TheraRadar
Data updated: May 26, 2026

QVAR REDIHALER (beclomethasone dipropionate)

Respiratory Approved 2017-08-03

QVAR REDIHALER is indicated for the treatment of Asthma.

Source: FDA Label • NORTON WATERFORD
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-08-03
Patent Cliff
2041

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Routes
INHALATION
Dosage Forms
AEROSOL, METERED

Companies

Active Ingredient: BECLOMETHASONE DIPROPIONATE

QVAR REDIHALER Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2017 to 2025
Sep 2025 SUPPL
Label · Labeling
Jan 2021 SUPPL
Label · Labeling
Aug 2017 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What QVAR REDIHALER Treats

1 indications

QVAR REDIHALER is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
Source: FDA Label

QVAR REDIHALER Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT04320342 TRITON CLI-05993AA3-06 2020-002389-16 Ph 3 completed A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD
NCT05292586 FORCE2 results posted CLI-05993AB8-02 Ph 3 completed A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
NCT04873063 PSC DS BDP-Once 1 Ph 1 completed Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers
NCT00988247 results posted BDP-AR-303 Ph 3 completed Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
NCT01024608 results posted BDP-AR-301 Ph 3 completed Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
NCT02139644 results posted FSS-AS-301 2014-001149-25 Ph 3 completed Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT02031640 results posted BDB-AS-301 2013-003397-27 Ph 3 completed A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
NCT00565266 TALC results posted 547 U10HL074206, U10HL074208 Ph 3 completed Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)
NCT01016223 32508 Ph 1 completed A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis
NCT01133626 results posted BDP-AR-304 Ph 3 completed Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
NCT01113489 0002565 Ph 3 completed Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

QVAR REDIHALER FDA Label Details

Indications & Usage

FDA Label (PDF)

QVAR REDIHALER is indicated for the treatment of Asthma.

View full patent landscape →
8 OB patents · 5 families · 108 international docs across 21 countries

QVAR REDIHALER Patents & Exclusivity

Latest Patent: Aug 2041

Patents (8 active)

US11583643 Expires Aug 19, 2041
US11957832 Expires May 5, 2041
US11559637 Expires Jul 21, 2039
US10792447 Expires Jan 25, 2039
US12296089 Expires Jan 26, 2038
US11793953 Expires Jan 26, 2038
US11395888 Expires Jan 26, 2038
US8931476 Expires Jul 17, 2031
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for QVAR REDIHALER

Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2041
  • 32 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.