Last Updated: June 25, 2026

BREVIBLOC IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. 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 In Plastic Container

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

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for BREVIBLOC IN PLASTIC CONTAINER?
  • What are the global sales for BREVIBLOC IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for BREVIBLOC IN PLASTIC CONTAINER?
Recent Clinical Trials for BREVIBLOC IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zagazig UniversityPhase 2
Cristália Produtos Químicos Farmacêuticos Ltda.Phase 4
University Hospital Bispebjerg and FrederiksbergPhase 4

See all BREVIBLOC IN PLASTIC CONTAINER clinical trials

Pharmacology for BREVIBLOC IN PLASTIC CONTAINER
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: June 22, 2026

BreviBloc in plastic container market dynamics and financial trajectory

BreviBloc in a plastic container is a U.S.-market adrenaline (epinephrine) injection product positioned in acute care for anaphylaxis and other emergency indications. Market performance is driven by hospital formularies, ER and ICU utilization, inventory practices, adverse-event and safety-driven procurement rules, and payor reimbursement dynamics. Financial trajectory depends on (1) generic and authorized-duplicates competition, (2) tendering and group purchasing organization (GPO) pricing pressure, (3) low-volume but high-acuity demand patterns that favor reliable supply and ready-to-use presentation, and (4) the ability of the branded product to defend exclusivity and manage product life-cycle transitions tied to FDA approval history and Orange Book stay requirements.

Bottom line for business planning: BreviBloc’s financial trajectory in the plastic-container presentation is typically more volume-stable than elective therapies but more price-sensitive. The main swings come from substitution into lower-cost generics and from procurement contracting cycles rather than from incremental clinical adoption.


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

Featured snippet: Brevibloc (epinephrine) injection is an emergency injectable drug; commercial demand is dominated by hospital acute-care use and procurement contracting rather than outpatient prescribing.

Drug identity relevant to market and pricing

  • Active ingredient: epinephrine
  • Dosage form/presentation: injection in plastic container (ready-to-use format used in acute care settings)
  • Therapeutic category: emergency cardiovascular and anaphylaxis management

Commercial use pattern

  • Site-of-care: Emergency departments, ICUs, anesthesia services, inpatient wards with rapid response workflows.
  • Adoption driver: shelf reliability and clinician familiarity; standardized kits and medication trays.
  • Procurement driver: contract pricing, bid cycles, and substitution rules in formularies.

How fast does the market shift when generics or authorized duplicates enter?

Featured snippet: In hospital emergency injectables, price declines and share loss often accelerate immediately after generic availability or after contract renegotiations.

Typical dynamics in acute epinephrine injection

  • Bid-driven replacement: hospitals often reselect products at procurement renewals, not continuously.
  • Formulary substitution: if a therapeutically equivalent generic or authorized duplicate is available, switching is usually administratively faster.
  • Supply reliability as a gating factor: even with price advantages, procurement favors consistent supply and compliant labeling.

What to track for share erosion

  • GPO and wholesaler contract updates
  • secondary market indications: substitutions at hospital pharmacy level (not always visible in public prescribing data)
  • case pack and distribution channel pricing

What patents protect Brevibloc in plastic container and what does that mean for pricing power?

Featured snippet: Patent protection for a specific epinephrine presentation typically determines whether competitors can offer an equivalent product at scale without entry constraints.

Where protection usually concentrates

For injectable drug products in plastic containers, competitive constraints can arise from:

  • Composition claims (epinephrine concentration and formulation specifics)
  • Method-of-manufacture claims (sterility assurance, container closure integrity process)
  • Formulation or stability claims (compatibility with plastic, antioxidants/pH targets, shelf-life)
  • Delivery-system/container integrity claims (container closure system properties)

How patent estate strength maps to financial trajectory

  • Strong protection + limited substitutes: supports higher net price and steadier revenue.
  • Weak or narrow protection: shifts value to distribution contracts and accelerates net price erosion.

(Patent and Orange Book mapping is usually required to quantify specific expiration dates and barrier strength; public details must be verified directly from FDA listings for this exact product and container presentation.)


When does Brevibloc lose exclusivity for the plastic container presentation?

Featured snippet: Exclusivity loss timing for a specific presentation is determined by the FDA approval history and any Orange Book-listed exclusivity or patents tied to that NDA label.

Exclusivity and entry triggers to map

  • Orange Book patent expiration and “ready for approval” dates
  • Market-entry timelines for generics/authorized duplicates
  • Potential FDA exclusivity types: application exclusivity and any listed time-limited periods tied to approval

Commercial effect

  • Ahead of expiration: revenue typically holds while competitors wait; bids may tighten but contracts often remain stable.
  • At/after expiration: pricing pressure increases and net revenue declines usually outpace unit volume reductions.

What is the Orange Book status of Brevibloc in plastic container?

Featured snippet: The Orange Book status determines whether there are listed patents that block generic approval or whether entry is already possible without patent litigation leverage.

What an Orange Book check is used for

  • Identify listed patents and their expiration dates
  • Determine whether any patents are flagged for method-of-use, formulation, or manufacturing
  • Assess entry readiness and likely Paragraph IV strategy by challengers

Commercial decision use

  • Licensing strategy: whether any remaining exclusivity creates leverage for settlements or portfolio buys
  • Litigation strategy: whether defendants are likely to negotiate earlier based on remaining patent life

Which companies compete with Brevibloc in plastic container?

Featured snippet: Competition in epinephrine injections typically comes from generic manufacturers and, depending on market structure, authorized duplicates supplying hospital channels.

Competitive landscape drivers

  • Wholesale channel availability
  • Contract pricing
  • Manufacturing capacity and supply consistency
  • Regulatory status and listing behavior in FDA databases

How competitor entry affects BreviBloc financials

  • Net price compression: branded gross-to-net margin falls first.
  • Unit share shift: follows once procurement contracts change.
  • Revenue volatility: increases during tender cycles and after supply disruptions among competitors.

What generic entry risks exist for Brevibloc in plastic container?

Featured snippet: Entry risk is highest when patent barriers for the specific presentation are narrow or near expiration and when equivalent generics can supply hospitals at contract scale.

Risk factors

  • Patent expirations for container-specific or formulation-specific claims
  • Generic product approvals that can rely on comparative safety/efficacy while differing in manufacturing process
  • Litigation posture by any existing challengers
  • Operational ability of generics to meet hospital supply and labeling requirements

Practical risk signal

  • Tender announcements that name lower-cost therapeutically equivalent products
  • Wholesaler substitution behavior and updated hospital inventory lists

What patent litigation affects Brevibloc and how does it change revenue?

Featured snippet: Patent litigation impacts revenue through settlement timing, generic launch delays, and negotiated “carve-outs” that can preserve branded share or shift it temporarily.

Common litigation-to-revenue pathways

  • Early settlement before launch: branded revenue stability improves until contract renegotiation.
  • No settlement or late settlement: unit and net price decline accelerates after launch.
  • Narrow injunction scope: may preserve only some dosage strengths or container formats.

What financial models typically assume

  • Litigation reduces immediate generic launch probability
  • Settlement delays shift cannibalization later but often do not prevent eventual price compression

How does Brevibloc compare with other epinephrine injection products by unit economics?

Featured snippet: In emergency injectables, unit economics are dominated by net price (contracted and rebated) rather than retail demand.

Key comparison axes

  • Presentation: plastic container versus glass compatibility and handling
  • Dose strengths and fill volumes: hospital kit integration
  • Shelf-life and stability: impacts inventory costs
  • Contract pricing: drives gross-to-net and margin

Where branded products still hold value

  • Supply reliability track record
  • Reduced medication error risk from standardization
  • Formulary position and bundled purchasing

How do hospital procurement and tender cycles drive Brevibloc financial trajectory?

Featured snippet: Revenue inflects at the points when hospital contracts reset, not when clinical guidelines change.

Procurement mechanics that matter

  • GPO contract renewals: multi-month cadence and volume commitments
  • Tender selection: competitive bids that favor low acquisition cost
  • Formulary tiering: affects replenishment frequency
  • Distribution channel margins: wholesaler rebates and distribution economics

What to measure to forecast financials

  • Net price per unit by channel (GPO vs. non-GPO)
  • Volume stability around contract renewals
  • Inventory days and reorder frequency (acute-care turnover is typically high but demand is event-driven)

What regulatory factors shape Brevibloc plastic-container supply and cost?

Featured snippet: Regulatory requirements for sterile injectables and container closure integrity influence manufacturing cost and supply continuity, which in turn affect pricing and revenue.

Relevant regulatory cost drivers

  • Sterile manufacturing controls and batch release timelines
  • Container closure integrity testing and stability documentation
  • Labeling and substitution compliance in hospital formularies

Financial effect

  • Supply constraints can briefly support pricing, but long-term results depend on the competitive price floor once generics scale.

What is the likely revenue exposure profile over the life cycle?

Featured snippet: Brevibloc’s revenue is exposed to step-changes from entry and contract renegotiations rather than gradual linear erosion.

Life-cycle phases

  1. Pre-competition / protected period: revenue supported by formulary lock-in and tender awards.
  2. Early competition window: net price declines begin, volume may hold temporarily.
  3. Post-entry normalization: share shifts and margin compresses.
  4. Mature generic environment: revenue becomes largely a function of contract share, not brand preference.

Model-ready assumptions for forecasting

  • Expect net price compression to lead revenue decline.
  • Expect volume decline to follow if the product is de-listed or tier-down occurs.
  • Anticipate wider revenue dispersion across quarters due to tender timing.

Key Takeaways

  • BreviBloc in plastic container is an acute-care epinephrine injection whose commercial demand is hospital-driven and contract-driven.
  • The financial trajectory is most sensitive to generic/authorized-duplicate entry and GPO tender resets, which typically drive net price declines and share erosion.
  • Patent and Orange Book status for the exact plastic-container presentation determines whether competitors face launch barriers and how much pricing power the brand can sustain.
  • Revenue inflects in step-changes aligned to exclusivity and litigation outcomes plus procurement cycling, not clinical adoption cycles.
  • Competitive pressure in emergency injectables is usually rapid once entry is feasible and supply scales through hospital channels.

FAQs

  1. How do GPO contract changes affect branded epinephrine injection net revenue most?
  2. Do plastic-container presentations face different generic substitution dynamics than glass vials?
  3. What Orange Book patent types (formulation, method, manufacturing) most influence generic launch timing for injectables?
  4. How should a financial model treat litigation settlements for hospital emergency injectable products?
  5. What operational metrics (batch release, stability, supply continuity) most correlate with pricing hold versus wholesale substitution?

References

  1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. U.S. Food and Drug Administration. Drugs@FDA database.

(No additional sources are included because no specific FDA listing identifiers, patent numbers, or litigation docket details were provided.)

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.