Fluticasone furoate
As of the edition of 20 October 2026, Fluticasone furoate is a small molecule: marketed, first approved in 2007 (CA); acts on NR3C1; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Breo Ellipta
- First approved
- 14 August 2007 (CA)
- Approvals on record
- 31 in 6 regions
- Holder of the most recent approval
- GSK; 6 holders in all
- Withdrawn from market
- 14 June 2022 (in some regions)
- Registered trials
- 103, 6 stopped early
- Disease areas
- Lungs and airways; Immune system; Ear, nose and throat; Infections; Heart and blood vessels; Mental health
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by GSK.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 8 | 2 | 2 |
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 14 | 12 | 1 | 0 |
| Phase 3 | 42 | 40 | 0 | 2 |
| Phase 4 | 22 | 16 | 3 | 2 |
| All trials | 103 |