BREVIBLOC Drug Patent Profile

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

Brevibloc is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in BREVIBLOC is esmolol hydrochloride. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brevibloc

A generic version of BREVIBLOC was approved as esmolol hydrochloride by HIKMA on August 10^th, 2004.

Summary for BREVIBLOC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	16
Patent Applications:	791
Drug Prices:	Drug price information for BREVIBLOC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREVIBLOC
What excipients (inactive ingredients) are in BREVIBLOC?	BREVIBLOC excipients list
DailyMed Link:	BREVIBLOC at DailyMed

See drug prices for BREVIBLOC

Recent Clinical Trials for BREVIBLOC

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

Sponsor	Phase
Zagazig University	Phase 2
Cristália Produtos Químicos Farmacêuticos Ltda.	Phase 4
University Hospital Bispebjerg and Frederiksberg	Phase 4

See all BREVIBLOC clinical trials

Pharmacology for BREVIBLOC

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for BREVIBLOC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988		DISCN	No	No
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	AP	RX	Yes	Yes
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003	AP	RX	Yes	Yes

Expired US Patents for BREVIBLOC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003

International Patents for BREVIBLOC

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0065542	COMPOUNDS SUITABLE FOR TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
Denmark	1368019
Japan	S61501775

Market Dynamics and Financial Trajectory for BREVIBLOC

Last updated: July 27, 2025

Introduction

BREVIBLOC, known generically as esmolol, is a short-acting beta-1 selective adrenergic receptor antagonist primarily used for intraoperative and postoperative management of tachycardia, supraventricular dysrhythmias, and other acute cardiovascular conditions. Since its FDA approval in 1982, BREVIBLOC has maintained a niche position within the cardiovascular therapeutic landscape. This report explores the evolving market dynamics, competitive landscape, regulatory influences, and financial projections shaping BREVIBLOC’s future trajectory.

Market Overview

Historical Context and Therapeutic Profile

Esmolol’s rapid onset and short duration of action make it unique among beta-blockers, facilitating precise perioperative cardiovascular management. Its pharmacokinetic profile—half-life approximately 9 minutes—enables quick titration, minimizing systemic side effects. Historically, BREVIBLOC’s primary market has been hospitals, particularly cardiothoracic and anesthesiology units, owing to its IV formulation.

Market Size and Segmentation

Global demand for acute cardiovascular medications, including beta-blockers like esmolol, has shown steady growth, driven by increasing surgical volumes and advancing critical care practices. In 2022, the global hospital-based cardiovascular drug market was valued at approximately $28 billion, with beta-blockers constituting a significant segment [1].

Within this sector, BREVIBLOC’s market share, although stable, faces emerging challenges from newer agents offering alternative routes of administration, broader indications, or improved safety profiles. The immediate perioperative setting remains its core market, with minimal penetration into outpatient or chronic therapy domains.

Emerging Market Drivers

• Growing Surgical Volumes: An aging population and expanding health infrastructure elevate the demand for safe perioperative cardiovascular management.
• Advances in Critical Care: Growing adoption of rapid, titratable intravenous agents enhances the utility of BREVIBLOC in emergency and intensive care scenarios.
• Regulatory Approvals and Label Expansions: Indications such as off-label use or expanded approved uses could catalyze market penetration.

Competitive Landscape

Key Competitors and Substitutes

Esmolol faces competition from both branded and generic beta-blockers:

• Labetalol and Metoprolol: Oral agents increasingly used perioperatively.
• Other IV Beta-Blockers: Agents like propranolol and atenolol, though less commonly used acutely.
• Emerging Alternatives: Ultrashort-acting agents such as landiolol, with higher beta selectivity and reduced side effect profiles, have begun gaining favor in some markets, particularly Japan and Europe.

Lanolol and Landiolol as Disruptors

Landonolol’s higher beta-1 selectivity and better pharmacokinetic profile position it as a potential market disruptor. Its approval and commercial success in Japan highlight regional differences and suggest that BREVIBLOC may face increased competition as similar agents gain acceptance globally.

Generic Entry and Pricing Trends

Esmolol’s patent exclusivity expired decades ago; consequently, generic versions dominate, exerting downward pressure on pricing. Price reductions have been common, thereby constraining profit margins for manufacturers and impacting revenue growth.

Regulatory Environment and Intellectual Property

Regulatory Developments

Since its original approval, BREVIBLOC has maintained a stable regulatory footprint. However, future approvals for additional indications or novel formulations could influence its market dynamics. Enhanced label expansions or usage guidelines can foster broader utilization.

Intellectual Property and Patent Status

Patent protections for esmolol have long expired, leaving manufacturing solely dependent on generic competition. Investments in formulation innovations or delivery systems could potentially provide differentiated products, though no recent patents have been granted in this domain.

Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Historical sales for BREVIBLOC have been relatively stable, with global revenues estimated at approximately $200-250 million annually in recent years [2]. The steady demand within hospital settings sustains the product, but growth prospects are limited by generic competition and regional regulatory variances.

Projected Growth Factors

• Market Penetration Expansion: Expansion into new geographic regions, especially emerging markets with rising surgical volumes, could offer moderate revenue increases.
• Indication Expansion: Evidence-based expansion into additional acute cardiovascular indications or new formulations (e.g., inhalation or sustained-release forms) may provide additional revenue streams.
• Pricing Pressure: Gross margins are likely to remain under downward pressure due to generic competition, necessitating cost optimization and portfolio diversification.

Forecast Outlook (2023-2028)

Analysts anticipate a compound annual growth rate (CAGR) of approximately 2-3% for BREVIBLOC’s revenue over the next five years, driven by incremental expansion in emerging markets and clinical practice adoption. However, growth potential remains constrained unless new indications or formulations are introduced.

Market Risks and Opportunities

Risks

• Intensified Competition: Increased adoption of agents like landiolol and other emerging IV beta-blockers could erode BREVIBLOC’s market share.
• Price Erosion: Ongoing generic competition is expected to keep prices under pressure.
• Regulatory Challenges: Restrictions or new safety regulations could impact usage patterns.
• Technological Innovation: Advances in non-pharmacologic perioperative management or alternative therapeutic modalities may diminish dependence on pharmacotherapy.

Opportunities

• Regional Penetration: Expanding sales efforts in Asia, Latin America, and emerging markets can unlock new revenue.
• Clinical Evidence and Trials: Supporting studies validating expanded indications could facilitate broader utilization.
• Combination Formulations: Developing fixed-dose combinations with other perioperative agents could enhance value propositions.

Strategic Considerations

• Market Positioning: Emphasizing BREVIBLOC’s rapid onset and short duration as key differentiators remains essential.
• Partnerships: Collaborations with regional distributors can accelerate penetration into underserved markets.
• Innovation: Investment in novel formulations or delivery mechanisms could mitigate generic price compression and confer competitive advantages.

Key Takeaways

• BREVIBLOC’s market is characterized by stability within hospital settings but faces limited growth due to generic competition.
• Emergence of newer, more selective agents like landiolol presents a significant competitive threat.
• Growth opportunities lie in expanding into emerging markets and exploring new clinical indications.
• Price erosion driven by generics constrains revenue growth; differentiation through innovation remains critical.
• Strategic investments in regional expansion, clinical validation, and formulation innovation can influence BREVIBLOC’s financial trajectory favorably.

Conclusion

BREVIBLOC remains a vital agent within acute cardiovascular management, but its future financial success hinges on strategic adaptation to healthcare dynamics. The evolving landscape demands focus on regional expansion, indication diversification, and technological innovation to sustain its market presence amid intensifying competition and pricing pressures.

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FAQs

Q1: What are the primary therapeutic uses of BREVIBLOC?
A1: BREVIBLOC is chiefly used for rapid control of heart rate and rhythm during or after surgery, particularly in managing tachycardia and supraventricular arrhythmias.

Q2: How does BREVIBLOC compare to newer beta-blockers like landiolol?
A2: While BREVIBLOC has a well-established efficacy profile, newer agents like landiolol offer higher beta-1 selectivity and ultra-short acting profiles, potentially reducing side effects and expanding applicability.

Q3: What market factors threaten BREVIBLOC’s future revenue growth?
A3: The primary threats include patent expirations leading to generic competition, emergence of alternative agents with superior profiles, and pricing pressures in hospital markets.

Q4: Are there any recent regulatory updates affecting BREVIBLOC?
A4: There have been no recent significant regulatory modifications; however, potential label expansions or indications could influence utilization patterns.

Q5: What strategies can manufacturers pursue to sustain BREVIBLOC's competitiveness?
A5: Strategies include regional market expansion, investing in clinical research for new indications, developing innovative formulations, and establishing strategic partnerships to enhance market reach.

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Sources:

[1] Global Market Insights. (2022). Cardiovascular Drugs Market Size.
[2] Company Sales Data. (2022). BREVIBLOC Revenue Estimates.