FDA Orange Book · active-ingredient family
Fluticasone furoate; vilanterol trifenatate
Fluticasone furoate; 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:BREO ELLIPTA · NDA 204275
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
4
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BREO ELLIPTARLD×3 | GLAXO GRP LTD | NDA 204275 | — | May 12, 2023 |
Marketing exclusivity (4)
- NSNew strength exclusivity (3 years)
May 13, 2026
1 mo ago
- PEDPediatric exclusivity (adds 6 months)
Nov 13, 2026
in 5 mo
- NPPNew patient population 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 |
Fluticasone furoate; vilanterol trifenatate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
