FDA Orange Book · active-ingredient family
Umeclidinium bromide; vilanterol trifenatate
Umeclidinium bromide; vilanterol trifenatate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ANORO ELLIPTA · NDA 203975
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANORO ELLIPTARLD | GLAXOSMITHKLINE | NDA 203975 | — | Dec 18, 2013 |
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 |
| 9750726 | Nov 29, 2030 | in 4 yr 6 mo | Product |
| 12396986 | Nov 29, 2030 | in 4 yr 6 mo | Product |
Umeclidinium bromide; vilanterol trifenatate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
