ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Esmolol Hydrochloride In Plastic Container, and when can generic versions of Esmolol Hydrochloride In Plastic Container launch?

Esmolol Hydrochloride In Plastic Container is a drug marketed by Hq Spclt Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER 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 Esmolol Hydrochloride In Plastic Container

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

Summary for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

International Patents:	7
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	129
Patent Applications:	791
DailyMed Link:	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

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

Sponsor	Phase
Qianfoshan Hospital	NA
University Hospital, Limoges	PHASE4
Qianfoshan Hospital	PHASE4

See all ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

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

US Patents and Regulatory Information for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is protected by two US patents.

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	8,829,054		Y
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016		RX	Yes	Yes	8,835,505		Y

Expired US Patents for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016	6,310,094*PED
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-001	Apr 7, 2016	6,528,540*PED

International Patents for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

See the table below for patents covering ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1368019
South Korea	100889090
Czech Republic	20023825
Japan	5778384
European Patent Office	1368019	FORMULATION D'ESMOLOL (ESMOLOL FORMULATION)

Market Dynamics and Financial Trajectory for Esmolol Hydrochloride in Plastic Container

Last updated: July 28, 2025

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Introduction

Esmolol hydrochloride, an ultra-short-acting beta-1 selective adrenergic blocker, is predominantly employed in acute settings such as intraoperative tachyarrhythmias, hypertension, and cardiac surgeries. Its pharmaceutical formulation in plastic containers signifies a standardized approach for infusion administration, ensuring optimal stability, safety, and convenience. This detailed analysis explores the market environment, key drivers, challenges, and financial projections for Esmolol Hydrochloride in plastic containers, underpinning strategic decision-making for stakeholders.

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Market Overview

The global demand for Esmolol Hydrochloride is driven primarily by the expanding need for precise intraoperative cardiovascular management and critical care interventions. The centralization of its administration through plastic infusion containers reflects a broader trend towards portability, safety, and ease of administration in hospital environments.

The pharmaceutical form — Esmolol Hydrochloride in plastic containers — benefits from existing manufacturing and sterilization standards optimized for training hospital staff and ensuring drug stability. This formulation's implications for market penetration, particularly in developed health systems, underpin its continual growth prospects.

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Market Dynamics

1. Drivers of Market Growth

a. Rising Incidence of Cardiac and Emergency Surgeries

A surge in cardiovascular disease (CVD) globally amplifies the use of intraoperative beta-blockers like Esmolol. The World Health Organization reports CVD as the leading cause of mortality worldwide, reinforcing the need for effective perioperative hemodynamic control [1].

b. Growing Critical Care Infrastructure

Advancements in ICU facilities and increased access to critical care services support higher utilization rates of infusion medications. The shift towards standardized, single-use plastic infusion systems enhances safety, reduces infection risks, and accelerates adoption [2].

c. Preference for Precise and Rapid-Acting Medications

Esmolol's ultra-short half-life (~9 minutes) offers rapid titratability and control, making it ideal for intensive care and surgical settings. Its compatibility with pre-filled plastic containers simplifies dosing and reduces preparation time, further propelling its demand.

d. Regulatory Approvals and Expanded Indications

Recent approvals or off-label expansion for various acute cardiovascular conditions, along with guidelines favoring beta-blocker use in specific intraoperative scenarios, contribute to growth [3].

2. Challenges Restraining Market Expansion

a. Price Sensitivity and Cost Constraints

While effective, Esmolol Hydrochloride in plastic containers commands a premium over alternative beta-blockers, impeding widespread usage in cost-sensitive markets.

b. Competition from Alternatives

Emergence of newer agents with comparable efficacy or longer-duration formulations in different delivery systems could threaten market share.

c. Supply Chain and Manufacturing Limitations

Dependence on specific manufacturing standards for sterile plastic containers and sterilization processes may hinder production scalability, especially in emerging regions.

d. Patient Safety and Compatibility Concerns

Potential incompatibilities with certain infusion systems and concerns over plastic leaching influence provider preference and usage protocols.

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Market Segmentation and Regional Insights

By Route of Administration: Intravenous infusion remains dominant, with plastic containers serving as the primary vehicle for drug delivery.

By Application: Surgical procedures, emergency cardiovascular care, and critical care units are the primary application zones.

Regional Dynamics:

• North America: Leads the market due to high healthcare expenditure, robust critical care infrastructure, and regulatory support.

• Europe: Elevated adoption influenced by stringent safety standards and comprehensive cardiovascular care protocols.

• Asia-Pacific: Rapidly growing market propelled by increasing cardiovascular incidence, expanding medical infrastructure, and rising healthcare investments, though challenges in manufacturing standards persist.

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Financial Trajectory and Market Forecast

1. Current Market Valuation

According to industry reports, the global market for Esmolol Hydrochloride formulations, including those in plastic containers, was valued at approximately $120 million in 2022 [4]. The plastic container segment accounts for an estimated 65-70% of this market, driven by safety and operational efficiencies.

2. Growth Projections (2023–2028)

With a compound annual growth rate (CAGR) of around 6.5-8%, the market is projected to reach $180–$200 million by 2028. Key factors influencing this growth include:

• Continuous adoption in evolving healthcare systems.
• Introduction of pre-filled, ready-to-use plastic infusion systems.
• Emergence of cost-effective manufacturing solutions to penetrate emerging markets.

3. Revenue Streams and Profitability

The revenue model largely depends on volume sales driven by hospital procurement contracts, infusion set integration, and institutional formularies. Margins are influenced by raw material costs (plastics, sterilization), regulatory compliance expenses, and competitive pricing strategies.

Innovations such as smart infusion devices compatible with Esmolol in plastic containers could open higher-margin avenues, integrating digital health solutions with traditional drug delivery.

4. Potential Future Trends Impacting Financials

• Market Penetration into Emerging Economies: Growing infrastructure can expand demand, potentially doubling sales volumes.
• Regulatory Trends: Streamlined approval processes for generic equivalents can intensify competition and compress margins.
• Technological Innovations: Development of recyclable or biodegradable plastic containers may enhance marketability and reduce environmental compliance costs.

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Conclusion

The market for Esmolol Hydrochloride in plastic containers demonstrates a resilient growth trajectory fueled by the escalating global burden of cardiovascular disease and critical care requirements. While challenges such as cost sensitivity and competition loom, strategic investments in manufacturing efficiencies, regulatory navigation, and technological integration promise sustainable financial expansion.

Key to success will be aligning product development with evolving hospital procurement preferences, leveraging safety and convenience benefits inherent to plastic infusion systems, and expanding access into emerging markets.

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Key Takeaways

• The global Esmolol Hydrochloride market is projected to grow at a CAGR of approximately 7% through 2028.
• The plastic container formulation enhances safety, convenience, and compliance, driving adoption among hospitals.
• Market growth is primarily driven by rising cardiovascular surgeries, critical care needs, and technological advancements.
• Price competition and alternative therapies pose ongoing market challenges, requiring strategic differentiation.
• Emerging markets present significant growth opportunities if manufacturing and regulatory hurdles are addressed effectively.

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FAQs

1. What are the primary clinical benefits of Esmolol Hydrochloride in plastic containers?
   The pre-filled plastic containers facilitate rapid, safe, and standardized infusion administration, enabling precise intraoperative and critical care management with minimal preparation time.

2. How does the formulation in plastic containers impact storage and stability?
   Plastic infusion containers are designed to maintain drug stability, prevent contamination, and are compatible with standard hospital infusion systems, extending shelf life and ensuring safety.

3. What are the main challenges facing the commercialization of Esmolol Hydrochloride in plastic containers?
   Challenges include high manufacturing costs, supply chain complexities, competition from alternative agents, and regulatory hurdles in various regions.

4. Which regions hold the highest growth potential for this drug formulation?
   North America and Europe currently dominate, but Asia-Pacific and Latin America offer significant future growth due to expanding healthcare infrastructure and rising cardiovascular disease prevalence.

5. How might technological innovations influence future market dynamics?
   Integration of smart infusion systems, recyclable plastics, and biodegradable containers can enhance safety profiles, environmental compliance, and market attractiveness, fostering new revenue streams.

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References

[1] World Health Organization. Cardiovascular Diseases Fact Sheet. 2022.

[2] Bouchard, J.P., et al. "Advances in Infusion Technology for Critical Care," Critical Care Medicine, 2021.

[3] Regulatory Authority Announcements. "Esmolol Hydrochloride Approvals and Usage Guidelines," 2022.

[4] Market Research Future. "Global Pharmaceutical Infusion Market Trends," 2023.