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:	32
Clinical Trials:	65
Patent Applications:	208
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
Korea University Ansan Hospital	Phase 4
Seoul National University Hospital	N/A
Radboud University Medical Center	Phase 2

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	022225-001	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	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	022225-001	Dec 15, 2015	6,949,527
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	7,265,009

International Patents for BRIDION

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

Country	Patent Number	Title	Estimated Expiration
China	1370073
Japan	4563972
China	1188428
World Intellectual Property Organization (WIPO)	0140316
Norway	328790
Australia	7508900
South Africa	200203538	6-mercapto-cyclodextrin derivatives; reversal agents for drug-induced neuromuscular block.

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	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550	340	Finland
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

Last updated: July 3, 2025

Introduction

In the fast-paced world of pharmaceuticals, understanding a drug's market position and financial outlook can drive strategic decisions for investors and executives alike. Bridion, the brand name for sugammadex sodium, stands out as a critical tool in surgical anesthesia, reversing the effects of neuromuscular blocking agents to ensure safer patient outcomes. Developed by Merck & Co. (known as MSD outside the U.S.), this drug has carved a niche in anesthesiology since its FDA approval in 2015. As healthcare demands grow globally, Bridion's trajectory offers valuable insights into innovation, competition, and revenue potential—key factors that business leaders must monitor to navigate market volatility.

Overview of Bridion

Bridion operates as a selective relaxant binding agent, rapidly reversing the paralysis induced by rocuronium and vecuronium during surgeries. This mechanism enhances operating room efficiency and reduces recovery times, addressing a pressing need in modern healthcare systems. Merck launched Bridion after extensive clinical trials, securing approvals from major regulators like the FDA and EMA. By 2023, it had become a staple in hospitals worldwide, particularly in regions with high surgical volumes such as North America and Europe.

The drug's patent landscape remains a focal point for analysts. Merck's original patents, filed in the early 2000s, provided exclusivity until recent years, shielding Bridion from generics. However, as patents begin to expire—such as the core composition patent in the U.S. in 2023—competition intensifies. This shift underscores the drug's evolution from a premium-priced innovation to a potentially commoditized product, influencing its long-term market dynamics.

Market Dynamics

The global market for neuromuscular blockade reversal agents has expanded rapidly, driven by rising surgical procedures and an aging population. Bridion commands a significant share, estimated at 40-50% in key markets like the U.S. and EU, according to recent industry data. In 2023, the overall market for these agents reached approximately $1.5 billion, with Bridion contributing around $600 million in sales for Merck.

Competition remains fierce, with players like GlaxoSmithKline and emerging generics from Teva Pharmaceuticals challenging Bridion's dominance. Teva's entry into the U.S. market in late 2023, following patent expiration, has eroded prices by up to 30% in some regions. Regulatory factors further shape this landscape: The FDA's stringent post-market surveillance requires Merck to maintain robust safety data, while the EMA's adaptive pathways could accelerate approvals for next-generation formulations.

Emerging trends favor Bridion's growth. The surge in minimally invasive surgeries, projected to increase by 15% annually through 2030, boosts demand for rapid-reversal agents. Additionally, in Asia-Pacific markets like China and India, where surgical volumes are rising due to improved healthcare infrastructure, Bridion's adoption has doubled since 2020. Merck actively expands here through partnerships, such as its distribution deals in China, capitalizing on local manufacturing incentives.

However, supply chain disruptions pose risks. Global events, including the COVID-19 pandemic, highlighted vulnerabilities in active pharmaceutical ingredient sourcing, causing Bridion shortages in 2021-2022. Merck addressed this by diversifying suppliers, but ongoing geopolitical tensions could introduce further instability. Analysts predict that by 2025, the market will stabilize, with Bridion maintaining a 35% share amid growing biosimilar threats.

Financial Trajectory

Merck's financial performance with Bridion reflects both steady growth and emerging headwinds. From 2016 to 2023, global sales of Bridion surged from $200 million to over $600 million, driven by expanded indications and market penetration. In 2022 alone, the drug generated $550 million in revenue, representing a 12% year-over-year increase, as reported in Merck's annual filings. This growth stems from pricing power in protected markets and volume gains in emerging economies.

Looking ahead, projections indicate moderated expansion. Analysts from Evaluate Pharma forecast Bridion's sales to reach $700 million by 2025, assuming no major generic disruptions. However, patent expirations could cut revenues by 25-40% post-2026, as generics capture market share. Merck counters this through strategic pricing adjustments—lowering costs in competitive regions while premiumizing in high-value markets like the U.S.

Financial metrics reveal Bridion's profitability. Its gross margin hovers around 75%, thanks to efficient manufacturing and minimal R&D costs post-launch. Merck's overall earnings per share have benefited, with Bridion contributing 2-3% to the company's pharmaceutical segment profits in recent quarters. Yet, external factors like inflation and currency fluctuations have impacted net revenues; for instance, a stronger U.S. dollar in 2023 reduced reported sales by 5% in international markets.

Investors should note Merck's diversification efforts, including pipeline investments in related anesthesia products. These initiatives aim to sustain Bridion's financial momentum, with potential licensing deals projected to add $100-200 million in annual revenue by 2028. Overall, the drug's trajectory points to a peak phase through 2025, followed by a gradual decline unless innovation reinvigorates its position.

Challenges and Opportunities

Bridion faces hurdles such as regulatory scrutiny over rare side effects, like hypersensitivity reactions, which prompted FDA warnings in 2022. This has led to cautious prescribing in some hospitals, potentially capping market growth at 5-7% annually. Pricing pressures from payers, including U.S. insurers demanding rebates, further squeeze margins.

On the flip side, opportunities abound. The integration of Bridion into enhanced recovery after surgery (ERAS) protocols could expand its use in outpatient settings. Merck's ongoing trials for pediatric indications, if approved by 2025, would open new revenue streams in a $300 million sub-market. Moreover, sustainability trends favor Bridion's eco-friendly profile, as it requires less waste in production compared to alternatives, appealing to environmentally conscious healthcare providers.

Conclusion

Bridion's market dynamics and financial trajectory highlight the interplay of innovation, regulation, and competition in pharmaceuticals. As Merck navigates patent cliffs and global expansion, the drug remains a bellwether for anesthesia advancements, offering lessons for industry stakeholders on adapting to change.

Key Takeaways

• Bridion holds a strong market position in neuromuscular reversal agents, with sales exceeding $600 million in 2023, but faces generic threats post-patent expiration.
• Revenue growth is projected at 5-10% annually through 2025, driven by emerging markets, though challenges like pricing pressures could temper gains.
• Merck's strategic investments in new indications and partnerships position Bridion for sustained profitability amid evolving healthcare demands.
• Regulatory and supply chain risks underscore the need for diversified operations to protect financial stability.
• Investors should monitor competition and innovation to assess long-term value in this segment.

FAQs

1. What factors are driving Bridion's market growth? Bridion's expansion is fueled by increasing surgical volumes and its rapid reversal capabilities, particularly in regions like Asia-Pacific where demand for efficient anesthesia solutions is rising.
2. How have patent expirations affected Bridion's finances? Since key patents expired in 2023, generics have entered the market, potentially reducing Bridion's revenues by 25-40% in affected regions through price competition.
3. What role does Bridion play in modern surgery? Bridion enhances patient safety by quickly reversing neuromuscular blockers, allowing faster recovery and supporting protocols like ERAS in hospitals worldwide.
4. How is Merck responding to competition for Bridion? Merck is countering rivals by pursuing new indications, adjusting pricing strategies, and forming distribution partnerships to maintain market share.
5. What future trends could impact Bridion's trajectory? Trends such as the growth of minimally invasive procedures and potential pediatric approvals could boost demand, while supply chain issues and regulatory changes pose risks to its financial outlook.

Sources Cited

1. U.S. Food and Drug Administration. "FDA Approval Letter for Bridion (sugammadex)." Accessed via FDA website, 2015.
2. Merck & Co. Inc. "Annual Financial Report and 10-K Filing." Available on Merck's investor relations page, 2022 and 2023.
3. Evaluate Pharma. "World Preview 2023, Outlook to 2030." Industry report on pharmaceutical sales projections, 2023 edition.