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. Fifteen 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:	5
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	16
Patent Applications:	811
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

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
Austria	20878
Australia	546424
Australia	7893881
Canada	1258868	COMPOSES .beta.-ADRENOLYTIQUES A ACTION COURTE, CONTENANT UN ESTER ET PROCEDE DE PRODUCTION (SHORT-ACTING, ESTER-CONTAINING (BETA)-ADRENERGIC BLOCKING COMPOUNDS AND PROCESS FOR MAKING SAME)
Germany	3174993
Denmark	164660
Denmark	335082

Last updated: July 30, 2026

Brevibloc Double Strength in Plastic Container Market Dynamics and Financial Trajectory (2024–2029): Pricing, Demand, Competition, and IP/Launch Risks

Executive summary: Brevibloc Double Strength in a plastic container is a niche critical-care beta-blocker product with demand driven by perioperative and ICU use, supply stability, and payer contracting. Financial trajectory is likely to track (1) hospital formulary retention and substitution to generics or reformulated branded equivalents, (2) inventory cycle management and tender pricing, (3) any supply disruptions, and (4) patent/exclusivity and FDA regulatory status affecting market entry of competing concentrated metoprolol injection products. Downside risk is concentrated in contract renegotiations and competitive entry; upside is tied to sustained ICU share and conversion to hospital-managed stock programs.

What is Brevibloc Double Strength in a plastic container and how is it used commercially?

Answer: Brevibloc is a brand of esmolol hydrochloride injection used for rapid control of tachyarrhythmias and perioperative heart rate control. “Double Strength” refers to a higher concentration presentation used to reduce infusion volume and improve dosing precision in intensive care and operative settings. The “plastic container” indicates a specific dosage-form packaging configuration that can affect storage, handling, and hospital procurement preferences.

Commercial use drivers

• ICU and OR workflow fit: Concentrated esmolol reduces line time and infusion bag volume.
• Clinical protocol alignment: Hospital order sets and anesthesiology pathways drive stickiness once a product is contracted.
• Tender and group purchasing organization (GPO) dynamics: ICU beta-blocker selections are often price- and supply-sensitive.

Where value is earned

• Net price vs WAC: Hospital purchasing targets net pricing, rebates, and contract tiering.
• Supply reliability: Procurement decisions weight lead times and continuity during peak demand.

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How do hospital procurement and payer contracting shape Brevibloc Double Strength demand?

Answer: Demand is structurally tied to institutional formulary status, contract tiers, and infusion protocol adoption rather than outpatient prescribing. Pricing pressure is primarily driven by tender competition and generic substitution economics.

What procurement levers determine volume

• Formulary inclusion for ICU beta-blockers (esmolol is used when rapid titration is needed)
• Substitution rules in hospitals (therapeutic interchange, concentration equivalency, and packaging acceptance)
• Inventory and pharmacy management (concentrated products can reduce storage footprint in some settings)
• Pharmacy automation and compounding workflows (plastic containers can align with handling standards)

What payer dynamics matter

• Commercial and Medicare Part D is less central than hospital inpatient purchasing.
• Inpatient reimbursement is mostly DRG/contracting-driven, making the key commercial variable the hospital’s net cost and budget impact.

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What market dynamics influence pricing for Brevibloc Double Strength?

Answer: Pricing is pulled down by (1) generic and authorized generic competition in concentrated esmolol injection, (2) annual contract rebids, and (3) bid-based procurement cycles. It is supported by supply stability and clinical familiarity.

Key pricing mechanics

• Contract rebasing: Net price can reset at 6–12 month intervals based on GPO schedules and rebid outcomes.
• Concentration-based competition: “Double Strength” gets compared against equivalent concentration presentations, not just “esmolol injection” broadly.
• Packaging-specific competition: If rivals use different container formats, hospitals may require a clinical and operational equivalency review before switching.

Supply and inventory cycle effects

• Shortages raise realized prices (net price temporarily increases through emergency procurement premiums).
• Normalized supply compresses gross-to-net as wholesalers and distributors push competitive SKUs.

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When does Brevibloc Double Strength lose exclusivity and what is the launch timing risk?

Answer: This section requires specific patent/exclusivity and Orange Book listing data for “Brevibloc Double Strength in plastic container” to calculate precise exclusivity loss and generic entry windows. Without the product’s FDA NDC, Orange Book reference drug name, and listed exclusivity/patent numbers, a complete and accurate exclusivity timeline cannot be produced.

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What patents protect Brevibloc Double Strength in plastic container and how strong is the estate?

Answer: This section requires the FDA Orange Book patent listing record tied to Brevibloc Double Strength’s exact dosage form, strength, and container configuration (and the corresponding Orange Book “listed drug” identifier). Without the exact listing, the patent estate coverage, expiration dates, and litigation posture cannot be stated accurately.

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How many generics or competing concentrated esmolol injections could enter and what generic entry risks exist?

Answer: This section requires the competitive set from the Orange Book (ANDA/BLA submissions that cite the exact reference listed drug and strength), plus any ongoing Paragraph IV litigation outcomes under Hatch-Waxman. Without those records, the count of challengers, potential 180-day exclusivity holders, and entry-risk mapping cannot be completed.

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What is the Orange Book status of Brevibloc Double Strength (plastic container)?

Answer: Orange Book status is product-specific and requires the exact listed drug name and NDC. Without the listing, the following cannot be provided accurately:

• exclusivity type (new chemical entity, new therapeutic indication, pediatric, etc.)
• expiration dates
• patent numbers and remaining terms
• whether any ANDA approvals or tentative approvals are on file

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What patent litigation or settlement agreements affect Brevibloc Double Strength revenue?

Answer: Litigation affects expected market erosion, including:

• timing of generic launches
• scope of “design-around” injunctions
• early settlement-triggered entry dates

A complete and accurate assessment requires docket-level identification of cases involving the exact reference listed drug and strength. Without case identifiers and the relevant complaint/settlement dates, litigation impact cannot be mapped reliably.

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How does Brevibloc Double Strength compare with other esmolol injection brands and generics?

Answer: A rigorous comparison requires specific competitors by concentration, container type, and FDA approval status, plus net price benchmarks. Without product-level competitor identifiers, the competitive comparison cannot be completed in a way that supports actionable business decisions.

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What is the FDA regulatory status for Brevibloc Double Strength (plastic container) and how does it affect supply?

Answer: FDA regulatory status (approval pathway, labeling, manufacturing site controls, and any manufacturing modifications impacting supply) is product-specific. Without the exact FDA label/NDC mapping, this cannot be stated accurately.

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What manufacturing and IP barriers block competitors from making a “double strength” plastic-container equivalent?

Answer: IP and manufacturing barriers depend on whether competitors can:

• match the exact strength/concentration and container configuration
• satisfy formulation and stability requirements for the plastic container
• navigate any remaining formulation or packaging patents

This requires a product-specific patent and CMC record tied to the exact strength and packaging configuration.

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Revenue exposure: how much does Brevibloc Double Strength contribute and what are the risk factors to its financial trajectory?

Answer: Revenue exposure cannot be quantified without:

• company segment reporting tied to the product line
• wholesaler or NDC-level sales data
• time-series net price and unit volume

Without those datasets and product identifiers, any revenue numbers would be non-actionable.

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Key Takeaways

• Brevibloc Double Strength in a plastic container is a hospital-driven, critical-care beta-blocker with pricing and volume primarily shaped by formulary status, tender cycles, and supply stability.
• Financial trajectory is most sensitive to contract rebids (net price compression), generic substitution timing, and any supply interruptions.
• A precise exclusivity/Orange Book-based timeline, patent strength assessment, and generic entry scenario mapping require product-specific FDA listing and patent data tied to the exact dosage form, strength, and container configuration. Without that mapping, exclusivity loss, litigation impact, and launch risk cannot be stated accurately.

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FAQs

1. How do plastic-container and concentration differences affect substitution of esmolol injection in hospitals?
2. What drives net price volatility for concentrated esmolol products during tender rebids?
3. How does ICU protocol standardization influence long-term market share for esmolol injection brands?
4. What Orange Book listing fields determine the timing of generic erosion for concentrated IV products?
5. How do 180-day exclusivity holders and Paragraph IV settlements change entry strategy for esmolol injection?

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References (APA)

[No citations provided because product-specific FDA/Orange Book/patent and litigation records were not provided in the request.]