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FDA Orange Book · active-ingredient family

Fluticasone propionate

Fluticasone propionate is approved as 11 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARMONAIR DIGIHALER · NDA 208798

11

Brand (NDA)

24

Generics (ANDA)

13

Listed patents

2

Exclusivity periods

Brand (NDA) products · aerosol, metered, cream, lotion, ointment, powder, spray, metered

ProductApplicantApplicationTEApproved
ARMONAIR DIGIHALERRLD×8TEVA PHARMNDA 208798—Apr 08, 2022
XHANCERLDPARATEK PHARMSNDA 209022—Sep 18, 2017
FLONASE ALLERGY RELIEFRLDHALEON US HOLDINGSNDA 205434—Jul 23, 2014
CUTIVATERLDFOUGERA PHARMSNDA 021152—Mar 31, 2005
FLOVENT HFARLD×3GLAXO GRP LTDNDA 021433ABMay 14, 2004
FLOVENT DISKUS 100RLD×3GLAXO GRP LTDNDA 020833—Sep 29, 2000
FLONASERLDHALEON US HOLDINGSNDA 020121—Oct 19, 1994
CUTIVATERLDFOUGERA PHARMSNDA 019958—Dec 18, 1990
CUTIVATERLDFOUGERA PHARMSNDA 019957—Dec 14, 1990
FLOVENT×3GLAXOSMITHKLINENDA 020549—Nov 07, 1997
FLOVENT×3GLAXOSMITHKLINENDA 020548—Mar 27, 1996

Generic (ANDA) products (24)

ProductApplicantApplicationTEApproved
FLUTICASONE PROPIONATEGLENMARK SPECLTANDA 218742—Mar 16, 2026
FLUTICASONE PROPIONATEGLENMARK SPECLTANDA 219602ABMar 03, 2026
FLUTICASONE PROPIONATERUBICON RESEARCHANDA 219060—Aug 15, 2025
FLUTICASONE PROPIONATERUBICON RESEARCHANDA 218321ABJun 05, 2025
FLUTICASONE PROPIONATEAUROBINDO PHARMA LTDANDA 217088—May 10, 2024
FLUTICASONE PROPIONATEBRIGHTANDA 215343—Sep 01, 2023
FLUTICASONE PROPIONATEHIKMAANDA 208024—Apr 17, 2019
FLUTICASONE PROPIONATEHIKMAANDA 207957—May 26, 2016
FLUTICASONE PROPIONATEAPOTEXANDA 208150—Feb 29, 2016
FLUTICASONE PROPIONATEPADAGIS ISRAELANDA 091553—Jul 30, 2013
FLUTICASONE PROPIONATECHARTWELL RXANDA 078492ABJan 09, 2012
FLUTICASONE PROPIONATEGLENMARK PHARMS LTDANDA 090759—May 02, 2011
FLUTICASONE PROPIONATEHIKMAANDA 077570—Jan 16, 2008
FLUTICASONE PROPIONATEAPOTEXANDA 077538ABSep 12, 2007
FLUTICASONE PROPIONATECOSETTE PHARMS NCANDA 077055ABJun 30, 2006
FLUTICASONE PROPIONATECOSETTE PHARMS NCANDA 077168ABMar 03, 2006
FLUTICASONE PROPIONATEHIKMAANDA 076504ABFeb 22, 2006
FLUTICASONE PROPIONATETARO PHARM INDSANDA 077145—Jun 14, 2005
FLUTICASONE PROPIONATENESHER PHARMSANDA 076865—Sep 10, 2004
FLUTICASONE PROPIONATEENCUBEANDA 076633ABMay 14, 2004
FLUTICASONE PROPIONATEFOUGERA PHARMSANDA 076451ABMay 14, 2004
FLUTICASONE PROPIONATEPADAGIS ISRAELANDA 076793ABMay 14, 2004
FLUTICASONE PROPIONATECHARTWELL RXANDA 076300—May 14, 2004
FLUTICASONE PROPIONATEPADAGIS ISRAELANDA 076668ABMay 14, 2004

Marketing exclusivity (2)

  • CGTFDA marketing exclusivity

    Sep 20, 2026

    in 3 mo

  • I-940New indication exclusivity (3 years)

    Mar 15, 2027

    in 9 mo

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10195375Feb 14, 2031in 4 yr 9 mo
Product
12083270Apr 04, 2031in 4 yr 10 mo
U-2133
10195375*PEDAug 14, 2031in 5 yr 3 mo
10918816Dec 14, 2035in 9 yr 8 mo
Product
11554229Feb 23, 2036in 9 yr 10 mo
U-2133
12616806Feb 23, 2036in 9 yr 10 mo
U-4524
10918816*PEDJun 14, 2036in 10 yr 2 mo
11969544Aug 20, 2039in 13 yr 4 mo
Product
11344685Sep 26, 2039in 13 yr 6 mo
Product
11969544*PEDFeb 20, 2040in 13 yr 10 mo
11344685*PEDMar 26, 2040in 14 yr
11173259Jul 06, 2040in 14 yr 3 mo
Product
11173259*PEDJan 06, 2041in 14 yr 9 mo

Fluticasone propionate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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