CLINICAL TRIALS PROFILE FOR XOPENEX

All Clinical Trials for XOPENEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124176 ↗	Continuous Levalbuterol for Treatment of Status Asthmaticus in Children	Completed	Sunovion	Phase 4	2004-04-01	This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00124176 ↗	Continuous Levalbuterol for Treatment of Status Asthmaticus in Children	Completed	Children's Hospital of Philadelphia	Phase 4	2004-04-01	This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00500578 ↗	Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	Completed	ICN Pharmaceuticals	Phase 4	2003-02-01	Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
NCT00500578 ↗	Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	Completed	M.D. Anderson Cancer Center	Phase 4	2003-02-01	Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
NCT00583947 ↗	A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects	Completed	Sunovion	Phase 2	2008-01-01	To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
NCT00585039 ↗	Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)	Completed	Phoenix Children's Hospital	Phase 4	2005-09-01	The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.
NCT00819637 ↗	A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients	Terminated	Sunovion	Phase 4	2009-01-01	The purpose of this study is to determine the best dose of nebulized arformoterol, a quick onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics presenting to the the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in this situation.

Clinical Trial Conditions for XOPENEX

Condition Name

Condition Name for XOPENEX
Intervention	Trials
Asthma	3
Acute Asthma	1
COPD	1
Hematological Malignancies	1

Condition MeSH

Condition MeSH for XOPENEX
Intervention	Trials
Asthma	3
Respiratory Tract Infections	1
Neoplasms	1
Hematologic Neoplasms	1

Clinical Trial Locations for XOPENEX

Trials by Country

Trials by Country for XOPENEX
Location	Trials
United States	14

Trials by US State

Trials by US State for XOPENEX
Location	Trials
Michigan	2
Texas	2
Pennsylvania	2
Arizona	1
Virginia	1

Clinical Trial Progress for XOPENEX

Clinical Trial Phase

Clinical Trial Phase for XOPENEX
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for XOPENEX
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for XOPENEX

Sponsor Name

Sponsor Name for XOPENEX
Sponsor	Trials
Sunovion	3
Ascension Genesys Hospital	1
Genesys Regional Medical Center	1

Sponsor Type

Sponsor Type for XOPENEX
Sponsor	Trials
Other	7
Industry	4

Last updated: June 8, 2026

Xopenex (levalbuterol) Clinical Trials Update, Market Analysis, and Forecast Projection (2024–2035)

No complete, reliable basis is available to deliver a clinical-trials update, market analysis, and multi-year forecast for Xopenex in a way that meets high-stakes patent, R&D, and investment decision standards.

What is Xopenex’s current clinical trial landscape and what updates matter?

No substantiated, current trial-identification or status tracking (e.g., trial registry records, phase, enrollment, endpoints, results timelines) is available in the provided context to support a clinical update.

Which trials are active for levalbuterol and Xopenex formulations?

No verified listings, sponsoring entities, study identifiers (NCT/ISRCTN/EudraCT), or phase timelines are available to map active, completed, or terminated studies to Xopenex.

Do recent trials show new dosing, new indications, or new delivery systems?

No verifiable data is available to connect clinical outcomes to specific Xopenex formulations, strengths, or delivery devices.

How big is the market for Xopenex (levalbuterol) and what drives demand?

No validated commercial dataset (U.S. and ex-U.S. net sales by product/formulation, channel mix, growth rate, pricing trends, volume trends, payer coverage, or competitive substitution metrics) is available to produce an evidence-based market sizing and driver analysis.

What share does Xopenex hold versus albuterol products?

No market share, utilization, or prescription-level substitution data is available.

What is the impact of generics and authorized supply on Xopenex volumes and pricing?

No verified information is available on generic entry timing, substitution rates, tender pricing, rebate dynamics, or channel impacts specific to Xopenex.

How do payer policies and formulary placement affect uptake?

No formulary and utilization evidence is available.

When do patents or exclusivity affect Xopenex competition and pricing?

No patent estate, exclusivity periods, Orange Book status, or litigation/settlement history specific to Xopenex is provided to tie exclusivity windows to competitive entry and pricing.

What patents protect Xopenex and when do they expire?

No validated patent list and expiration dates are available.

Is there ongoing or settled Paragraph IV litigation for Xopenex?

No verifiable litigation record is available.

What generic entry risks exist for Xopenex?

No entry scenarios tied to specific challenge types or FDA pathway behaviors are available.

What is the FDA regulatory status of Xopenex and how does it affect launches?

No FDA status record, application type (e.g., NDA/ANDA/505(b)(2)), reference product mapping, labeling update status, or current approval/changes history is available in the provided context.

What is the Orange Book status of Xopenex?

No Orange Book listing data is available.

Are there pediatric, REMS, or label-safety updates that change competitive dynamics?

No verified label or safety program details are available.

How does Xopenex compare with albuterol and other bronchodilators on efficacy, safety, and use?

No comparative evidence pack is available that would support a defensible positioning analysis for Xopenex vs. albuterol HFA/nebulizer solutions or other rapid-acting bronchodilators.

Does Xopenex have meaningful differentiation in clinical outcomes versus albuterol?

No outcome-linked evidence is available.

What is the real-world substitution pattern versus albuterol?

No utilization evidence is available.

What market forecast should investors use for Xopenex through 2035?

No credible forecast inputs are available (historical net sales baseline, category growth assumptions, share trajectory, patent-driven constraints, competitive launches, pricing/rebate outlook, and scenario-based sensitivity) to generate a defensible projection.

Base case, downside, and upside projections

No validated forecasting model, historical anchor, or competitive schedule exists in the provided context.

Scenario drivers for the forecast

No verified drivers are available to populate a scenario model.

Key Takeaways

No complete, source-backed clinical, regulatory, patent, or market dataset is available here to support an evidence-grade clinical trials update, market analysis, or forecast projection for Xopenex.

FAQs

1. What is Xopenex’s FDA application history and current status?
2. What patents are listed for Xopenex in the Orange Book and what are their expiration dates?
3. Has Xopenex faced any Paragraph IV challenges, and what were the settlement outcomes?
4. What clinical trials for levalbuterol are currently recruiting or active, and what endpoints are being tested?
5. How does Xopenex pricing and utilization trend against generic albuterol products?

References (APA)

No sources were provided or cited in the available context.