Orange Book product · Brand (NDA)
ARMONAIR DIGIHALER
FLUTICASONE PROPIONATE
At a glance
Feb 20, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 20, 2020
6 yr 5 mo ago
Today
Patent 10195375 expires
Listed drug product patent expiration.
Feb 14, 2031
in 4 yr 9 mo
Patent 10195375*PED expires
Listed listed patent expiration.
Aug 14, 2031
in 5 yr 3 mo
Patent 10918816 expires
Listed drug product patent expiration.
Dec 14, 2035
in 9 yr 8 mo
Patent 10918816*PED expires
Listed listed patent expiration.
Jun 14, 2036
in 10 yr 2 mo
Patent 11969544 expires
Listed drug product patent expiration.
Aug 20, 2039
in 13 yr 4 mo
Patent 11344685 expires
Listed drug product patent expiration.
Sep 26, 2039
in 13 yr 6 mo
Patent 11969544*PED expires
Listed listed patent expiration.
Feb 20, 2040
in 13 yr 10 mo
Patent 11344685*PED expires
Listed listed patent expiration.
Mar 26, 2040
in 14 yr
Patent 11173259 expires
Listed drug product patent expiration.
Jul 06, 2040
in 14 yr 3 mo
Patent 11173259*PED expires
Listed listed patent expiration.
Jan 06, 2041
in 14 yr 9 mo
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE
Strength
0.232MG/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 208798
Product number
006
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2017XHANCEBrand (NDA)
NDA 209022 · PARATEK PHARMS
- 2014FLONASE ALLERGY RELIEFBrand (NDA)
NDA 205434 · HALEON US HOLDINGS
- 2005CUTIVATEBrand (NDA)
NDA 021152 · FOUGERA PHARMS
- 2004FLOVENT HFABrand (NDA)
NDA 021433 · GLAXO GRP LTD
- 2000FLOVENT DISKUS 100Brand (NDA)
NDA 020833 · GLAXO GRP LTD
- 1997FLOVENTBrand (NDA)
NDA 020549 · GLAXOSMITHKLINE
- 1996FLOVENTBrand (NDA)
NDA 020548 · GLAXOSMITHKLINE
- 1994FLONASEBrand (NDA)
NDA 020121 · HALEON US HOLDINGS
- 1990CUTIVATEBrand (NDA)
NDA 019958 · FOUGERA PHARMS
- 1990CUTIVATEBrand (NDA)
NDA 019957 · FOUGERA PHARMS
- 2026FLUTICASONE PROPIONATEGeneric (ANDA)
ANDA 218742 · GLENMARK SPECLT
- 2026FLUTICASONE PROPIONATEGeneric (ANDA)
ANDA 219602 · GLENMARK SPECLT
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10195375 | Feb 14, 2031 | in 4 yr 9 mo | Product |
| 10195375*PED | Aug 14, 2031 | in 5 yr 3 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 |
