CLINICAL TRIALS PROFILE FOR ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

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All Clinical Trials for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00302692 ↗	Use of Beta Blockers in Elderly Trauma Patients	Unknown status	American Heart Association	Phase 2	2005-12-01	Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.
NCT00302692 ↗	Use of Beta Blockers in Elderly Trauma Patients	Unknown status	University of Texas Southwestern Medical Center	Phase 2	2005-12-01	Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	PDL BioPharma, Inc.	Phase 4	2004-01-01	Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.

Clinical Trial Conditions for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

Condition Name

Condition Name for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Intervention	Trials
Septic Shock	10
Hypertension	6
Postoperative Pain	6
Anesthesia	6

Condition MeSH

Condition MeSH for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Intervention	Trials
Shock, Septic	12
Shock	12
Pain, Postoperative	9
Tachycardia	6

Clinical Trial Locations for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Location	Trials
United States	28
China	26
Egypt	17
Brazil	10
France	7

Trials by US State

Trials by US State for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Location	Trials
California	6
Illinois	5
Utah	2
North Carolina	2
New York	2

Clinical Trial Progress for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	47
Unknown status	25
Recruiting	25

Clinical Trial Sponsors for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Sponsor	Trials
Ain Shams University	5
The University of Hong Kong	4
Baxter Healthcare Corporation	4

Sponsor Type

Sponsor Type for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Sponsor	Trials
Other	153
Industry	15
OTHER_GOV	1

Last updated: July 28, 2026

Esmolol Hydrochloride Double Strength in Plastic Container: Clinical Trials Update, Market Analysis, and Revenue Projection

What is esmolol hydrochloride double strength in plastic container and where does it sit in the portfolio?

Esmolol hydrochloride is an ultra–short-acting, IV beta-1 selective beta blocker used for acute rate control and perioperative or procedural hemodynamic management. The “double strength” presentation in a plastic container is a formulation-specific product configuration (concentration and container/ready-to-use packaging), which can affect interchangeability, labeling scope, and competitive pull in hospital formularies.

Product concept (presentation level):

• Active ingredient: esmolol hydrochloride
• Dosage form: IV infusion solution
• Key differentiators: double-strength concentration and plastic container presentation that supports administration logistics and stock management in acute care settings.

Business implication: Market demand is driven by hospital use patterns for short-duration IV titration. “Double strength” tends to be positioned for reduced infusion volume and ease of preparation, which can matter for ICU workflows and catheter/line management. The container system can also influence procurement and substitution behavior, especially where group purchasing organizations standardize specific SKUs.

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What clinical trials exist for IV esmolol hydrochloride in acute care, perioperative settings, and tachyarrhythmias?

A comprehensive trials inventory requires direct cross-referencing of:

• ClinicalTrials.gov interventional records
• publications and trial registries
• labeling-relevant subpopulations (e.g., perioperative tachycardia, atrial fibrillation/flutter, SVT, hemodynamically unstable states)

No complete, product-specific clinical trial update is producible from the information available in this prompt. The drug can be studied broadly as esmolol, but the “double strength in plastic container” SKU-level data and trial linkage must be evidenced through registration identifiers, protocol publications, or FDA labeling supplements tied to that exact presentation.

Result: A factual “clinical trials update” cannot be completed to a defensible standard for this specific product presentation without verifiable trial mapping.

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What is the current market size for IV esmolol hydrochloride and how does “double strength in plastic container” change share?

Market drivers for IV esmolol:

• Acute care volume: ICU and perioperative surgical case load
• Indications: short-term rate control and hemodynamic control where rapid titration and quick offset are clinically preferred
• Formularies: restrictions and preferred agents lists for beta blockers, antiarrhythmics, and rate-control protocols
• Supply and procurement: GPO contracting and tender cycles for IV infusion products

Where presentation matters:

• Concentration affects dosing unit economics (units per patient episode)
• Plastic container affects usability, waste profile, and nursing preference
• Substitution risk: if pharmacy systems substitute by strength and route without SKU lock, the “double strength” advantage can compress

Commercial lens that can be quantified once SKU-level supply and pricing are identified:

• Unit demand (infusion vials/bags per 1,000 bed-days or per perioperative case)
• Net revenue (ASP net of rebates, chargebacks)
• Channel mix (GPO hospital vs. IDN distribution vs. specialty/acute procurement)

No pricing, unit share, or distribution data is available in the prompt to produce a quantified market sizing or share estimate specifically for this “double strength in plastic container” product.

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When does esmolol hydrochloride lose exclusivity and what IP barriers block generic entry?

For a marketed IV small-molecule like esmolol hydrochloride, exclusivity and patent strategy typically depends on:

• formulation patents (concentration-specific, container-specific, stability-related, or manufacturing-method claims)
• method-of-use patents (if any are still active)
• reference listed drug (RLD) and any listed patents in the Orange Book for the relevant strength/container configuration

No Orange Book listing details, patent numbers, expiration dates, or paragraph IV history are provided in the prompt. A correct exclusivity and generic-entry timeline must be computed from:

• Orange Book patent list for the exact presentation
• regulatory exclusivity periods (if applicable)
• any relevant litigation/settlements tied to that presentation

Result: A timeline and legal barrier map cannot be generated without cited Orange Book and litigation records for this exact SKU.

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What generic entry risks exist for “double strength in plastic container” and do biosimilars apply?

Biosimilars: Not applicable. Esmolol hydrochloride is a small molecule. The competitive threat is generics and authorized generics, not biosimilars.

Generic entry risk factors (SKU-specific):

• whether the listed patents cover concentration, container, or formulation/process
• whether the product is a preferred strength under hospital protocols
• substitution rules and tender standardization that can slow switching even if IP is cleared

No patent or regulatory dossier is included in the prompt, so a defensible generic-entry risk assessment cannot be produced.

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How does this esmolol presentation compare with other esmolol strengths, alternative IV beta blockers, and competing rate-control agents?

A comparison that is actionable for procurement and investment analysis needs:

• therapeutic comparators used in the same care pathways (e.g., labetalol, metoprolol IV products, diltiazem IV, amiodarone protocols depending on indication)
• relative onset/offset profile and titration characteristics
• procurement pricing and formulary tier placement

The prompt does not provide comparator data, labeling, or pricing, so a quantitative competitive comparison is not supportable.

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What is the FDA regulatory status of esmolol hydrochloride double strength in plastic container and what filings are active?

A factual regulatory status requires:

• FDA Orange Book record for the exact strength and dosage form
• current labeling and distribution status
• ANDA/505(j) pipeline entries and approval dates for same-RLD therapeutics
• any ongoing post-marketing supplements that tie to the plastic container or “double strength” configuration

No FDA record identifiers are included, so regulatory status cannot be stated with accuracy.

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How should revenue projection be built for this product, and what inputs are required to finalize the model?

A credible revenue projection for a hospital-administered IV small molecule should be structured as:

Revenue = (US treated episodes × dosing volume per episode × net price per unit) + non-US contribution

Where:

• US treated episodes are driven by ICU and perioperative case volumes and formulary adoption
• dosing volume per episode depends on protocol and the product’s concentration (double strength can reduce container count)
• net price reflects GPO rebates, wholesaler discounts, and tender pricing
• non-US revenue depends on local approvals and competitive set

The prompt provides no:

• current sales, unit volume, ASP/AMP, or forecast base year
• country coverage
• pricing terms or tender dynamics

So the final numeric projection cannot be produced.

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Key Takeaways

• Esmolol hydrochloride is a clinically established IV beta-1 selective beta blocker with hospital-driven demand patterns.
• “Double strength in plastic container” is a presentation-level configuration that can influence dosing unit economics and procurement preferences.
• A defensible clinical trials update, exclusivity/generic-entry timeline, FDA/Orange Book status, and quantified market and revenue projection cannot be completed from the information provided in the prompt.

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FAQs

1. How do concentration and container format affect substitution for IV esmolol in hospital pharmacies?
2. What nonclinical or stability data typically supports shelf-life claims for IV esmolol formulations in plastic containers?
3. What are the main competitive threats to IV esmolol in the US hospital market: pricing pressure, formulary changes, or IP challenges?
4. How are acute rate-control protocols selecting between IV beta blockers and IV calcium channel blockers in perioperative settings?
5. What indicators in FDA databases (Orange Book, ANDA approvals) best predict generic entry timing for established IV small molecules?

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References (APA)

No cited sources were provided or identifiable from the prompt.