BRIDION Drug Patent Profile

When do Bridion patents expire, and when can generic versions of Bridion launch?

Bridion is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in thirty countries.

The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bridion

A generic version of BRIDION was approved as sugammadex sodium by ASPIRO on June 9^th, 2023.

Summary for BRIDION

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	67
Patent Applications:	47
Drug Prices:	Drug price information for BRIDION
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIDION
What excipients (inactive ingredients) are in BRIDION?	BRIDION excipients list
DailyMed Link:	BRIDION at DailyMed

See drug prices for BRIDION

Recent Clinical Trials for BRIDION

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

Sponsor	Phase
Tamas Vegh, MD	PHASE4
Korea University Ansan Hospital	Phase 4
Seoul National University Hospital	N/A

See all BRIDION clinical trials

Pharmacology for BRIDION

Paragraph IV (Patent) Challenges for BRIDION

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 BRIDION

BRIDION is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No					Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes					Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes

Expired US Patents for BRIDION

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
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015

International Patents for BRIDION

See the table below for patents covering BRIDION around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0140316
Taiwan	200631099	Method of forming HDP-CVD pre-metal dielectric layer
Slovakia	286282
Norway	2010019
Taiwan	I242015
South Korea	100716524

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BRIDION (Suggamadex)

Last updated: July 27, 2025

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Introduction

BRIDION (sugammadex) has established itself as a pivotal agent in reversibly blocking neuromuscular blockade induced by aminosteroid non-depolarizing neuromuscular blocking agents. Developed by Merck & Co. (known as MSD outside the U.S. and Canada), it addresses critical needs in anesthesia management, notably for rapid recovery of neuromuscular function post-surgery. This analysis examines current market dynamics, competitive landscape, regulatory influences, revenue projections, and strategic factors shaping BRIDION's financial trajectory.

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Market Overview and Growth Drivers

The global anesthetic reversal agents market is projected to grow significantly, driven by increasing surgical procedures and expanding adoption of advanced anesthesia management tools. According to industry reports, the market is expected to surpass USD 7 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 6-7%[1].

BRIDION’s success hinges on several key factors:

• Rising Surgical Volumes: The global increase in outpatient and inpatient surgeries, especially in developed regions like North America and Europe, boosts demand for efficient neuromuscular reversal agents.

• Advancements in Anesthesia Techniques: The shift towards neuromuscular monitoring and rapid recovery protocols enhances the utility of sugammadex.

• Patient Safety and Regulatory Approvals: BRIDION's FDA approval in 2015 and subsequent approvals in Europe, Japan, and other markets solidify its position.

• Healthcare Cost Efficiency: Reduced postoperative complications and shorter hospital stays position BRIDION as a cost-effective solution, influencing institutional formulary decisions.

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Market Dynamics

Competitive Landscape

BRIDION faces competition primarily from traditional reversal agents like neostigmine and pyridostigmine. However, sugammadex offers rapid and predictable reversal, especially with deep neuromuscular blockade, a significant advantage over acetylcholinesterase inhibitors[2].

Additionally, emerging alternatives explore different mechanisms or formulations, but none currently threaten BRIDION's market dominance substantively.

Patent Life and Generic Competition

Merck’s patent protection for sugammadex expired in some territories in the late 2020s, prompting concerns over generic entry. While the U.S. patent expired in 2019, Merck undertook legal defenses to delay generic competition, including patent litigations. Nonetheless, the potential erosion of exclusivity in certain markets could impact revenue streams.

Regulatory and Reimbursement Policies

Reimbursement frameworks significantly influence BRIDION's adoption. In the U.S., it is classified as a controlled substance due to its administration route, adding billing complexity. However, its demonstrated safety can justify higher reimbursement rates. Regulatory hurdles in emerging markets can delay approvals, curbing growth prospects.

Clinical Practice Trends

Increased utilization of neuromuscular monitoring and anesthesia protocols favor sugammadex. Notably, the adoption in high-acuity procedures, including cardiac and bariatric surgeries, has expanded its market.

Pricing Strategies and Market Penetration

Merck maintains premium pricing for BRIDION reflective of its clinical benefits. Market penetration relies on anesthesiologist education, hospital formulary inclusion, and regional healthcare infrastructure capabilities.

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Financial Trajectory

Historical Performance

Since its launch, BRIDION has demonstrated strong growth trajectories within Merck’s anesthesia portfolio. In 2021, sales exceeded USD 1.1 billion globally, reflecting robust uptake[3].

Projection and Future Revenue Streams

Forecasts anticipate continued growth, assuming:

• Market Expansion: Penetration into emerging markets, where anesthesia practices evolve, could unlock significant volume increases. Currently, North America and Europe constitute ~70% of sales.

• Pricing Power and Market Share: As patent protections in certain regions lapse, generic competition could pressure margins, though Merck’s strategies, such as expanding indications (e.g., pediatric uses) and educational outreach, could sustain premium prices.

• Pipeline and Label Expansion: Ongoing trials evaluating sugammadex’s efficacy in new indications or formulations (e.g., oral or outpatient use) could open new revenue avenues.

Analysts project BRIDION could sustain a CAGR of approximately 6-8% over the next five years, reaching USD 1.8–2 billion globally by 2027[4].

Risks and Challenges

• Patent Expiry and Generic Competition: Entry of generics may significantly reduce prices and revenues.

• Regulatory Delays: New approvals in key markets could be hampered, affecting market expansion.

• Market Penetration Barriers: Variations in clinical practice patterns and healthcare infrastructure limitations influence adoption rates.

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Strategic Considerations

Merck’s strategic focus includes:

• Expanding Indications: Clinically studied for use in elderly and pediatric populations, broadening the patient base.

• Educating Clinicians: Training and awareness campaigns to foster early adoption.

• Pricing and Reimbursement Negotiations: Engaging health authorities to secure favorable reimbursement pathways.

• Pipeline Development: Investigating formulations that facilitate outpatient surgery applications or combination therapies.

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Conclusion

BRIDION remains a high-value product within Merck’s portfolio, with favorable market dynamics driven by increasing surgical procedures, clinical advantages over competitors, and expanding global access. However, patent expiries and emerging competition pose challenges that require strategic management. Continued innovation, market expansion, and regulatory engagement will be critical to sustaining its positive financial trajectory.

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Key Takeaways

• Growth Potential: BRIDION’s revenues are poised for steady growth, supported by expanding surgical volumes and clinical adoption.

• Competitive Advantage: Its rapid and predictable reversal profile consolidates its position over traditional agents.

• Market Risks: Patent expiration and potential generics could pressure prices and market share.

• Strategic Focus: Diversification into new indications and geographic markets will be vital for sustained growth.

• Regulatory and Reimbursement Policies: Navigating these frameworks remains crucial to maximize market penetration.

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FAQs

Q1: How does sugammadex differ from traditional neuromuscular reversal agents?
A: Sugammadex offers rapid, predictable reversal of aminosteroid neuromuscular blockers like rocuronium and vecuronium, particularly at deep blockade levels, with fewer side effects compared to acetylcholinesterase inhibitors such as neostigmine.

Q2: What are the main factors influencing BRIDION's market growth?
A: Increasing surgical procedures, technological advances, clinician familiarity, regulatory approvals, and healthcare infrastructure improvements primarily drive growth.

Q3: How will patent expiries affect BRIDION’s future revenues?
A: Patent expiries signal potential for generic competition, which could reduce prices and sales volumes, impacting revenue unless Merck adopts strategic responses such as formulation patents or expanded indications.

Q4: What is Merck’s strategy to sustain BRIDION’s market leadership?
A: Merck focuses on expanding indications, investing in clinician education, optimizing pricing and reimbursement negotiations, and exploring new formulations or delivery methods.

Q5: Are there emerging competitors to BRIDION?
A: Currently, no direct competitors match sugammadex’s efficacy; however, future innovations in neuromuscular blockade reversal could pose competitive threats.

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References

[1] MarketWatch. Anesthetic reversal agents market size, share, growth forecast. 2022.
[2] Lunn, M., & Paskins, T. (2020). Clinical advantages of sugammadex over neostigmine. Anesthesia & Analgesia.
[3] Merck Annual Report 2021.
[4] GlobalData. Sugammadex market analysis and forecasts. 2022.