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	4,593,119*PED
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	6,528,540*PED
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	6,310,094*PED

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
European Patent Office	0065542	COMPOUNDS SUITABLE FOR TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
Denmark	1368019
Japan	S61501775

Market Dynamics and Financial Trajectory for BREVIBLOC in Plastic Container

Last updated: August 5, 2025

Introduction

Brevibloc (eszopiclone) represents a renowned pharmaceutical intervention traditionally supplied in glass vials. Recently, a strategic pivot has emerged within the pharmaceutical industry to assemble Brevibloc in plastic containers, driven by manufacturing innovation, supply chain optimization, and evolving market determinants. This analysis explores the key market dynamics, regulatory landscape, competitive factors, and financial prospects associated with Brevibloc's transition to plastic packaging.

Market Overview of Brevibloc

Brevibloc, classified as a beta-blocker, primarily serves for cardiovascular indications, including hypertension and arrhythmias. Its market importance lies in its well-established efficacy, safety profile, and broad prescriber base. Traditionally, sterile glass vials have been the packaging standard, ensuring product stability and preservability.

However, the rising emphasis on patient safety, dose accuracy, convenient administration, and supply chain resilience is catalyzing demand for alternative packaging formats like plastic containers. Plastic packaging offers benefits such as reduced weight, breakage resistance, and cost-effective manufacturing, aligning with contemporary market needs.

Market Dynamics Influencing Brevibloc in Plastic Containers

Regulatory Environment

The regulatory landscape significantly influences the adoption of plastic containers. Agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) enforce stringent standards concerning plastic materials used in pharmaceuticals, demanding rigorous testing for leachables, extractables, and stability.

Recent policy adaptations support plastics approved for drug delivery, provided extensive validation studies demonstrate equivalence to glass containers. This regulatory clarity eases market entry and fosters innovation in packaging solutions for drugs like Brevibloc.

Manufacturing Innovations and Supply Chain

Advances in polymer sciences have enhanced plastics'' chemical resistance, barrier properties, and biocompatibility. These innovations mitigate previous concerns over plastic-compatibility issues, including potential interactions with active pharmaceutical ingredients (APIs).

Supply chain resilience is another driving factor. Plastic containers are lighter and less prone to breakage, lowering shipping costs and supply disruptions, especially critical amid global logistics challenges like those witnessed during the COVID-19 pandemic.

Market demand and Patient-centric Considerations

Market consumers, including healthcare facilities and patients, increasingly favor flexible, easy-to-use packaging. Plastic containers facilitate continuous infusion systems, pre-filled syringes, and portability, enhancing adherence and convenience.

Clinicians also prefer plastics for their durability during transport and storage, notably for emergency and outpatient settings, making formulations like Brevibloc more accessible.

Competitive Landscape

The plastic container market for injectables is highly competitive, with established players like West Pharmaceutical Services, Nordson, and Baxter offering validated solutions. Transitioning Brevibloc into this domain necessitates alignment with these suppliers, leveraging their expertise to meet regulatory, safety, and quality benchmarks.

Additionally, brands adopting plastics face competition from existing glass-based formulations. Differentiation hinges on cost, stability, and user experience enhancements.

Market Challenges

Despite advantages, challenges persist:

• Material Compatibility and Stability: Ensuring no adverse interactions between plastics and Brevibloc.
• Regulatory Hurdles: Extended approval timelines due to the need for stability and compatibility data.
• Environmental Concerns: Rising scrutiny on single-use plastics mandates sustainable packaging solutions.
• Cost Implications: Transitioning production lines may involve substantial capital expenditure.

Financial Trajectory

Cost Implications and Pricing

Developing Brevibloc in plastic containers entails upfront capital investments in validation studies, manufacturing modifications, and regulatory filings. However, economies of scale and reduced shipping costs can offset these expenses over time.

Pricing strategies are influenced by the perceived value addition—secured safety, convenience, and supply chain robustness—allowing potential premium pricing in hospital outpatient or specialized care markets.

Market Adoption and Revenue Forecasts

Market adoption depends on regulatory approvals, prescriber acceptance, and supply chain efficiencies. Early-stage deployment might focus on niche markets such as emergency care or outpatient infusion centers, with broader adoption contingent on demonstrated benefits.

Forecasts indicate an incremental revenue increase aligned with market acceptance. Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by the overall expansion in injectable pharmaceuticals and packaging innovation.

Strategic Opportunities

Brands leveraging plastics for Brevibloc can capitalize on:

• Global expansion into emerging markets where lightweight, durable packaging reduces distribution costs.
• Product differentiation through pre-filled syringe formats.
• Partnership opportunities with logistics and packaging firms invested in sustainable plastics.

Risks and Mitigation

Financial risks include regulatory delays, market resistance, and unforeseen stability challenges. Mitigation strategies encompass early-stage validation, collaborative development with reputable plastics suppliers, and proactive regulatory engagement.

Conclusion

Transitioning Brevibloc into plastic containers aligns with evolving market trends emphasizing safety, efficiency, and supply resilience. While regulatory and technical hurdles exist, the long-term financial outlook appears favorable, especially with strategic partnerships, investment in validation, and sustainability initiatives. Early market entry, coupled with targeted marketing toward healthcare providers and patients, can secure a competitive edge and foster sustained revenue growth.

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Key Takeaways

• Regulatory Readiness: Ensure comprehensive validation of plastic materials, including stability and safety profiles, to expedite approval processes.
• Supply Chain Optimization: Utilize lightweight, durable plastics to reduce manufacturing and logistical costs, enhancing market competitiveness.
• Market Penetration Strategy: Focus initially on niche markets requiring flexible and portable formulations, then expand broadly.
• Innovation and Sustainability: Invest in environmentally friendly plastics to meet evolving regulatory and societal expectations.
• Strategic Collaborations: Partner with experienced packaging suppliers and regulatory consultants to streamline development and compliance.

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FAQs

1. What are the main advantages of packaging Brevibloc in plastic containers?
Plastic containers offer reduced weight, breakage resistance, improved safety, and manufacturing cost savings, facilitating better supply chain management and patient convenience.

2. How do regulatory agencies view plastic packaging for injectable drugs like Brevibloc?
Regulators require rigorous testing for compatibility, stability, and safety. Approved plastics must meet standards for leachables and extractables, with validation data demonstrating equivalence or superiority to glass.

3. What technical challenges exist in transitioning Brevibloc to plastic containers?
Ensuring chemical compatibility, maintaining API stability, preventing leaching, and achieving regulatory approval are key technical hurdles.

4. What is the potential impact on Brevibloc's market share due to packaging changes?
If successfully implemented, plastic packaging can enhance market share by improving safety, convenience, and supply chain efficiency, appealing to healthcare providers and patients.

5. How does sustainability influence the adoption of plastic containers in pharmaceuticals?
Environmental concerns are prompting the industry to develop biodegradable or recyclable plastics, balancing safety with environmental responsibility, which can influence regulatory and market acceptance.

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Sources:
[1] Regulatory guidance documents from FDA and EMA on plastic medical devices.
[2] Market research reports on injectable packaging trends.
[3] Industry publications on supply chain innovations and sustainability initiatives.