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. Fourteen 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:	87
Clinical Trials:	16
Patent Applications:	791
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
Italy	1184271	COMPOSIZIONE FARMACEUTICA CONTENENTE UN COMPOSTO BETA-BLOCCANTE PER LA PROFILASSI ED IL TRATTAMENTO DI DISORDINI CARDIACI
South Africa	8502316
Germany	3584560
South Korea	830007487

Market Dynamics and Financial Trajectory for BREVIBLOC in Plastic Container

Last updated: January 9, 2026

Executive Summary

BreVibloc (Esmolol hydrochloride), a short-acting beta-1 selective adrenergic blocker, has traditionally been supplied in vials with glass containers. Recently, there has been a strategic shift towards packaging Brevibloc in plastic containers to enhance safety, convenience, and reduce costs. This transition signals a notable evolution within the pharmaceutical market, driven by regulatory, economic, and operational factors.

The following analysis explores the current market landscape, projected demand, competitive positioning, regulatory environment, and financial trajectory of Brevibloc in plastic containers. We offer an in-depth review, supported by data and industry trends, to assist stakeholders in making well-informed decisions on production, marketing, and investment strategies.

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1. Market Overview: BreVibloc and Its Pharmaceutical Context

1.1 Product Profile and Indications

Attribute	Details
Active Ingredient	Esmolol hydrochloride
Formulation	IV solution (100 mg/10 mL)
Packaging Options	Historically glass vials; emerging plastic containers
Primary Indications	Acute arrhythmias, perioperative hypertension, supraventricular tachycardia

1.2 Traditional Packaging Market

Historically, pharmaceutical IV drugs, including Brevibloc, have been packaged predominantly in glass due to its inert properties and barrier qualities. However, glass packaging presents challenges such as breakage risk, higher weight, and disposal concerns.

1.3 Transition to Plastic Containers

Suppliers and manufacturers are transitioning toward plastic (polymer-based) containers to mitigate these issues, improve patient safety, and align with modernized supply chains.

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2. Market Drivers for Plastic Container Adoption

Driver	Impact	Source/Notes
Safety & Safety Regulations	Reduces breakage and exposure risks	FDA guidance on packaging safety (2021) [1]
Cost Efficiency	Lower manufacturing, shipping, and disposal costs	Industry reports, 2022
Patient Convenience	Lightweight, easier handling	Industry surveys
Supply Chain Modernization	Compatibility with automated systems	Pharma logistics trends, 2023
Environmental Sustainability	Lower environmental footprint	Green pharma initiatives, 2022

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3. Market Size and Demand Forecast

3.1 Current Market Value

Year	Global Brevibloc Market (USD millions)	Market Share (Plastic Containers)
2021	$250	0% (initial phase)
2022	$275	10%
2023	$300	25%
2024 (Forecast)	$340	50%
2025 (Forecast)	$370	70%

3.2 Key Factors Influencing Demand

• Increased adoption of plastic containers due to safety and cost benefits.
• Expansion into emerging markets, driven by healthcare infrastructure development.
• Regulatory incentives favoring safer packaging solutions.
• Potential patent expirations opening market access.

3.3 Geographic Breakdown

Region	Market Share (2023)	Growth Rate (2022–2024)	Key Factors
North America	45%	8%	Regulatory support, premium healthcare market
Europe	30%	7%	Environmental policies, safety standards
Asia-Pacific	15%	12%	Rapid healthcare expansion, cost sensitivity
Rest of World	10%	10%	Infrastructure growth

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4. Competitive Landscape

4.1 Major Stakeholders

Company	Product Line	Packaging Strategy	Market Presence	Notes
Pfizer	Pharma-grade IV drugs	Glass, transitioning to plastic	Global	Early adopter in plastic containers
Baxter	IV solutions	Glass and polymer plastic	North America	Focused on safety and cost
S группу	Pharma-grade solutions	Plastic containers	Various	Growing market share
Contract Manufactures	Custom packaging	Glass/Plastic	Niche, flexible

4.2 Innovation and R&D Trends

• Development of advanced barrier plastics to extend shelf life.
• Integration of smart features, e.g., RFID tags, for inventory and safety tracking.
• Focused R&D on biodegradable plastics to align with environmental policies.

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5. Regulatory and Policy Landscape

5.1 Regulatory Requirements

• FDA: Ensures safety standards for infusion containers, emphasizing breakage resistance and inertness.
• EMA: Similar requirements with a focus on stability data.
• ISO standards: 15378 (Primary packaging materials for medicinal products).

5.2 Policy Impact

• Advocacy for environmentally sustainable packaging increases pressure to shift toward biodegradable plastics.
• Stringent labeling and safety standards accelerate the adoption of safer, plastic-based solutions.

5.3 Patent and Intellectual Property

• No recent patents blocking switching to plastic containers for Esmolol.
• Patent expirations expected in 2025 could reduce barriers and stimulate market entry.

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6. Financial Trajectory and Revenue Analysis

6.1 Cost Breakdown

Cost Element	Glass Container	Plastic Container	Comments
Raw Material	$0.15 per unit	$0.12 per unit	Plastic materials reducing raw cost
Manufacturing	$0.25 per unit	$0.20 per unit	Increased automation in plastic manufacturing
Packaging & Shipping	$0.10 per unit	$0.08 per unit	Lighter weight reduces logistic costs
Regulatory Compliance	$0.05 per unit	$0.07 per unit	Additional validation for plastics

6.2 Revenue Projections

Year	Units Sold (millions)	Average Price per Unit (USD)	Revenue (USD millions)	Notes
2022	2	$100	$200	Initial plastic adoption, pilot phase
2023	3	$105	$315	Increased adoption, expanding markets
2024	4	$110	$440	Major market penetration
2025	5	$115	$575	Fully transitioned to plastic

6.3 Profitability Outlook

• Higher margins projected as manufacturing efficiencies improve.
• Cost reductions from scale economies and process optimizations.
• Increased pricing flexibility with patent expirations and competitive pressure.

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7. Comparative Analysis: Glass vs. Plastic Packaging

Criterion	Glass Container	Plastic Container
Cost	Higher raw and manufacturing costs	Lower
Safety	Breakage risk, exposure hazards	Safer, impact-resistant
Shelf Life	Similar, with enhanced barrier plastics	Equal or better with advanced films
Environment	Recycling challenges	Biodegradable options emerging
Supply Chain	Heavier, more fragile	Lighter, more robust

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8. Potential Risks and Mitigation Strategies

Risk	Impact	Mitigation
Regulatory Delays	Halts in adoption	Early engagement with regulators
Manufacturing Challenges	Product inconsistency	Pilot testing and quality controls
Market Resistance	Slower adoption	Stakeholder education and marketing
Environmental Policy Changes	Future restrictions	Investment in biodegradable plastics
Patent Litigation	Market access issues	Patent landscape analysis

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9. Strategic Recommendations

• Accelerate development of advanced barrier plastics to improve shelf life.
• Engage early with regulatory authorities to streamline approval processes.
• Invest in marketing emphasizing safety, environmental, and cost benefits.
• Diversify packaging options to include biodegradable plastics.
• Monitor patent sunset timelines to optimize market entry timing.

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10. Key Takeaways

• Transitioning BreVibloc in plastic containers aligns with industry trends favoring safety, cost-efficiency, and environmental sustainability.
• Market size is expected to grow from $275 million in 2022 to over $370 million by 2025, with significant acceleration post-2023.
• Competitive dynamics favor early adopters with innovative packaging solutions and strong regulatory engagement.
• Cost reductions via plastic adoption enhance profitability margins, especially as market share expands.
• Regulatory and environmental policies will significantly shape product design, positioning, and marketing strategies moving forward.

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FAQs

Q1: What are the main benefits of switching BreVibloc packaging from glass to plastic?
A1: Enhanced safety by reducing breakage, lower shipping and handling costs due to lighter weight, improved supply chain resilience, and potential environmental benefits with biodegradable plastics.

Q2: How does regulatory oversight impact this packaging transition?
A2: Regulatory agencies like the FDA and EMA require validation studies confirming safety, stability, and inertness of plastics, which can influence timelines and investment in new packaging development.

Q3: Is the adoption of plastic containers financially advantageous?
A3: Yes, primarily through reduced raw material costs, decreased logistics expenses, and lower disposal costs. As production scales up, margins are expected to improve further.

Q4: What environmental considerations are involved in plastic container adoption?
A4: The shift toward biodegradable plastics aims to reduce environmental impact. Regulatory frameworks increasingly favor such solutions, but implementation depends on material development and cost.

Q5: When can stakeholders expect full transition and market saturation?
A5: Based on current growth forecasts, full market adoption and saturation for Brevibloc in plastic containers are projected around 2025–2026, contingent on regulatory approval and industry acceptance.

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References

[1] U.S. Food and Drug Administration (FDA). “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics,” 2021.

[2] European Medicines Agency (EMA). "Guidelines on stability testing of medicinal products," 2022.

[3] Industry Reports on Pharmaceutical Packaging Market, IQVIA, 2022.

[4] Green Pharma Initiative, 2022.

[5] ISO 15378:2017. "Primary packaging materials for medicinal products — Qualification and characterization."

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Disclaimer: This analysis is based on publicly available data up to 2023 and industry insights. It aims to inform decision-making and does not constitute specific investment or regulatory advice.