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. Two 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:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	65
Patent Applications:	130
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		Y	Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes	RE44733		Y	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

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	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

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)	0112202
European Patent Office	1210090	UTILISATION D'AGENTS CHIMIQUES CHELATANTS COMME AGENTS DE NEUTRALISATION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES MEDICAMENTS (USE OF CHEMICAL CHELATORS AS REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK)
Japan	4782334
Germany	122008000068

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	91501	Luxembourg		91501, EXPIRES: 20230725
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725

BRIDION Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Bridion

Introduction

Bridion, known generically as sugammadex, is a significant addition to Merck's pharmaceutical portfolio, particularly in the hospital and acute care segment. Approved by the FDA in 2015, Bridion is used to reverse the effects of neuromuscular-blocking agents, facilitating quicker recovery for patients undergoing surgery. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

FDA Approval and Initial Market Entry

Bridion's approval marked a significant milestone after being rejected three times previously. The drug was finally cleared for use in the U.S. market, joining Merck's lineup of hospital-focused medications[1].

Clinical Use and Benefits

Bridion is designed to reverse the effects of neuromuscular-blocking drugs such as rocuronium and vecuronium. This allows patients to recover from anesthesia more quickly, reducing the time spent on breathing machines and enabling them to breathe on their own sooner. Despite potential side effects like bradycardia and severe allergic reactions, Bridion has been widely adopted globally[1][4].

Market Performance

Since its approval, Bridion has shown robust growth. In its first year on the U.S. market, it contributed $262 million to Merck's hospital business, which totaled $2.5 billion for the first nine months of 2015. This growth was part of Merck's strategy to leverage its stronger drugs to boost newer products[1].

Sales Trajectory

Bridion's sales have continued to increase sharply over the years. By the 51st quarter on the market (Q1 2021), Bridion had achieved $311.77 million in sales, outperforming many other antimicrobial and non-antimicrobial drugs in similar cohorts[3].

In 2022, Bridion generated nearly $1.7 billion in revenue, marking a 10% increase from 2021. By the first quarter of 2023, it had brought in $487 million, a 23% increase from the same period in the previous year. This made Bridion Merck's fifth best-selling drug at the time[4].

Patent Protection and Market Exclusivity

A crucial factor in Bridion's financial success is its extended patent protection. In June 2023, Merck secured a patent ruling that extends Bridion's protection from generic competition until at least January 2026. This ruling is significant as it allows Merck to maintain market exclusivity and continue investing in research and development[4].

Competitive Landscape

Bridion operates within a competitive hospital and acute care market. Merck's strategy involves marketing its hospital range together, using established drugs to support newer ones. For example, Bridion is part of a portfolio that includes antibiotics and antifungal treatments acquired from Cubist Pharmaceuticals[1].

Financial Impact on Merck

Bridion's performance has been a key driver of Merck's hospital business growth. In 2020, Merck's pharmaceutical sales increased by 3% to $43.0 billion, with the hospital segment contributing significantly to this growth. By 2023, Merck's overall sales reached $60.115 billion, with Bridion playing a substantial role in this figure[2][5].

Challenges and Future Outlook

Despite its success, Bridion faces potential challenges, including the risk of generic competition once its patent protection expires. However, Merck's ongoing investments in research and development, coupled with the drug's strong market performance, position Bridion for continued growth. The company aims to achieve revenue targets of over $20 billion in the next decade, with Bridion expected to be a significant contributor[4].

Industry Expert Insights

Industry experts highlight the importance of patent protection in maintaining market exclusivity and driving revenue. "The patent term extension returns some of the time lost during regulatory review and prolongs the product’s market exclusivity," said Jennifer Zachary, executive vice president and general counsel at Merck. This extended protection is crucial for continued investment in innovative medicines and vaccines[4].

Statistical Highlights

• Sales Growth: Bridion's sales increased by 23% in the first quarter of 2023 compared to the same period in 2022[4].
• Revenue Contribution: In 2022, Bridion generated nearly $1.7 billion in revenue, making it Merck's sixth top-selling drug[4].
• Market Performance: By the 51st quarter on the market, Bridion achieved $311.77 million in sales, outperforming many other drugs in similar cohorts[3].

Key Takeaways

• Robust Growth: Bridion has shown consistent and significant growth since its FDA approval in 2015.
• Extended Patent Protection: The drug's patent protection until January 2026 ensures continued market exclusivity and revenue growth.
• Strategic Marketing: Merck's strategy of marketing its hospital range together has helped boost Bridion's sales.
• Financial Impact: Bridion is a key contributor to Merck's overall revenue and growth targets.
• Future Outlook: Despite potential challenges, Bridion is expected to continue driving Merck's hospital business growth.

FAQs

What is Bridion used for?

Bridion is used to reverse the effects of neuromuscular-blocking agents such as rocuronium and vecuronium, allowing patients to recover from anesthesia more quickly.

When was Bridion approved by the FDA?

Bridion was approved by the FDA in December 2015 after being rejected three times previously.

How has Bridion's sales performance been since its approval?

Bridion has shown robust growth, with sales increasing sharply over the years. By 2023, it had become Merck's fifth best-selling drug, generating nearly $1.7 billion in revenue in 2022.

What is the current patent status of Bridion?

Bridion's patent protection has been extended until at least January 2026, ensuring continued market exclusivity.

How does Bridion fit into Merck's overall business strategy?

Bridion is part of Merck's hospital and acute care segment, and the company markets it as part of a broader portfolio of hospital drugs to drive growth and revenue.

Sources

1. FiercePharma - Merck finally adds postsurgery med Bridion to its U.S. lineup. Will hospital buyers step up?
2. BusinessWire - Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results
3. NCBI - MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs
4. BioSpace - Merck Secures Bridion Patent Protection Through January 2026
5. Merck - Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results