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. Twelve 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:	96
Clinical Trials:	16
Patent Applications:	732
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
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003		DISCN	No	No
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	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	019386-006	Feb 25, 2003	6,310,094*PED
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003	6,528,540*PED
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988	4,387,103
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003	4,593,119*PED
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003	6,528,540*PED

International Patents for BREVIBLOC

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

Country	Patent Number	Title	Estimated Expiration
Greece	76921
Japan	2013151572	ESMOLOL FORMULATION
Argentina	098013	UNA COMPOSICIÓN FARMACÉUTICA ACUOSA ESTÉRIL, LISTA PARA SU USO, ADECUADA PARA LA ADMINISTRACIÓN PARENTERAL, MEDIANTE INFUSIÓN PARA EL TRATAMIENTO DE CONDICIONES CARDÍACAS, ENVASADA EN UN RECIPIENTE SELLADO, Y QUE POSEE UN pH ENTRE 3,5 Y 6,5, Y MÉTODO PARA SU FABRICACIÓN
Italy	8547927
Japan	2004519506

BREVIBLOC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brevibloc (Esmolol Hydrochloride)

Market Overview

Brevibloc, known generically as esmolol hydrochloride, is a cardio-selective beta-blocker widely used for its rapid onset and short half-life, making it ideal for acute heart rate control, particularly in perioperative settings. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Growing Demand for Cardiovascular Treatments

The global esmolol hydrochloride market is driven by the rising incidence of cardiovascular diseases, including hypertension and arrhythmias. As these conditions become more common globally, there is an increasing need for effective treatment options. Esmolol, with its quick-acting properties, is in high demand for treating acute conditions such as tachycardia and hypertension during surgeries[4].

Market Size and Growth

The esmolol hydrochloride market is projected to reach $487.2 million by 2030, growing at a compound annual growth rate (CAGR) of 3.5% from 2024 to 2030. Another report suggests a slightly higher CAGR of 4.0% from 2024 to 2031, indicating a steady and significant growth trajectory[1][4].

Geographical Segmentation

Asia-Pacific (APAC) Dominance

The APAC region holds the majority market share, driven by a high prevalence of cardiovascular disorders, increasing lifestyle-related health issues, and expanding geriatric populations in countries like China, India, and Japan. Government initiatives to improve healthcare access and infrastructure, especially in rural areas, further support market growth in this region[1].

North America

North America is also a significant market, driven by rising cardiovascular disorder occurrences, an increase in surgical procedures, and heightened recognition of effective treatment options. The presence of established healthcare infrastructure and the availability of both branded and generic formulations contribute to market growth in this region[4].

Other Regions

Latin America and the Middle East and Africa hold smaller but growing market shares, with CAGRs of 3.4% and 3.7%, respectively, from 2024 to 2031. These regions are also seeing increased demand due to growing cardiovascular disease rates and improving healthcare access[4].

Key Indications and Applications

Supraventricular Tachycardia and Noncompensatory Sinus Tachycardia

These conditions are expected to dominate the esmolol hydrochloride market over the forecast period. The rising incidence of these arrhythmias drives the demand for esmolol, known for its rapid-acting properties[4].

Intraoperative and Postoperative Tachycardia

The growing occurrence of intraoperative and postoperative tachycardia is propelling the esmolol hydrochloride market. Healthcare professionals prioritize effective management of heart rate fluctuations during and after surgical procedures, making esmolol a favored choice[4].

Perioperative Hypertension

Esmolol hydrochloride is increasingly approved for broader applications, including perioperative hypertension and arrhythmia management in intensive care settings. Its fast onset and short half-life make it essential in high-stakes medical environments where swift heart rate management is crucial[1].

Regulatory Approvals and Expanding Indications

Regulatory approvals for expanded indications of esmolol hydrochloride have significantly contributed to market growth. Originally used primarily for short-term heart rate control, esmolol hydrochloride is now approved for broader applications, enhancing its adoption in hospitals and clinics worldwide. Accelerated approvals in emerging markets are making the drug more accessible, fueling growth in both developed and developing regions[1].

Impact of COVID-19

The COVID-19 pandemic had a temporary impact on the esmolol hydrochloride market due to disruptions in healthcare services and adjustments in surgical methods. However, the increased awareness of cardiovascular health and the management of complications arising from COVID-19 patients revived interest in esmolol. As healthcare systems recover, the market is expected to regain momentum, driven by renewed surgical activities[4].

Pharmaceutical Innovations and Delivery Systems

The demand for fast-acting, short-duration beta-blockers has spurred pharmaceutical innovation, resulting in improved formulations and delivery systems. This innovation is driving market growth by providing healthcare providers with more effective and convenient treatment options[1].

Financial Performance and Projections

Revenue Growth

The esmolol hydrochloride market is expected to grow steadily, with projected revenues reaching $487.2 million by 2030. This growth is driven by increasing demand, regulatory approvals, and advancements in healthcare infrastructure, particularly in emerging economies[1].

Key Players and Market Strategies

Companies like Cardiome Pharma Corp. are playing a significant role in the market by focusing on developing and commercializing esmolol hydrochloride and other cardiovascular medicines. Cardiome's strategy includes seeking pharmaceutical partners for global distribution outside the US, which helps in expanding the market reach of esmolol hydrochloride[2].

Market Accessibility and Availability

Clinics and Outpatient Procedures

Clinics are increasingly contributing to the growth of the esmolol hydrochloride market as they adopt the drug for outpatient procedures and cardiac management. The growing occurrence of cardiovascular conditions and the need for effective treatment alternatives in non-hospital settings enhance esmolol's usage and availability[4].

Telemedicine and Digital Health

The integration of telemedicine and digital health monitoring in cardiac care is driving demand for esmolol hydrochloride. These technologies promote early detection and intervention, emphasizing the need for rapid-onset treatments like esmolol[1].

Key Takeaways

• Rising Incidence of Cardiovascular Diseases: The growing incidence of cardiovascular illnesses is a primary driver of the esmolol hydrochloride market.
• Regulatory Approvals: Expanded indications and regulatory approvals are significantly contributing to market growth.
• Geographical Growth: APAC and North America are key regions driving market growth, with other regions also showing significant potential.
• Pharmaceutical Innovations: Improved formulations and delivery systems are enhancing market accessibility and effectiveness.
• COVID-19 Impact: Despite temporary disruptions, the market is expected to regain momentum as healthcare systems recover.

FAQs

What is the projected market size of esmolol hydrochloride by 2030?

The esmolol hydrochloride market is estimated to reach $487.2 million by 2030, growing at a CAGR of 3.5% from 2024 to 2030[1].

Which region dominates the esmolol hydrochloride market?

The Asia-Pacific (APAC) region holds the majority market share, driven by a high prevalence of cardiovascular disorders and expanding geriatric populations[1].

What are the key indications driving the demand for esmolol hydrochloride?

Supraventricular tachycardia, noncompensatory sinus tachycardia, intraoperative and postoperative tachycardia, and perioperative hypertension are the key indications driving the demand for esmolol hydrochloride[4].

How has the COVID-19 pandemic impacted the esmolol hydrochloride market?

The COVID-19 pandemic caused temporary disruptions in healthcare services and surgical methods, but the market is expected to regain momentum as healthcare systems recover and awareness of cardiovascular health increases[4].

What role do regulatory approvals play in the market growth of esmolol hydrochloride?

Regulatory approvals for expanded indications have significantly contributed to market growth by enhancing the adoption of esmolol hydrochloride in hospitals and clinics worldwide[1].

Sources

1. IndustryARC: "Esmolol Hydrochloride Market - Forecast(2024 - 2030)"[1]
2. Zacks Small-Cap Research: "Cardiome Pharma Corp."[2]
3. Milestone Pharmaceuticals, Inc.: "FDA Regulations"[3]
4. Cognitive Market Research: "Esmolol Hydrochloride Market Report 2024 (Global Edition)"[4]
5. FDA: "BREVIBLOC Premixed Injection Label"[5]