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Pulmicort Respules (BUDESONIDE)
Pulmicort Respules (Budesonide) is a corticosteroid medication developed by AstraZeneca K.K. and currently owned by Astrazeneca. It targets the glucocorticoid receptor to treat various respiratory and gastrointestinal conditions, including asthma, allergic rhinitis, and Crohn's disease. Pulmicort Respules is a small molecule modality with a 2.8-hour half-life and 37% bioavailability. The medication is off-patent, with 21 generic manufacturers available. Key safety considerations include potential side effects such as oral thrush and adrenal suppression.
At a glance
| Generic name | BUDESONIDE |
|---|---|
| Sponsor | AstraZeneca K.K. |
| Drug class | Corticosteroid [EPC] |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1994 |
| Annual revenue | 2800 |
Approved indications
- Allergic Rhinitis Prevention
- Allergic rhinitis
- Asthma
- Asthma management
- Chronic Non-Allergic Rhinitis
- Crohn's disease
- Crohn's disease in remission
- Eosinophilic esophagitis
- Primary immunoglobulin A nephropathy
- Severe chronic obstructive pulmonary disease
Common side effects
- Headache
- Respiratory Infection
- Nausea
- Back Pain
- Dizziness
- Dyspepsia
- Abdominal Pain
- Flatulence
- Vomiting
- Fatigue
- Pain
- Acne
Drug interactions
- aripiprazole
- boceprevir
- quetiapine
- risperidone
- telaprevir
- warfarin
Key clinical trials
- Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery (PHASE4)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis (PHASE2)
- Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant (PHASE2)
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9192581 | 2031-09-07 | Formulation |
| 9707182 | 2036-09-09 | Formulation |
| 10172802 | 2036-09-09 | Method of Use |
| 11896719 | 2043-01-23 | Method of Use |
| 12171882 | 2043-01-23 | Method of Use |
| 12311057 | 2043-01-23 | Formulation |
| 9119863 | 2026-11-09 | Method of Use |
| 8975243 | 2026-11-09 | Method of Use |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pulmicort Respules CI brief — competitive landscape report
- Pulmicort Respules updates RSS · CI watch RSS
- AstraZeneca K.K. portfolio CI