BREVIBLOC IN PLASTIC CONTAINER Drug Patent Profile

When do Brevibloc In Plastic Container patents expire, and when can generic versions of Brevibloc In Plastic Container launch?

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

The generic ingredient in BREVIBLOC IN PLASTIC CONTAINER 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 In Plastic Container

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

Summary for BREVIBLOC IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	16
Patent Applications:	732
DailyMed Link:	BREVIBLOC IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for BREVIBLOC IN PLASTIC CONTAINER

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 IN PLASTIC CONTAINER clinical trials

Pharmacology for BREVIBLOC IN PLASTIC CONTAINER

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

Paragraph IV (Patent) Challenges for BREVIBLOC IN PLASTIC CONTAINER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREVIBLOC IN PLASTIC CONTAINER	Injection	esmolol hydrochloride	10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags	019386	1	2014-01-31

US Patents and Regulatory Information for BREVIBLOC IN PLASTIC CONTAINER

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 IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	AP	RX	Yes	Yes

Expired US Patents for BREVIBLOC IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	4,593,119*PED
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	6,528,540*PED
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	6,310,094*PED

International Patents for BREVIBLOC IN PLASTIC CONTAINER

See the table below for patents covering BREVIBLOC IN PLASTIC CONTAINER 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 IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BREVIBLOC (Esmolol Hydrochloride) in Plastic Containers

Market Overview

The market for Esmolol Hydrochloride, marketed under the brand name BREVIBLOC among others, is experiencing significant growth driven by several key factors. Here are the key dynamics and financial projections for this market.

Growing Incidence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases such as hypertension, arrhythmias, and tachycardia is a major driver of the Esmolol Hydrochloride market. As these conditions become more common globally, there is a rising demand for effective treatment options, particularly for acute heart rate control[4].

Clinical Indications and Usage

Esmolol Hydrochloride is widely used for the short-term treatment of supraventricular tachycardia, non-compensatory sinus tachycardia, intraoperative and postoperative tachycardia, and perioperative hypertension. Its rapid onset and short half-life make it ideal for acute care settings, especially in perioperative scenarios[1][3][5].

Geographical Segmentation

• Asia-Pacific (APAC): This region dominates the market, 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 also support market growth in APAC[1].
• North America: This region is also a significant market, driven by rising cardiovascular disease incidence, an increase in surgical procedures, and the presence of established healthcare infrastructure. The availability of both branded and generic formulations contributes to market growth in North America[4].

Market Size and Growth Projections

• The global Esmolol Hydrochloride market is estimated to reach $487.2 million by 2030, growing at a CAGR of 3.5% during the forecast period of 2024-2030[1].
• Another report projects the market to expand at a CAGR of 4.0% from 2024 to 2031, with the Asia-Pacific region expected to grow at a CAGR of 6.0% during this period[4].

Regulatory Approvals and Expanding Indications

Regulatory approvals for expanded indications have significantly contributed to market growth. Esmolol Hydrochloride is now approved for broader applications, including perioperative hypertension and arrhythmia management in intensive care settings. These expanded indications have increased adoption in hospitals and clinics, particularly in high-stakes medical environments[1].

Pharmaceutical Innovations and Generic Entries

The market has seen the entry of generic versions of Esmolol Hydrochloride, such as Mylan's launch of the first generic version of Brevibloc in single-dose plastic bags. This has increased market accessibility and reduced costs, making the drug more available to patients[3].

Sales Channels and End Use

The drug is distributed through various channels, including distributors, pharmaceutical companies, and online platforms. Hospitals, clinics, and research institutes are the primary end-users, with growing demand driven by the need for effective and rapid heart rate control in these settings[1].

Financial Trajectory

• The financial trajectory of the Esmolol Hydrochloride market is positive, with steady growth expected over the forecast period. The market's expansion is supported by increased healthcare investments, particularly in emerging economies, and the growing adoption of beta-blockers in critical care[1].
• Companies like Cardiome Pharma Corp. are also contributing to the growth through strategic partnerships and the commercialization of Esmolol Hydrochloride in various regions. Cardiome's focus on developing and commercializing cardiovascular and infectious disease medicines adds to the market's financial stability[2].

Key Trends Shaping the Market

• Heightened Investments in Healthcare Infrastructure: Especially in emerging economies, investments in healthcare infrastructure are driving the demand for advanced treatment options like Esmolol Hydrochloride[1].
• Integration of Telemedicine and Digital Health Monitoring: The integration of telemedicine and digital health monitoring in cardiac care is driving early detection and intervention, emphasizing the need for rapid-onset treatments like Esmolol Hydrochloride[1].

Pharmacokinetics and Clinical Significance

Esmolol Hydrochloride's pharmacokinetic profile, including its rapid distribution half-life of about 2 minutes and elimination half-life of about 9 minutes, makes it highly effective for acute heart rate control. Its metabolism by red blood cell esterases ensures rapid onset and offset of action, which is crucial in critical care settings[5].

Market Competition and Generic Market

The entry of generic versions, such as Mylan's Esmolol Hydrochloride in Sodium Chloride Injection, has increased competition in the market. However, the branded version, BREVIBLOC, remains a significant player due to its established reputation and clinical efficacy[3].

Regional Growth and Market Share

• Asia-Pacific: Holds the majority market share, driven by high prevalence of cardiovascular disorders and increasing healthcare access[1].
• North America: Expected to have significant growth due to rising cardiovascular disease incidence and established healthcare infrastructure[4].
• Latin America and Middle East & Africa: These regions also show growth potential, albeit at a slower CAGR compared to APAC and North America[4].

Key Takeaways

• The Esmolol Hydrochloride market is driven by rising cardiovascular disease incidence, increased surgical procedures, and advancements in critical care.
• Regulatory approvals for expanded indications and the integration of telemedicine are key growth drivers.
• Asia-Pacific dominates the market, with North America also showing significant growth.
• Generic entries and pharmaceutical innovations are increasing market accessibility.

FAQs

1. What are the primary indications for Esmolol Hydrochloride?

Esmolol Hydrochloride is primarily used for the short-term treatment of supraventricular tachycardia, non-compensatory sinus tachycardia, intraoperative and postoperative tachycardia, and perioperative hypertension[1][3][5].

2. Which region dominates the Esmolol Hydrochloride market?

The Asia-Pacific region currently dominates the Esmolol Hydrochloride market, driven by a high prevalence of cardiovascular disorders and increasing healthcare access[1].

3. What is the projected market size of Esmolol Hydrochloride by 2030?

The global Esmolol Hydrochloride market is estimated to reach $487.2 million by 2030, growing at a CAGR of 3.5% during the forecast period of 2024-2030[1].

4. How does the pharmacokinetic profile of Esmolol Hydrochloride contribute to its clinical efficacy?

Esmolol Hydrochloride's rapid distribution half-life and elimination half-life, along with its metabolism by red blood cell esterases, ensure rapid onset and offset of action, making it highly effective for acute heart rate control[5].

5. What role do generic versions play in the Esmolol Hydrochloride market?

Generic versions, such as Mylan's Esmolol Hydrochloride in Sodium Chloride Injection, increase market competition and accessibility, reducing costs and making the drug more available to patients[3].

Cited Sources:

1. IndustryARC, "Esmolol Hydrochloride Market - Forecast(2024 - 2030)", December 6, 2024.
2. Zacks Small-Cap Research, "Cardiome Pharma Corp.", January 29, 2018.
3. Mylan, "Mylan Adds to Cardiovascular Portfolio With Launch of First Generic of Brevibloc® Injection in Single-Dose Bags", September 13, 2018.
4. Cognitive Market Research, "Esmolol Hydrochloride Market Report 2024 (Global Edition)", October 28, 2024.
5. FDA, "BREVIBLOC Premixed Injection", 2007.