BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Brevibloc Double Strength In Plastic Container, and when can generic versions of Brevibloc Double Strength In Plastic Container launch?

Brevibloc Double Strength In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in BREVIBLOC DOUBLE STRENGTH 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 Double Strength In Plastic Container

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

Summary for BREVIBLOC DOUBLE STRENGTH 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 DOUBLE STRENGTH IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for BREVIBLOC DOUBLE STRENGTH 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 DOUBLE STRENGTH IN PLASTIC CONTAINER clinical trials

Pharmacology for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

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

US Patents and Regulatory Information for BREVIBLOC DOUBLE STRENGTH 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 DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	AP	RX	Yes	Yes

Expired US Patents for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	4,593,119*PED
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	6,528,540*PED
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	6,310,094*PED

International Patents for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

See the table below for patents covering BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1242395	COMPOSES PHARMACEUTIQUES ET METHODE DE TRAITEMENT OU DE PROPHYLAXIE DES TROUBLES CARDIAQUES (PHARMACEUTICAL COMPOSITION AND METHOD FOR TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS)
Slovakia	288113
Greece	76921

Market Dynamics and Financial Trajectory for BREVIBLOC Double Strength in Plastic Container

Last updated: July 27, 2025

Introduction

Brevinok (esmolol hydrochloride), marketed under BREVIBLOC, is a rapid-onset, short-acting beta-1 selective adrenergic blocker primarily indicated for perioperative and emergency management of supraventricular tachycardia and hypertension. The recent commercialization of BREVIBLOC Double Strength in plastic containers marks a strategic shift aimed at optimizing supply chain efficiency, reducing waste, and enhancing patient safety. This article examines the market landscape, key drivers, competitive positioning, and financial prospects associated with this formulation change.

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Market Overview and Context

The global cardiac care pharmacotherapy segment is driven significantly by demand for effective, fast-acting beta blockers in acute care settings. BREVIBLOC's narrow therapeutic window necessitates careful handling and administration, traditionally through glass vials. Transitioning to plastic containers—specifically double-strength formulations—aligns with modern procurement and storage strategies.

The cardiovascular drugs market was valued at approximately USD 39.2 billion in 2022 and is projected to grow at a CAGR of around 4.2% through 2027 [1]. Within this, injectable agents like esmolol constitute a key segment, owing to their critical role in emergency and perioperative settings. The shift toward advanced container systems responds face the challenge of increasing demand while reducing logistical costs.

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Market Dynamics

1. Supply Chain Optimization

Plastic containers offer notable advantages over glass, including reduced fragility, decreased breakage, and enhanced portability. The move to double-strength formulation enables more precise dosing, minimizes waste, and extends shelf life. These factors resonate with hospital procurement priorities shifting toward cost efficiency and safety.

2. Regulatory Landscape

Regulatory bodies such as the FDA and EMA are emphasizing stricter standards for drug packaging, including sterility, stability, and traceability. The adoption of plastic containers must comply with these standards, which can pose initial hurdles but ultimately supports market credibility.

3. Clinical and Safety Considerations

Plastic containers reduce the risk of glass shards contaminating the drug, a key safety concern. Their compatibility with hospital storage and ease of handling addresses practical clinical needs, especially in high-acuity environments.

4. Economic and Reimbursement Factors

Double-strength formulations reduce administration volume and frequency, potentially decreasing hospital resource utilization. These economic benefits are increasingly valued by healthcare providers operating under budget constraints.

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Financial Trajectory and Revenue Potential

1. Market Adoption and Sales Forecast

The adoption rate of BREVIBLOC Double Strength hinges on institutional preference shifts, regulatory approvals, and clinician acceptance. Given the established efficacy of esmolol, the incremental revenue from new packaging leverages existing demand.

Projected sales growth can be estimated based on hospital procurement figures, with an initial market penetration estimate of around 15-20% within the first two years, assuming steady acceptance.

2. Pricing Strategy

The double strength formulation permits a marginal price premium—estimated at 10-15% over standard formulations—justified by enhanced safety, reduced waste, and convenience. Although hospital procurement often pressures prices downward, the operational savings justify the premium.

3. Cost Savings and Margin Impact

Manufacturing costs for plastic containers, especially double-strength formulations, are lower in the long term due to reduced packaging volume and waste. This can translate into improved gross margins, assuming stable demand.

4. Competitive Positioning

Competitors like Baxter and Pfizer also offer beta blockers in various formats. Differentiation through packaging innovation and clinical advantages positions BREVIBLOC favorably, especially if regulatory and hospital adoption barriers are effectively navigated.

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Market Drivers and Challenges

Key Drivers:

• Growing demand for rapid-onset, short-duration beta blockers in emergency care.
• Emphasis on cost-effective, safe, and user-friendly packaging.
• Regulatory encouragement for improved drug stability and safety.

Challenges:

• Slow regulatory approval in certain regions for new container types.
• Resistance from institutions accustomed to traditional glass vials.
• Competition from established generic formulations and alternative agents.

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Strategic Considerations for Stakeholders

• Manufacturers: Focus on robust regulatory submissions, clinical validation, and clinician education.
• Distributors: Emphasize supply chain efficiencies and cost savings.
• Healthcare Providers: Prioritize safety, ease of use, and operational savings.
• Investors: Monitor adoption rates, regulatory milestones, and competitive moves for valuation impacts.

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Conclusion

The introduction of BREVIBLOC Double Strength in plastic containers signifies a pivotal evolution in the beta blocker market. By aligning product features with emerging clinical and economic trends, this formulation is positioned for steady growth. While initial adoption may be gradual, the long-term outlook favors improvements in safety, supply chain efficiency, and clinical effectiveness, which together can drive meaningful revenue trajectories.

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Key Takeaways

• The shift to plastic containers for BREVIBLOC Double Strength enhances safety, reduces waste, and aligns with hospital operational needs.
• Market demand for rapid-onset beta blockers remains robust, driven by the escalation of acute cardiac care requirements.
• Cost savings and operational efficiencies support a premium pricing strategy, with forecasted growth contingent upon regulatory approval and clinician adoption.
• Competitive differentiation depends on regulatory success, clinical validation, and hospital education.
• Long-term revenue growth prospects are favorable, provided the product maintains compliance and gains market acceptance within sophisticated healthcare procurement channels.

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FAQs

1. What are the primary advantages of BREVIBLOC Double Strength in plastic containers?
It offers improved safety by eliminating glass shard risk, reduces waste through higher potency per unit, enhances portability, and simplifies dosing procedures.

2. How does the double-strength formulation impact hospital usage?
It decreases the volume required per dose, lowering storage requirements, and potentially reducing overall drug costs and administration time.

3. What regulatory hurdles might influence market penetration?
Approval processes for new packaging materials, stability testing, and compliance with sterility standards can delay adoption in certain regions.

4. How does this formulation compare cost-wise to traditional versions?
Initially, it may command a slight price premium, but operational savings from reduced waste and efficient dosing offset the higher unit cost over time.

5. What is the future outlook for BREVIBLOC in the global cardiac care market?
Given ongoing demand for emergency and perioperative beta blockers, coupled with innovations in packaging, its market trajectory appears positive, especially with continued regulatory and clinical validation.

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Sources:
[1] Global Market Insights, "Cardiovascular Drugs Market Size," 2022.