Orange Book product · Brand (NDA)
BREO ELLIPTA
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
At a glance
May 12, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 12, 2023
3 yr 2 mo ago
Exclusivity ends · NS
New strength exclusivity (3 years)
May 13, 2026
1 mo ago
Today
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 13, 2026
in 5 mo
Patent 8511304 expires
Listed drug product patent expiration.
Jun 14, 2027
in 1 yr
Patent 8511304*PED expires
Listed listed patent expiration.
Dec 14, 2027
in 1 yr 6 mo
Patent 11116721 expires
Listed drug product patent expiration.
Feb 26, 2029
in 2 yr 9 mo
Patent 11116721*PED expires
Listed listed patent expiration.
Aug 26, 2029
in 3 yr 3 mo
Patent 8534281 expires
Listed drug product patent expiration.
Mar 08, 2030
in 3 yr 9 mo
Patent 8534281*PED expires
Listed listed patent expiration.
Sep 08, 2030
in 4 yr 3 mo
Patent 8746242 expires
Listed drug product patent expiration.
Oct 11, 2030
in 4 yr 5 mo
Patent 8746242*PED expires
Listed listed patent expiration.
Apr 11, 2031
in 4 yr 11 mo
Pharmaceutical detail
Active ingredient
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Strength
0.05MG/INH;EQ 0.025MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 204275
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NSNew strength exclusivity (3 years)
May 13, 2026
1 mo ago
- PEDPediatric exclusivity (adds 6 months)
Nov 13, 2026
in 5 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8511304 | Jun 14, 2027 | in 1 yr | ProductU-3623 |
| 8511304*PED | Dec 14, 2027 | in 1 yr 6 mo | |
| 11116721 | Feb 26, 2029 | in 2 yr 9 mo | ProductU-3623 |
| 11116721*PED | Aug 26, 2029 | in 3 yr 3 mo | |
| 8534281 | Mar 08, 2030 | in 3 yr 9 mo | Product |
| 8534281*PED | Sep 08, 2030 | in 4 yr 3 mo | |
| 8746242 | Oct 11, 2030 | in 4 yr 5 mo | Product |
| 8746242*PED | Apr 11, 2031 | in 4 yr 11 mo |

