Esmolol hydrochloride - Generic Drug Details

What are the generic sources for esmolol hydrochloride and what is the scope of freedom to operate?

Esmolol hydrochloride is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esmolol hydrochloride has seven patent family members in seven countries.

There are five drug master file entries for esmolol hydrochloride. Twelve suppliers are listed for this compound.

Summary for esmolol hydrochloride

International Patents:	7
US Patents:	2
Tradenames:	6
Applicants:	11
NDAs:	13
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	112
Patent Applications:	1,094
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esmolol hydrochloride
What excipients (inactive ingredients) are in esmolol hydrochloride?	esmolol hydrochloride excipients list
DailyMed Link:	esmolol hydrochloride at DailyMed

Recent Clinical Trials for esmolol hydrochloride

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

Sponsor	Phase
Muhammad Haroon Anwar	Phase 4
Pakistan Institute of Medical Sciences	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 3

See all esmolol hydrochloride clinical trials

Pharmacology for esmolol hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for esmolol hydrochloride

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE

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 esmolol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016		RX	Yes	Yes	8,835,505		Y
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	214172-002	Dec 2, 2022	AP	RX	No	No
Mylan Labs Ltd	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	206608-001	Jun 8, 2018	AP	RX	No	No
Am Regent	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	201126-001	Feb 20, 2015		DISCN	No	No

Expired US Patents for esmolol hydrochloride

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	6,310,094*PED
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 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

International Patents for esmolol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2016515513	改良軟質プラスチック容器中のすぐに使用可能な共溶媒医薬組成物
World Intellectual Property Organization (WIPO)	2014143845
China	105263809	Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
Canada	2906031	COMPOSITION PHARMACEUTIQUE DE COSOLVANTS PRETE A L'UTILISATION DANS DES RECIPIENTS DE MATIERE PLASTIQUE FLEXIBLES MODIFIES (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER)

Esmolol Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

Esmolol hydrochloride, a short-acting beta-blocker, is widely used for managing various cardiovascular conditions, including supraventricular tachycardia, noncompensatory sinus tachycardia, and perioperative hypertension. The global market for esmolol hydrochloride is poised for significant growth, driven by several key factors.

Global Market Size and Growth Rate

The global esmolol hydrochloride market is estimated to expand at a compound annual growth rate (CAGR) of 3.5% to 4.8% from 2024 to 2030/2031. By 2030, the market size is projected to reach approximately $487.2 million[3][2].

Regional Market Dynamics

North America

North America currently dominates the esmolol hydrochloride market, driven by the increasing incidence of heart diseases and the presence of well-established healthcare infrastructure. The region is expected to grow at a CAGR of 2.2% from 2024 to 2031, with the United States, Canada, and Mexico contributing significantly to this growth[1][2].

Asia-Pacific

The Asia-Pacific region is anticipated to witness substantial growth, driven by rising healthcare expenditure, growing awareness of cardiovascular health, and an increase in lifestyle-related health issues. This region holds the majority market share and is expected to grow at a CAGR of 6.0% from 2024 to 2031[1][3].

Europe

Europe is another significant market for esmolol hydrochloride, with a CAGR of 2.5% from 2024 to 2031. The region's growth is fueled by advancements in critical care and anesthesiology, as well as the increasing geriatric population[1][2].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa are also growing markets, albeit at a slower pace. Latin America is expected to grow at a CAGR of 3.4%, while the Middle East & Africa will grow at a CAGR of 3.7% from 2024 to 2031[1].

Key Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases globally is a major driver of the esmolol hydrochloride market. As the population ages and lifestyle-related health issues rise, the demand for effective cardiovascular treatments is escalating[2][3].

Growing Number of Surgical Procedures

The rise in surgical procedures, particularly in perioperative settings, is boosting the demand for esmolol hydrochloride. Its rapid onset and short half-life make it ideal for acute heart rate control during surgeries[1][3].

Advancements in Healthcare Infrastructure

Heightened investments in healthcare infrastructure, especially in emerging economies, are enhancing access to advanced treatment options, including esmolol hydrochloride. Government initiatives to improve healthcare access and infrastructure further support market growth[3].

Regulatory Approvals and Expanded Indications

Regulatory approvals for expanded indications of esmolol hydrochloride have significantly contributed to market growth. The drug is now approved for broader applications, including perioperative hypertension and arrhythmia management in intensive care settings[3].

Competitive Landscape

The esmolol hydrochloride market is highly competitive, with key players such as Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Mylan N.V., and Aurobindo Pharma Ltd. These companies are adopting strategies like mergers and acquisitions, product launches, and geographical expansion to strengthen their market presence. Innovations in formulations and delivery systems, as well as collaborations with research institutions, are also driving market expansion[2].

End-Use Segmentation

Hospitals

Hospitals are the largest consumers of esmolol hydrochloride, using the drug extensively for managing tachycardia and high blood pressure during surgeries. The growing focus on patient safety and effective intraoperative control is boosting demand in hospital settings[1].

Clinics and Research Institutes

Clinics and research institutes also play a significant role in the market, particularly in the development and testing of new formulations and applications of esmolol hydrochloride[3].

Financial Trajectory

The financial trajectory of the esmolol hydrochloride market is positive, with steady growth anticipated over the forecast period. Here are some key financial highlights:

• Global Market Size: Expected to reach $487.2 million by 2030[3].
• CAGR: Ranging from 3.5% to 4.8% from 2024 to 2030/2031[2][3].
• Regional Growth: North America, Asia-Pacific, and Europe are expected to contribute significantly to the market's financial growth[1][2].

Challenges and Opportunities

Generic Competition

The presence of generic alternatives is a significant challenge for branded manufacturers, as it drives down prices and affects profitability. However, this competition also benefits healthcare systems and patients by making treatment options more accessible[1].

Innovation and Strategic Partnerships

Pharmaceutical companies are focusing on innovation and strategic partnerships to develop novel formulations and improve patient compliance. This approach is expected to drive product development and market expansion[2].

Key Takeaways

• The global esmolol hydrochloride market is driven by the rising prevalence of cardiovascular diseases and the growing demand for effective treatments.
• North America and Asia-Pacific are key regions driving market growth.
• Regulatory approvals for expanded indications and advancements in healthcare infrastructure are significant growth drivers.
• Hospitals are the largest consumers of esmolol hydrochloride.
• The market is expected to grow steadily, with a projected CAGR of 3.5% to 4.8% from 2024 to 2030/2031.

FAQs

1. What is the projected CAGR of the global esmolol hydrochloride market from 2024 to 2030/2031?

   • The projected CAGR ranges from 3.5% to 4.8% from 2024 to 2030/2031[2][3].

2. Which region dominates the esmolol hydrochloride market?

   • North America currently dominates the market, but the Asia-Pacific region is expected to witness substantial growth[1][2].

3. What are the key drivers of the esmolol hydrochloride market?

   • The rising prevalence of cardiovascular diseases, growing number of surgical procedures, and advancements in healthcare infrastructure are key drivers[2][3].

4. Who are the major players in the esmolol hydrochloride market?

   • Key players include Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Mylan N.V., and Aurobindo Pharma Ltd.[2].

5. What is the expected global market size of esmolol hydrochloride by 2030?

   • The global market size is estimated to reach approximately $487.2 million by 2030[3].

Cited Sources

1. Cognitive Market Research: Esmolol Hydrochloride Market Report 2024 (Global Edition)[1].
2. MarkWide Research: Esmolol Hydrochloride Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030[2].
3. IndustryARC: Esmolol Hydrochloride Market – Forecast(2024 - 2030)[3].