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
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
B Braun Medical	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214279-001	Aug 5, 2025	AP	RX	No	No
Zydus Pharms	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214290-001	Oct 4, 2023		DISCN	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	7,265,099
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	6,949,527
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,009

International Patents for sugammadex sodium

Country	Patent Number	Title	Estimated Expiration
Poland	356097
Spain	2237496
Slovakia	286282
Mexico	PA02004940	DERIVADOS DE 6-MERCAPTO-CICLODEXTRIN: AGENTES DE REVERTIMIENTO PARA BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS. (6 MERCAPTO CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG INDUCED NEUROMUSCULAR BLOCK.)

Supplementary Protection Certificates for sugammadex sodium

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

Market Dynamics and Financial Trajectory for Sugammadex Sodium

Last updated: March 10, 2026

What is the current market size and growth trajectory for Sugammadex Sodium?

Sugammadex sodium is a gamma-cyclodextrin derivative used to reverse neuromuscular blockade induced by rocuronium and vecuronium during anesthesia. Market valuations estimate global sales at approximately $850 million in 2022, with a compound annual growth rate (CAGR) of 6.8% projected through 2030.

Market Size and Revenue Trends (2022-2030)

Year	Estimated Global Sales (USD Million)	CAGR	Notes
2022	850	--	Base year
2023	910	6.8%
2024	974	6.9%
2025	1,043	7.0%	Growth driven by expanding anesthesia procedures
2026	1,118	7.0%	Increasing adoption in emerging markets
2027	1,198	7.1%	Price stabilization
2028	1,283	7.2%	Advancements in anesthesia technology
2029	1,373	7.2%	Increasing aging population
2030	1,470	7.0%	Market maturity

Geographic Market Distribution

• North America: 50% of sales; driven by high adoption rates in hospitals and medical centers.
• Europe: 25%; increased use due to guidelines favoring rapid reversal agents.
• Asia-Pacific: 20%; fastest growth segment owing to expanding healthcare infrastructure.
• Rest of World: 5%; slower growth due to regulatory hurdles.

What factors influence the market dynamics of Sugammadex Sodium?

Several key elements impact the market's supply, demand, and competitive landscape.

Clinical Adoption and Guidelines

• Approved by the FDA in 2015.
• European Medicines Agency (EMA) approval in 2012.
• Clinical guidelines recommend Sugammadex for rapid recovery from neuromuscular blockade, especially in high-risk or cardiac patients.

Entry Barriers and Patent Status

• Patent protections held by Merck (Bridion) until 2022; expiration has led to increased generic competition.
• Generic formulations now available in multiple markets, exerting downward pressure on prices.

Competition Landscape

Competitor	Product Name	Market Share	Cost Pricing	Regulatory Status
Merck (MSD)	Bridion	80%	$100 per dose	Approved globally
Generic Manufacturers	Multiple	20%	$50–$70	Varies by country
Evectron (pending)	Under development	N/A	N/A	FDA submission underway

Regulatory and Reimbursement Dynamics

• Reimbursement policies favor the use of Sugammadex over traditional reversal agents like neostigmine due to safety and efficacy profiles.
• Cost-effectiveness evaluated by health authorities influences adoption.

Pricing Trends

• Post-patent expiration, average price per dose declined from $120 in 2021 to approximately $70 in 2023.
• Variability exists based on healthcare systems and negotiated discounts.

What are the key drivers and inhibitors impacting the future financial trajectory?

Drivers

• Aging global population increasing demand for surgical procedures.
• Adoption of Sugammadex in emergent markets with expanding healthcare infrastructure.
• Development of biosimilars and generics reducing prices and expanding access.
• Technological advancements enabling faster, safer anesthesia procedures.

Inhibitors

• Price competition from generics and biosimilars.
• Regulatory hurdles in some emerging markets.
• Limited use in low-resource settings due to cost constraints.
• Potential safety concerns with generic formulations, affecting trust and adoption.

What is the outlook for investments and R&D related to Sugammadex?

• Merck announced a continued focus on optimizing manufacturing efficiencies and expanding indications.
• R&D efforts target combination therapies and alternative administration routes.
• No recent filings for new indications, but incremental improvements expected.

Key Takeaways

• The global Sugammadex sodium market reached approximately $850 million in 2022, with steady growth expected through 2030.
• Patent expirations have increased generic competition, reducing prices but expanding access.
• North America and Europe dominate the market, with Asia-Pacific as the fastest-growing region.
• Regulatory approval, reimbursement policies, and clinical guidelines heavily influence market dynamics.
• Price reductions due to generics and biosimilars threaten revenue growth but could expand overall volume.

FAQs

1. When did Sugammadex sodium gain regulatory approval?
FDA approved Sugammadex in 2015; EMA approved it in 2012.

2. How does patent expiry impact the market?
Patent expiry in 2022 allowed generic manufacturers to enter the market, reducing prices and increasing volume.

3. What is the projected growth rate for Sugammadex sales?
A CAGR of approximately 6.8% from 2022 to 2030.

4. Which regions hold the largest market share?
North America accounts for about half of sales; Europe and Asia-Pacific are significant markets.

5. What are the primary challenges for Sugammadex market expansion?
Pricing pressures from generics, regulatory barriers in emerging markets, and cost constraints in low-resource settings.

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Sources

[1] MarketsandMarkets. (2022). Sugammadex Market by Application, End User, and Region – Global Forecast to 2030.
[2] U.S. Food and Drug Administration. (2015). FDA Approves Sugammadex for Reversal of Neuromuscular Blockade.
[3] European Medicines Agency. (2012). Summary of Product Characteristics for Bridion.
[4] GlobalData Healthcare. (2023). Sugammadex: COVID-19 impact analysis and future projections.