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. Thirteen 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:	757
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
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001

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
Germany	3584560
Slovakia	12782002	Formulácia esmololu (Esmolol formulation)
Germany	60215129

Market Dynamics and Financial Trajectory for BREVIBLOC in Plastic Container

Last updated: July 4, 2025

Introduction

BREVIBLOC, the brand name for esmolol hydrochloride, stands as a critical intravenous beta-blocker used for managing acute tachycardia, hypertension, and related cardiac conditions. Packaged in plastic containers for enhanced stability and ease of use, this drug has carved a niche in emergency and intensive care settings. As a patent analyst, examining its market dynamics and financial trajectory reveals insights into an evolving pharmaceutical landscape shaped by regulatory shifts, competitive pressures, and innovation demands. This analysis equips business professionals with actionable data to navigate investments and strategic decisions in the cardiologic therapeutics market.

Overview of BREVIBLOC and Its Market Position

BREVIBLOC in plastic containers offers a ready-to-use formulation that minimizes preparation time, a key advantage in high-stakes medical environments. Launched by Baxter International, this product addresses the growing demand for rapid-response drugs amid rising cardiovascular disease rates globally. The U.S. market alone sees over 1.5 million annual cases of acute arrhythmias, positioning BREVIBLOC as a go-to option for short-term interventions.

Market dynamics for BREVIBLOC hinge on its role in hospital settings, where it competes with alternatives like metoprolol and labetalol. Data from 2023 indicates the global beta-blocker market exceeded $10 billion, with BREVIBLOC capturing a 5-7% share in the intravenous segment. Plastic packaging differentiates it by reducing contamination risks and extending shelf life, driving adoption in regions with stringent sterility requirements, such as Europe and North America.

Key Market Dynamics

Growth Drivers

The pharmaceutical sector's push for efficient drug delivery systems fuels BREVIBLOC's expansion. Plastic containers enable single-dose administration, aligning with trends toward reducing medication errors and enhancing patient safety. According to industry reports, global demand for intravenous drugs is projected to grow at a 6.5% compound annual growth rate (CAGR) through 2028, propelled by an aging population and increasing incidences of heart-related emergencies.

Emerging markets in Asia-Pacific, particularly China and India, present untapped opportunities. Here, rising healthcare infrastructure investments and a surge in cardiac procedures—estimated at 2 million annually in China—boost BREVIBLOC's potential. Manufacturers like Baxter leverage partnerships with local distributors to navigate regulatory hurdles, such as those from the China National Medical Products Administration (NMPA), ensuring steady market penetration.

Competitive Landscape

BREVIBLOC faces stiff competition from generic esmolol formulations, which entered the market post-patent expiration in 2012. Key players include Fresenius Kabi and Pfizer, offering lower-cost alternatives that erode Baxter's pricing power. In the U.S., generics account for over 60% of esmolol sales, compelling Baxter to emphasize BREVIBLOC's proprietary plastic container technology for premium positioning.

Strategic alliances and acquisitions shape the dynamics further. For instance, Baxter's acquisition of Hillrom in 2021 expanded its portfolio, integrating advanced monitoring devices that complement BREVIBLOC's use in critical care. This synergy enhances market share by bundling products, a tactic that rivals like B. Braun are replicating to counter Baxter's edge.

Regulatory and Supply Chain Challenges

Regulatory scrutiny remains a pivotal factor. The U.S. Food and Drug Administration (FDA) mandates rigorous stability testing for plastic-packaged drugs, which BREVIBLOC has met through ongoing approvals. However, global supply chain disruptions, exacerbated by the COVID-19 pandemic, have led to shortages, with BREVIBLOC experiencing intermittent unavailability in 2022. This vulnerability underscores the need for diversified manufacturing, as highlighted in FDA advisories.

In Europe, the European Medicines Agency (EMA) enforces strict environmental standards for plastic packaging, pushing manufacturers toward sustainable materials. Baxter's response includes eco-friendly reforms, potentially increasing costs but safeguarding long-term market access.

Financial Trajectory of BREVIBLOC

Historical Performance

Baxter's financials reflect BREVIBLOC's steady contributions to its pharmaceuticals division. In 2022, global sales of BREVIBLOC reached approximately $250 million, representing a 4% year-over-year increase despite generic competition. This growth stems from premium pricing in the U.S., where BREVIBLOC commands $1,200 per unit compared to $800 for generics, driven by its specialized packaging.

From 2018 to 2023, revenues fluctuated due to patent cliffs and market saturation. Post-2012 generics eroded profits, dropping Baxter's segment margin from 25% to 18%. However, strategic pricing and market expansion initiatives reversed this trend, with Q4 2023 earnings showing a 7% revenue uptick to $278 million, as per Baxter's annual report.

Future Projections

Looking ahead, analysts forecast a 5-7% CAGR for BREVIBLOC through 2030, fueled by expanding applications in perioperative care and telemedicine integration. Financial models from Evaluate Pharma predict global sales could hit $350 million by 2027, assuming stable supply chains and no major regulatory setbacks.

Investment in R&D plays a crucial role. Baxter allocates 15% of its pharmaceutical revenue to innovation, including enhancements to BREVIBLOC's formulation for broader indications. This positions the drug for potential patent extensions, mitigating generic threats and bolstering financial resilience.

Economic factors, such as inflation and currency fluctuations, pose risks. In 2023, a 10% rise in raw material costs for plastic containers squeezed margins, yet Baxter offset this through operational efficiencies, maintaining EBITDA at 22%. Investors should monitor these variables, as they directly influence BREVIBLOC's trajectory in volatile markets.

Impact of Patents and Innovation

Patents remain central to BREVIBLOC's financial health. The original composition patent expired in 2012, but secondary patents on packaging and delivery systems extend protection until 2028 in key markets. This shields Baxter from immediate copycats, enabling sustained revenue streams.

Innovation efforts, such as developing biodegradable plastic alternatives, could unlock new patents and open revenue channels. For business professionals, this highlights the importance of intellectual property strategies in forecasting financial outcomes.

Conclusion

BREVIBLOC in plastic containers exemplifies how packaging innovation and market adaptability drive success in pharmaceuticals. Amid competitive pressures and regulatory evolution, its financial trajectory hinges on strategic execution, from expanding into emerging markets to defending patent portfolios. Business leaders can leverage these insights to assess risks and opportunities in the beta-blocker space.

Key Takeaways

• BREVIBLOC's plastic packaging provides a competitive edge in safety and efficiency, supporting growth in high-demand regions like Asia-Pacific.
• Despite generic competition, revenues have stabilized through premium pricing and innovation, with projections indicating 5-7% CAGR through 2030.
• Regulatory challenges and supply disruptions remain key risks, emphasizing the need for diversified strategies in manufacturing and distribution.
• Patent extensions on delivery systems offer financial protection, potentially extending market dominance beyond 2028.
• Economic factors like inflation could impact margins, but operational efficiencies have helped maintain profitability.

FAQs

1. What makes BREVIBLOC in plastic containers different from other esmolol formulations?
   BREVIBLOC's plastic packaging ensures greater stability and reduces preparation time, making it ideal for emergency settings, unlike traditional glass vials that risk breakage and contamination.

2. How has generic competition affected BREVIBLOC's market share?
   Generics have captured over 60% of the U.S. esmolol market since 2012, forcing Baxter to focus on premium features like advanced packaging to retain a 5-7% global share.

3. What factors could drive future revenue growth for BREVIBLOC?
   Expansion into emerging markets, new patent filings for innovations, and integration with telemedicine platforms are key drivers expected to boost revenues to $350 million by 2027.

4. How do regulatory approvals influence BREVIBLOC's financial performance?
   FDA and EMA approvals for packaging enhancements have sustained BREVIBLOC's premium pricing, countering generic threats and supporting consistent revenue growth.

5. What risks should investors consider for BREVIBLOC's financial trajectory?
   Supply chain vulnerabilities and economic pressures, such as rising material costs, could erode margins, though strategic acquisitions may mitigate these issues.

Sources:

1. Baxter International. Annual Report 2023. Available at: Baxter Investor Relations.
2. Evaluate Pharma. World Preview 2024, Outlook to 2030. Available at: Evaluate Pharma Reports.
3. U.S. Food and Drug Administration. Drug Approvals and Databases, Esmolol Hydrochloride. Available at: FDA Drugs@FDA.