Orange Book product · Brand (NDA)
TRELEGY ELLIPTA
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
At a glance
Sep 18, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 18, 2017
8 yr 11 mo ago
Today
Patent 7488827 expires
Listed drug substance patent expiration.
Dec 18, 2027
in 1 yr 6 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 11090294 expires
Listed method-of-use patent (U-3202) expiration.
Nov 29, 2030
in 4 yr 6 mo
Patent 12396986 expires
Listed drug product patent expiration.
Nov 29, 2030
in 4 yr 6 mo
Patent 9750726 expires
Listed drug product patent expiration.
Nov 29, 2030
in 4 yr 6 mo
Patent 8746242*PED expires
Listed listed patent expiration.
Apr 11, 2031
in 4 yr 11 mo
Pharmaceutical detail
Active ingredient
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Strength
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 209482
Product number
001
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.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7488827 | Dec 18, 2027 | in 1 yr 6 mo | SubstanceProduct |
| 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 |
| 11090294 | Nov 29, 2030 | in 4 yr 6 mo | U-3202 |
| 12396986 | Nov 29, 2030 | in 4 yr 6 mo | Product |
| 9750726 | Nov 29, 2030 | in 4 yr 6 mo | Product |
| 8746242*PED | Apr 11, 2031 | in 4 yr 11 mo |
