Last reviewed · How we verify
Arnuity Ellipta (FLUTICASONE FUROATE)
Fluticasone Furoate (Arnuity Ellipta), marketed by Haleon US Holdings, is a glucocorticoid receptor agonist primarily indicated for nasal congestion relief. Its key strength lies in its mechanism of action, which effectively reduces inflammation and swelling in the airways, positioning it as a strong competitor in the market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | FLUTICASONE FUROATE |
|---|---|
| Sponsor | Haleon Us Holdings |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2007 |
| Annual revenue | 3100 |
Approved indications
- Nasal Congestion Relief
- Runny Nose Relief
- Sneezing Relief
- Itchy Nose Relief
- Itchy, Watery Eyes Relief
Common side effects
- Upper respiratory tract infection
- Pneumonia
- Bronchitis
- Oral candidiasis
- Arthralgia
- Influenza
- Sinusitis
- Pharyngitis
- Rhinitis
- Constipation
- Urinary tract infection
- Dysphonia
Key clinical trials
- A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (PHASE3)
- Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma (PHASE4)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps (PHASE3)
- A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (PHASE1,PHASE2)
- A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma (PHASE3)
- Efficacy of Low-Dose Topical Steroids in Maintaining Remission of Eosinophilic Esophagitis in Children
- Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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:
- Arnuity Ellipta CI brief — competitive landscape report
- Arnuity Ellipta updates RSS · CI watch RSS
- Haleon Us Holdings portfolio CI