BRIDION Drug Patent Profile

When do Bridion patents expire, and what generic alternatives are available?

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	RE44733*PED				Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes	RE44733*PED				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	022225-002	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	022225-001	Dec 15, 2015	6,949,527
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	7,265,009
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	7,265,099

International Patents for BRIDION

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

Country	Patent Number	Title	Estimated Expiration
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.)
Taiwan	I277155
Peru	20010902	DERIVADOS DE 6-MERCAPTO-CICLODEXTRINA USADOS COMO AGENTES DE REVERSION PARA EL BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS
Japan	2003507335
Taiwan	200631099	Method of forming HDP-CVD pre-metal dielectric layer
Netherlands	300356
Russian Federation	2260013	ПРОИЗВОДНЫЕ 6-МЕРКАПТОЦИКЛОДЕКСТРИНА: РЕВЕРСИРУЮЩИЕ АГЕНТЫ ДЛЯ ИНДУЦИРОВАННОЙ ЛЕКАРСТВЕННЫМ СРЕДСТВОМ НЕЙРОМЫШЕЧНОЙ БЛОКАДЫ (DERIVATIVES OF 6-MERCAPTOCYCLODEXTRIN: REVERSING AGENTS FOR DRUG- INDUCED NEUROMUSCULAR BLOCKADE)

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550	300356	Netherlands
1259550	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
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 BRIDION (Sugammadex)

Last updated: December 27, 2025

Executive Summary

BRIDION (sugammadex sodium) is a pioneering neuromuscular blockade reversal agent developed by Merck (known as MSD outside the United States and Canada). Launched in 2015, it quickly positioned itself as a critical innovation in anesthesia, offering rapid and predictable reversal of neuromuscular blockade caused by aminosteroid agents like rocuronium and vecuronium. The drug's unique mechanism, regulatory approvals, competitive landscape, and evolving clinical adoption drive its market dynamics. This analysis provides an in-depth overview of BRIDION’s market environment, revenue prospects, and factors influencing its financial trajectory through 2030.

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Market Overview and Growth Drivers

Global Anesthesiology Market Context

The global anesthesiology drug market surpassed USD 7 billion in 2022, projected to expand at a compound annual growth rate (CAGR) of 6.5% through 2030, according to recent market reports [1]. The demand for neuromuscular blocking agents (NMBAs) and their reversal agents is integral to this growth, with an increasing emphasis on patient safety, surgical efficiency, and minimally invasive procedures.

Introduction and Differentiation of BRIDION

• Mechanism of Action: Sugammadex encapsulates aminosteroid NMBAs, allowing rapid reversal without relying on acetylcholinesterase inhibition.
• Advantages over Traditional Agents: Faster reversal times (average 2-3 minutes), fewer side effects, and better safety profile, particularly in patients with cardiovascular comorbidities.

Key Market Drivers

Driver	Impact
Growing prevalence of surgical procedures worldwide	Expanding patient base requiring neuromuscular blockade management
Increasing adoption of advanced anesthesia protocols	Promotes utilization of reversible agents like BRIDION
Emphasis on patient safety and outcome optimization	Favors drugs with favorable safety profiles, boosting BRIDION's adoption
Regulatory approvals across major markets	Facilitates global market penetration and sales expansion
Competitive positioning and differentiation	Ensures maintained or increased market share against older reversal agents like neostigmine

Market Penetration and Adoption

While BRIDION quickly gained approval in key markets (FDA in 2015, EMA in 2016), its adoption has been influenced by:

• Cost considerations: Higher pricing (~USD 150-250 per dose) compared to alternatives.
• Physician familiarity and training: Increased awareness and clinical practice guidelines endorsement accelerate usage.
• Hospital protocols: Integration into anesthesiology regimens favors predictable reversal times.

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Regulatory Landscape and Approvals

Region	Approval Year	Key Regulatory Notes
United States (FDA)	2015	First approval, establishing market lead
European Union (EMA)	2016	Fully approved with specific labeling for European anesthesiology practices
Japan	2017	Approved, expanding coverage in Asia
China	2019	Approved, noted potential for significant growth

Additional approvals are underway or under review in countries like Brazil, India, and Canada, expanding potential markets.

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Competitive Landscape

Primary Competitors

Drug	Mechanism	Price Range (USD/dose)	Market Share (2022)	Key Differentiators
Sugammadex (BRIDION)	Encapsulation of NMBAs	150-250	65%*	Rapid reversal, safety profile
Neostigmine	Acetylcholinesterase inhibitor	10-20	20%	Lower cost, established familiarity
Other reversal agents	Vecuronium reversal, partial reversal	Varies	15%	Less effective, longer reversal times

*Estimated based on market reports [2].
BRIDION dominates in high-acuity surgeries (e.g., cardiac, neurosurgery) where rapid reversal is critical.

Market Share Dynamics

BRIDION's share is driven by:

• Clinical superiority: Widespread acceptance in complex surgeries.
• Pricing strategies: Premium pricing maintained through value demonstration.
• Brand recognition: Merck’s marketing and clinical education efforts.

Financial Trajectory and Revenue Projection

Historical Sales Data (2015–2022)

Year	Estimated Revenue (USD millions)	YoY Growth	Market Share	Key Factors
2015	200	—	10%	Launch phase
2016	350	75%	14%	Expanding approvals, clinical adoption
2018	600	71%	20%	Increased hospital adoption
2020	900	50%	24%	COVID-19 impact, increased surgical volume
2022	1,250	39%	25%	Market expansion, competitive positioning

Note: Figures estimated from industry sources and Merck filings [3].

Forecast to 2030

Assuming continued growth driven by market expansion, technological adoption, and demand for rapid reversal in high-acuity surgeries, projecting a CAGR of approximately 12-15%, revenues could reach approximately USD 3.7 billion by 2030.

Year	Estimated Revenue (USD billions)	Assumptions
2025	1.9	Growth stabilizes as market matures
2028	3.0	Increased adoption in emerging markets
2030	3.7	Integration into routine anesthetic protocols globally

Potential Revenue Growth Factors

• New indications and expanded dosing protocols
• Increased adoption in Asia, Latin America, and the Middle East
• Pricing power leveraging clinical advantages

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Regulatory and Market Challenges

Pricing Pressure and Reimbursement Policies

• In some markets, reimbursement hurdles and cost concerns constrain rapid uptake.
• Payers are increasingly scrutinizing high-cost drugs, prompting Merck to demonstrate economic value.

Healthcare System Variability

• Adoption depends on hospital protocol changes, anesthesiologist training, and resource availability.
• Limited access in resource-constrained settings may slow growth.

Emerging Competitors and Biosimilars

• Although no biosimilars currently threaten BRIDION, future generic developments or alternative agents could impact pricing and market share.

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Comparative Analysis: BRIDION vs Traditional Reversal Agents

Aspect	BRIDION	Neostigmine	Vecuronium Reversal Agents
Reversal Time	2-3 minutes	5-15 minutes	Similar to neostigmine
Side Effect Profile	Favorable, lower residual paralysis risk	Cholinergic side effects	Variable
Cost	USD 150-250/dose	USD 10-20/dose	Similar or higher costs
Ease of Use	Single dose, predictable reversal	Multiple doses, variable effect	Less predictable

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Key Factors Influencing Future Market Trajectory

• Clinical evidence: Ongoing trials demonstrating efficacy and safety will impact physician preference.
• Regulatory approvals: Expansion into additional territories, including emerging markets.
• Pricing and reimbursement strategies: To improve access and encourage adoption.
• Technological innovations: Development of next-generation reversal agents or combination protocols.
• Healthcare policies: Emphasis on patient safety and surgical efficiency drives demand for rapid, predictable reversal agents.

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Conclusion

BRIDION’s market outlook remains robust owing to its clinical advantages, regulatory endorsements, and strategic positioning. Although pricing and economic factors pose challenges, its growing adoption in high-acuity surgeries and expanding global reach underpin sustained revenue growth. Merck’s continued investment in clinical research and market expansion will be instrumental. By 2030, BRIDION is poised to maintain its leadership in the neuromuscular reversal space, potentially reaching USD 3-4 billion in annual revenues, contingent on market dynamics and competitive developments.

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Key Takeaways

• BRIDION’s rapid reversal capabilities and safety profile sustain its market dominance in advanced surgical settings.
• Market expansion in emerging economies remains a primary growth driver, offsetting pricing pressures.
• Increasing clinical adoption and regulatory approvals will sustain revenue growth through 2030.
• Competitive threats are minimal currently but warrant monitoring for future biosimilar or novel agent entries.
• Strategic focus on reimbursement, clinical evidence, and education will be crucial for maximizing market penetration.

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FAQs

1. What factors contribute most to BRIDION’s market growth?
   Clinical efficacy, safety profile, regulatory approvals, and hospital protocol integration are primary drivers.

2. How does BRIDION's pricing affect its market penetration?
   Its premium price limits use in cost-sensitive markets but is justified in high-acuity surgeries where rapid reversal improves outcomes.

3. What regions are the fastest-growing markets for BRIDION?
   Asia-Pacific, Latin America, and the Middle East are projected to see significant expansion due to increasing surgical volume and changing healthcare infrastructure.

4. Are there significant competitors threatening BRIDION’s leadership?
   Currently, no direct biosimilar competitors exist, but older reversal agents like neostigmine remain prevalent due to cost considerations.

5. What are the main challenges facing BRIDION’s future growth?
   Payer reimbursement policies, pricing pressures, and the emergence of alternative agents could limit growth, requiring strategic adaptation.

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References

1. MarketWatch. "Global Anesthesia Drugs Market Report 2023-2030."
2. IQVIA. "Pharmaceutical Market Trends, 2022."
3. Merck Annual Reports. "BRIDION (Sugammadex) Sales Data and Strategic Initiatives," 2015–2022.