FDA Orange Book · active-ingredient family
Fluticasone propionate; salmeterol xinafoate
Fluticasone propionate; salmeterol xinafoate is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AIRDUO DIGIHALER · NDA 208799
3
Brand (NDA)
4
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AIRDUO DIGIHALERRLD×6 | TEVA PHARM | NDA 208799 | — | Jul 12, 2019 | |
| ADVAIR HFARLD×3 | GLAXO GRP LTD | NDA 021254 | — | Jun 08, 2006 | |
| ADVAIR DISKUS 100/50RLD×3 | GLAXO GRP LTD | NDA 021077 | AB | Aug 24, 2000 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE×2 | RESPIRENT PHARMS | ANDA 214464 | — | Jan 12, 2026 | |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE×3 | TEVA PHARMS USA | ANDA 213948 | AB | Dec 13, 2021 | |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE×3 | HIKMA | ANDA 203433 | AB | Dec 17, 2020 | |
| WIXELA INHUB×3 | MYLAN | ANDA 208891 | AB | Jan 30, 2019 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10195375 | Feb 14, 2031 | in 4 yr 9 mo | Product |
| 10195375*PED | Aug 14, 2031 | in 5 yr 3 mo | |
| 9415008 | Oct 06, 2034 | in 8 yr 5 mo | ProductU-645 |
| 9066957 | Oct 06, 2034 | in 8 yr 5 mo | ProductU-645 |
| 9415008*PED | Apr 06, 2035 | in 8 yr 11 mo | |
| 9066957*PED | Apr 06, 2035 | in 8 yr 11 mo | |
| 10918816 | Dec 14, 2035 | in 9 yr 8 mo | Product |
| 10918816*PED | Jun 14, 2036 | in 10 yr 2 mo | |
| 11969544 | Aug 20, 2039 | in 13 yr 4 mo | Product |
| 11344685 | Sep 26, 2039 | in 13 yr 6 mo | Product |
| 11969544*PED | Feb 20, 2040 | in 13 yr 10 mo | |
| 11344685*PED | Mar 26, 2040 | in 14 yr | |
| 11173259 | Jul 06, 2040 | in 14 yr 3 mo | Product |
| 11173259*PED | Jan 06, 2041 | in 14 yr 9 mo |
Fluticasone propionate; salmeterol xinafoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
