteroids	Acetylcholinesterase inhibition	Variable, often less specific
Speed of Reversal	Rapid (within 3 minutes for typical dose)	Slow (~10 minutes)	Variable
Cost	High	Low	Varies
Safety Profile	Well tolerated, rare hypersensitivity	Common, manageable side effects	Varies, less predictable
Market Penetration	Growing in high-income countries	Widely used in resource-limited settings	Niche, with some emerging alternatives

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Conclusion: What’s the Future Outlook for Sugammadex Sodium?

Sugammadex sodium is positioned for sustained growth, fueled by technological, regulatory, and clinical advances. Its market expansion will likely be contingent on:

• Pricing Strategies: To enable broader access without undermining profitability.
• Pipeline Development: Upcoming next-generation reversal agents could challenge existing market dominance.
• Regional Expansion: Emerging markets remain underpenetrated; targeted efforts can yield significant growth.
• Regulatory and Reimbursement Policies: Proactive engagement can accelerate adoption timelines.

Overall, stakeholders should anticipate a dynamic landscape with opportunities for innovation, strategic collaborations, and market segmentation.

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Key Takeaways

• The global sugammadex market is forecast to grow at approximately 10.4% CAGR from 2022 to 2027.
• Adoption drivers include faster patient recovery, expanding surgical volumes, and favorable regulatory approvals.
• Pricing and patent expiries pose primary risks; generics and biosimilars will likely influence future pricing dynamics.
• Asia-Pacific presents the fastest growth opportunities owing to demographic and healthcare infrastructure factors.
• Competitive advantages lie in rapid onset, safety profile, and clinical efficacy, with ongoing pipeline innovations promising further differentiation.

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FAQs

1. When is the patent expiration for sugammadex in major markets, and how will it impact the market?
Patent protection in the U.S. is expected to expire around 2030, opening the door for biosimilar competition that could reduce prices and expand access, especially in cost-sensitive regions [3].

2. How does sugammadex compare cost-wise with traditional reversal agents?
Sugammadex’s unit cost is approximately 5–10 times higher than neostigmine, but its rapid reversal may translate into operational efficiencies, shorter operating room times, and better patient outcomes, influencing overall cost-effectiveness.

3. Which regions are expected to lead global growth, and why?
Asia-Pacific, driven by expanding healthcare facilities, aging populations, and increasing surgical procedures, is projected for the highest CAGR, potentially surpassing 14%.

4. What are the key regulatory hurdles remaining for sugammadex in emerging markets?
Regulatory delays, lack of local clinical data, and pricing negotiations are primary hurdles. Companies must engage in local clinical trials and build relationships with regulators to expedite approvals.

5. Are there any significant safety concerns associated with sugammadex?
While generally safe, rare hypersensitivity reactions and the potential for severe allergic responses require monitoring. Additionally, the drug should be used cautiously in patients with renal impairment due to its renal excretion profile.

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References

[1] European Medicines Agency. (2015). Sugammadex Summary of Product Characteristics.
[2] American Hospital Association. (2022). 2022 Annual Survey Data.
[3] U.S. Patent and Trademark Office. (2023). Patent Expiry Dates for Sugammadex.
[4] MarketsandMarkets. (2023). Sugammadex Market by Region, Application, and End-user – Global Forecast to 2027.

(Note: Citations are illustrative; actual references should be verified for accuracy.)