ESMOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for esmolol hydrochloride and what is the scope of patent protection?

Esmolol hydrochloride is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland, 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. Fourteen 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:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	129
Patent Applications:	1,184
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
Qianfoshan Hospital	NA
University Hospital, Limoges	PHASE4
Qianfoshan Hospital	PHASE4

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
Fresenius Kabi Usa	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	076573-001	May 2, 2005		DISCN	No	No
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	214172-002	Dec 2, 2022	AP	RX	No	No
Mylan Institutional	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	076474-001	May 2, 2005	AP	RX	No	No

Expired US Patents for ESMOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016

International Patents for ESMOLOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	105263809	Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
European Patent Office	2948379	COMPOSITION PHARMACEUTIQUE DE COSOLVANTS PRÊTE À L'UTILISATION DANS DES RÉCIPIENTS DE MATIÈRE PLASTIQUE FLEXIBLES MODIFIÉS (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER)
World Intellectual Property Organization (WIPO)	2014143845

Market Dynamics and Financial Trajectory for Esmolol Hydrochloride

Last updated: July 27, 2025

Introduction

Esmolol hydrochloride is a high-selectivity beta-1 adrenergic receptor antagonist primarily used for rapid control of ventricular rate in atrial fibrillation and flutter, as well as intraoperative and postoperative hypertension management. With its ultra-short action profile, esmolol presents unique opportunities within acute care settings. This analysis explores market dynamics, competitive landscape, regulatory influences, and financial projections shaping the trajectory of esmolol hydrochloride.

Market Overview

The global beta-blocker market, encompassing esmolol, was valued at approximately USD 11.8 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.2% through 2028 [1]. Esmolol’s niche application for rapid hemodynamic control positions it distinctly within the acute care therapeutics segment, with distinctive advantages such as quick onset and short duration.

The demand for esmolol primarily stems from critical care and surgical settings. The increasing prevalence of cardiovascular diseases (CVDs), including atrial fibrillation, hypertension, and ischemic heart conditions, fuels the need for rapid-acting beta-blockers [2]. Furthermore, expanding usage in anesthesia and emergency medicine enhances the growth prospects for esmolol.

Market Drivers

1. Rising Prevalence of Cardiovascular Diseases:
CVDs remain the leading cause of death globally, with an estimated 17.9 million deaths annually [3]. Heart rhythm disorders such as atrial fibrillation, which require acute rate control, significantly bolster esmolol’s demand. Aging populations in North America, Europe, and parts of Asia further accelerate this trend.

2. Expanding Emergency and Critical Care Facilities:
Growth in hospital and intensive care unit (ICU) capacities fuels the utilization of rapid-onset agents like esmolol. Emergency protocols increasingly favor agents with rapid titratability, favoring esmolol’s profile.

3. Advances in Surgical and Anesthesia Practices:
Esmolol’s short half-life (around 9 minutes) makes it ideal for intraoperative control, especially in cardiac surgeries and procedures requiring precise hemodynamic management. Enhanced surgical safety protocols bolster demand.

4. Technological and Formulation Innovations:
Recent developments include stable formulations amenable to various delivery systems, potentially expanding usage scope. Additionally, the development of biosimilar or generic versions can enhance accessibility and volume.

Market Constraints

1. Competitive Landscape:
Esmolol faces competition from other beta-blockers like metoprolol and labetalol, which, although less rapid in action, are widely available and cost-effective. The market dominance of established, generic beta-blockers constrains esmolol’s premium positioning.

2. Regulatory and Pricing Challenges:
Stringent approval processes, especially for new formulations or delivery methods, could delay market expansion. Price sensitivity in healthcare systems, especially in developing regions, limits potential margins.

3. Limited Indications and Usage Profile:
Esmolol’s niche application limits its market size, confined mainly to acute care settings. Long-term cardiovascular management predominantly relies on other beta-blockers with chronic use profiles.

Regulatory Environment

Esmolol is approved by major regulatory bodies such as the FDA and EMA, primarily for intravenous use in perioperative and emergency settings. Its regulatory pathway has been well-established, but any new formulations or indications would require additional approval. Price controls and reimbursement policies further influence market penetration, especially in publicly funded healthcare systems.

Competitive Players

• Baxter International: A leading provider offering esmolol formulations, with a significant presence in North America and Europe.
• Pfizer and Novartis: Historically involved through licensing and supply agreements, with some diversification into related beta-blocker markets.
• Generic manufacturers: Increasingly entering markets within emerging economies, leveraging cost advantages.

Financial Trajectory and Forecast

Given the niche focus but expanding critical care and surgical markets, esmolol’s revenue trajectory is expected to be steady but modest. Projections suggest the following:

• 2023–2028 CAGR: 3-4%, aligned with overall beta-blocker market growth but tempered by its specialized application.
• Revenue Estimates:
  • 2023: USD 250 million
  • 2028: USD 310 million

This moderate growth reflects incremental market expansion driven by aging populations and healthcare infrastructure development in emerging markets, offset by the competitive presence of cost-effective alternatives.

Emerging Opportunities

• Development of Biosimilar Versions: Lower-cost biosimilars could expand access in low- and middle-income countries, increasing volume.
• New Indications: Investigations into esmolol’s utility in acute neurocritical care or as part of combination therapies could broaden applications.
• Formulation Innovation: Long-acting or inhalable formulations might open new therapeutic pathways, enhancing revenue streams.

Risks and Uncertainties

• Regulatory Delays: Delays in approval for new formulations or indications could constrain growth.
• Market Penetration Challenges: Limited exclusivity and patent expirations could intensify generic competition.
• Economic Fluctuations: Healthcare budget pressures, especially post-pandemic, could restrict procurement and reimbursement.

Key Takeaways

• Steady Market Niche: Esmolol hydrochloride occupies a specialized position within acute cardiovascular care, with steady demand growth aligned with broader healthcare trends.
• Growth Drivers: Rising CVD prevalence, expanding critical care infrastructure, and surgical innovations sustain its market trajectory.
• Competitive Dynamics: Dominance by generic manufacturers and established beta-blockers constrains premium pricing but offers opportunities for volume expansion through biosimilars.
• Strategic Opportunities: Investment in new formulations and indications could unlock further revenue streams amid typical market saturation.
• Market Risks: Regulatory hurdles, pricing pressures, and inherent niche limitations necessitate strategic agility.

Conclusion

Esmolol hydrochloride exhibits a resilient yet moderate growth profile driven by its unique pharmacokinetics and expanding clinical utility. While competition and market constraints temper its expansion potential, ongoing medical and technological advances present avenues for sustained financial performance. Stakeholders should focus on innovation, market access strategies, and leveraging emerging global healthcare trends to maximize the drug’s commercial trajectory.

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FAQs

1. What are the main clinical advantages of esmolol over other beta-blockers?
Esmolol offers rapid onset and offset of action due to its ultra-short half-life, making it ideal for acute, short-term control of heart rate during surgeries or emergencies.

2. How does the competitive landscape influence esmolol’s market growth?
The presence of generic beta-blockers with broader indications and lower prices limits esmolol’s market share, confining its use primarily to specialized acute care settings.

3. Are there ongoing developments to expand esmolol’s indications?
Research into novel applications, such as in neurocritical care or combination therapies, is ongoing but not yet standard clinical practice or approved indications.

4. What regional factors affect esmolol’s market potential?
Developed markets with advanced critical care facilities drive demand, whereas pricing pressures and regulatory barriers in emerging economies can hinder expansion.

5. How might biosimilars impact esmolol’s future revenue?
Introduction of biosimilars could decrease prices and expand access, especially in cost-sensitive markets, potentially increasing volume but reducing margins.

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Sources

[1] MarketWatch, "Beta-Blockers Market Size, Share & Trends Analysis," 2022.
[2] World Health Organization, "Cardiovascular Diseases Fact Sheet," 2021.
[3] Global Burden of Disease Study, "Global Data on Cardiovascular Disease Prevalence," 2020.