Orange Book product · Brand (NDA)
ANORO ELLIPTA
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
At a glance
Dec 18, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2013
12 yr 8 mo ago
Today
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 7488827 expires
Listed drug substance patent expiration.
Dec 18, 2027
in 1 yr 6 mo
Patent 11090294 expires
Listed method-of-use patent (U-3203) 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
Pharmaceutical detail
Active ingredient
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Strength
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 203975
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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8511304 | Jun 14, 2027 | in 1 yr | ProductU-1476 |
| 8511304*PED | Dec 14, 2027 | in 1 yr 6 mo | |
| 7488827 | Dec 18, 2027 | in 1 yr 6 mo | SubstanceProduct |
| 11090294 | Nov 29, 2030 | in 4 yr 6 mo | U-3203 |
| 12396986 | Nov 29, 2030 | in 4 yr 6 mo | Product |
| 9750726 | Nov 29, 2030 | in 4 yr 6 mo | Product |
