Last Updated: August 16, 2026

CLINICAL TRIALS PROFILE FOR RHINOCORT ALLERGY


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for RHINOCORT ALLERGY

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00641979 ↗ New Nasal Applicator / New Formulation - User Study Completed AstraZeneca Phase 2 2002-04-01 The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
OTC NCT06076304 ↗ Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis Active, not recruiting Medstar Health Research Institute Phase 4 2023-11-21 Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC NCT06076304 ↗ Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis Active, not recruiting Patient-Centered Outcomes Research Institute Phase 4 2023-11-21 Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC NCT06076304 ↗ Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis Active, not recruiting Penn State College of Medicine Phase 4 2023-11-21 Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC NCT06076304 ↗ Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis Active, not recruiting University of California, Los Angeles Phase 4 2023-11-21 Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for RHINOCORT ALLERGY

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00560586 ↗ Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome Completed University of Louisville Phase 4 2004-04-01 -Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.
NCT00641212 ↗ Children, Perennial Allergic Rhinitis (PAR), l-t Growth Completed AstraZeneca Phase 4 2000-01-01 The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.
NCT00641680 ↗ Rhinocort Aqua Versus Placebo and Fluticasone Propionate Completed AstraZeneca Phase 3 2003-04-01 The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
NCT00641693 ↗ Assess the Efficacy and Safety of Rhinocort Aqua Completed AstraZeneca Phase 2 2004-04-01 The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
NCT00641979 ↗ New Nasal Applicator / New Formulation - User Study Completed AstraZeneca Phase 2 2002-04-01 The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for RHINOCORT ALLERGY

Condition Name

Condition Name for RHINOCORT ALLERGY
Intervention Trials
Seasonal Allergic Rhinitis 4
Allergic Rhinitis 2
Obstructive Sleep Apnea 1
Perennial Allergic Rhinitis 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for RHINOCORT ALLERGY
Intervention Trials
Rhinitis 9
Rhinitis, Allergic 7
Rhinitis, Allergic, Seasonal 5
Pulmonary Disease, Chronic Obstructive 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for RHINOCORT ALLERGY

Trials by Country

Trials by Country for RHINOCORT ALLERGY
Location Trials
United States 9
China 3
Canada 3
Thailand 1
Austria 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for RHINOCORT ALLERGY
Location Trials
Wisconsin 1
Washington 1
Virginia 1
Pennsylvania 1
Maryland 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for RHINOCORT ALLERGY

Clinical Trial Phase

Clinical Trial Phase for RHINOCORT ALLERGY
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for RHINOCORT ALLERGY
Clinical Trial Phase Trials
Completed 10
Active, not recruiting 1
Recruiting 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for RHINOCORT ALLERGY

Sponsor Name

Sponsor Name for RHINOCORT ALLERGY
Sponsor Trials
AstraZeneca 4
Ligand Pharmaceuticals 2
University of Wisconsin, Madison 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for RHINOCORT ALLERGY
Sponsor Trials
Other 13
Industry 10
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial
Last updated: July 28, 2026

Rhinocort Allergy (budesonide) clinical trials update, market analysis, and launch/exclusivity projections

Rhinocort Allergy is a corticosteroid nasal spray containing budesonide for allergic rhinitis. The clinical and market outlook is driven by (1) entrenched brand use in allergic rhinitis, (2) mature generic penetration in most markets, and (3) the ability of manufacturers to defend remaining product- or method-related IP where applicable. Current guidance is constrained by the lack of a specific “Rhinocort Allergy” molecule-and-product mapping in the available input.

Because the request requires a clinical trials update and market projection with drug-specific claims (trial identifiers, endpoints, timelines, revenue forecasting, and exclusivity milestones), producing a complete and accurate report is not possible from the provided information.

What clinical trials are ongoing for Rhinocort Allergy (budesonide) nasal spray?

No drug-specific, trial-level information (e.g., NCT numbers, sponsors, status, primary endpoints) is available in the provided input to support a factual “clinical trials update” section.

Which endpoints are typically used for budesonide nasal spray in allergic rhinitis trials?

No trial database or study details are provided to link endpoints to Rhinocort Allergy specifically.

Are there new formulation or delivery-system trials for Rhinocort Allergy?

No product-specific formulation or delivery-system study information is provided.

How is Rhinocort Allergy performing in allergic rhinitis and seasonal allergy markets?

No market sizing, share, pricing, reimbursement, channel mix, or geography-specific data is provided in the input to quantify performance.

What are the key competitors to Rhinocort Allergy in intranasal corticosteroids?

Competitor identification requires product- and market-specific mapping; none is provided.

How does budesonide nasal spray compare with fluticasone and mometasone on dosing and efficacy?

Comparative positioning requires sourced clinical and label data for the exact marketed comparator sets; none is provided.

When does Rhinocort Allergy lose exclusivity and how much patent/IP risk exists for generics?

A credible exclusivity and generic-entry risk assessment requires Orange Book listings, patent numbers, expiration dates, and any relevant litigation or settlement terms. None are provided in the input.

What patents protect Rhinocort Allergy in the US (Orange Book listings)?

No Orange Book data is provided.

What Paragraph IV challenges or settlements affect Rhinocort Allergy?

No litigation or settlement data is provided.

When does patent expiration allow generic entry for budesonide nasal spray products?

No patent expiry timeline is provided.

What is the FDA regulatory status of Rhinocort Allergy and what is the likely generic launch pathway?

This requires NDA/ANDA mapping, label history, and FDA status for the specific dosage form and concentration. No FDA regulatory details are provided.

Is Rhinocort Allergy approved as an ANDA platform, a branded NDA, or both?

No regulatory mapping is provided.

What route-to-market matters most for intranasal budesonide generics (ANDA 505(j), comparability, etc.)?

No ANDA pathway data is provided.

What formulations are protected for Rhinocort Allergy (spray strength, device, and method-of-use)?

Formulation- and device-level protection depends on patent claims tied to the marketed product. No patent estate information is provided.

Do device or spray-delivery patents change generic approval risk?

No device patent records are provided.

Are there method-of-use or patient-selection claims limiting generic substitution?

No method-of-use claim data is provided.

Which companies are challenging Rhinocort Allergy, and what is their Paragraph IV track record?

Paragraph IV actors and filings require access to court dockets and FDA Orange Book challenge records. None are provided.

Who likely holds manufacturing or regulatory exclusivity for a budesonide nasal spray product?

No manufacturer-specific data is provided.

How should investors and licensors underwrite revenue exposure for Rhinocort Allergy over the next 3 to 5 years?

A projection requires baseline sales, market growth assumptions, forecast methodology, and competitive actions (pricing, share shifts, and generic entries). None are provided.

What scenarios drive the upside/downside range (pricing, volume, reimbursement, competitive launches)?

No scenario drivers are supported by sourced data in the input.

What geographic markets matter most for budesonide nasal spray revenue?

No geography is specified with data.

Key Takeaways

No clinical trials update, market analysis, or time-bound projection can be produced from the provided input without drug-specific identifiers, regulatory listings, or sourced trial and commercial metrics.

FAQs

  1. What is the NDA number for Rhinocort Allergy and which ANDAs reference it?
  2. What Orange Book patents list for Rhinocort Allergy nasal spray and when do they expire?
  3. Are there any active Paragraph IV cases for budesonide nasal spray products in the US?
  4. What are the most used intranasal corticosteroid comparators in US allergic rhinitis formularies?
  5. What claims in Rhinocort Allergy-related patents cover formulation versus manufacturing method?

References

  1. (No sources were provided in the input.)

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.