Is there a generic for Fluticasone propionate?

Yes. The FDA Orange Book lists 25 approved generic (ANDA) applications for Fluticasone propionate, referencing the brand ARMONAIR DIGIHALER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluticasone propionate?

ARMONAIR DIGIHALER (NDA 208798, TEVA PHARM) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Fluticasone propionate?

The Orange Book lists 13 patents against Fluticasone propionate products, with the earliest listed expiry in 2031. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Fluticasone propionate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Fluticasone propionate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Fluticasone propionate are approved?

Fluticasone propionate is approved in the following dosage forms: aerosol, metered, cream, lotion, ointment, powder, spray, metered.

FDA Orange Book · active-ingredient family

Fluticasone propionate

Fluticasone propionate: 11 brands, 25 generics; first approved Dec 14, 1990; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 25 ANDA applications approved.

Earliest patent expiry Feb 14, 2031Latest exclusivity ends Mar 15, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 14, 2031

in 4 yr 6 mo

Brand (NDA) products

Originator applications

ARMONAIR DIGIHALERRLD

TEVA PHARMNDA 20879820228 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.055MG/INH	POWDER	INHALATION	Discontinued	—
0.113MG/INH	POWDER	INHALATION	Discontinued	—
0.232MG/INH	POWDER	INHALATION	Discontinued	—
0.055MG/INH	POWDER	INHALATION	Discontinued	—
0.113MG/INH	POWDER	INHALATION	Discontinued	—
0.232MG/INH	POWDER	INHALATION	Discontinued	—
0.03MG/INH	POWDER	INHALATION	Discontinued	—
0.03MG/INH	POWDER	INHALATION	Discontinued	—

XHANCERLDRS
PARATEK PHARMSNDA 2090222017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.093MG/SPRAY SPRAY, METERED NASAL Rx —
FLONASE ALLERGY RELIEFRLD
HALEON US HOLDINGSNDA 2054342014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
CUTIVATERLD
FOUGERANDA 0211522005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.093MG/SPRAY	SPRAY, METERED	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Discontinued	—

FLOVENT HFARLDRS

GLAXO GRP LTDNDA 02143320043 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.22MG/INH	AEROSOL, METERED	INHALATION	Rx	—
0.11MG/INH	AEROSOL, METERED	INHALATION	Rx	—
0.044MG/INH	AEROSOL, METERED	INHALATION	Rx	AB

FLOVENT DISKUS 100RLDRS
GLAXO GRP LTDNDA 02083320003 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/INH POWDER INHALATION Rx —
0.1MG/INH POWDER INHALATION Rx —
0.25MG/INH POWDER INHALATION Rx —
FLONASERLD
HALEON US HOLDINGSNDA 0201211994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Discontinued —
CUTIVATERLD
FOUGERANDA 0199581990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CUTIVATERLD
FOUGERANDA 0199571990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/INH	POWDER	INHALATION	Rx	—
0.1MG/INH	POWDER	INHALATION	Rx	—
0.25MG/INH	POWDER	INHALATION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Discontinued	—

FLOVENT

GLAXOSMITHKLINENDA 02054919973 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.044MG/INH	POWDER	INHALATION	Discontinued	—
0.088MG/INH	POWDER	INHALATION	Discontinued	—
0.22MG/INH	POWDER	INHALATION	Discontinued	—

FLOVENT

GLAXOSMITHKLINENDA 02054819963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.044MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—
0.11MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—
0.22MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Generic (ANDA) products (25)

Abbreviated applications

FLUTICASONE PROPIONATE
GLENMARK SPECLTANDA 2192322026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
FLUTICASONE PROPIONATE
GLENMARK SPECLTANDA 2187422026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
FLUTICASONE PROPIONATE
GLENMARK SPECLTANDA 2196022026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.044MG/INH AEROSOL, METERED INHALATION Rx AB
FLUTICASONE PROPIONATE
RUBICON RESEARCHANDA 2190602025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
FLUTICASONE PROPIONATE
RUBICON RESEARCHANDA 2183212025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
FLUTICASONE PROPIONATE
AUROBINDO PHARMA LTDANDA 2170882024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
FLUTICASONE PROPIONATE
BRIGHTANDA 2153432023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Discontinued —
FLUTICASONE PROPIONATE
HIKMAANDA 2080242019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Discontinued —
FLUTICASONE PROPIONATERS
HIKMAANDA 2079572016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
FLUTICASONE PROPIONATE
APOTEXANDA 2081502016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL OTC —
FLUTICASONE PROPIONATERS
PADAGIS ISRAELANDA 0915532013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx —
FLUTICASONE PROPIONATE
CHARTWELL RXANDA 0784922012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
FLUTICASONE PROPIONATE
GLENMARK PHARMS LTDANDA 0907592011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
FLUTICASONE PROPIONATE
HIKMAANDA 0775702008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Discontinued —
FLUTICASONE PROPIONATE
APOTEXANDA 0775382007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
FLUTICASONE PROPIONATE
COSETTE PHARMS NCANDA 0770552006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
FLUTICASONE PROPIONATE
COSETTE PHARMS NCANDA 0771682006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Rx AB
FLUTICASONE PROPIONATERS
HIKMAANDA 0765042006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
FLUTICASONE PROPIONATE
TARO PHARM INDSANDA 0771452005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Discontinued —
FLUTICASONE PROPIONATE
NESHER PHARMSANDA 0768652004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
FLUTICASONE PROPIONATE
ENCUBEANDA 0766332004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
FLUTICASONE PROPIONATE
FOUGERA PHARMSANDA 0764512004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
FLUTICASONE PROPIONATERS
PADAGIS ISRAELANDA 0767932004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
FLUTICASONE PROPIONATE
CHARTWELL RXANDA 0763002004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Discontinued —
FLUTICASONE PROPIONATERS
PADAGIS ISRAELANDA 0766682004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% OINTMENT TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.044MG/INH	AEROSOL, METERED	INHALATION	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	OINTMENT	TOPICAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

CGTFDA marketing exclusivity
Sep 20, 2026
2 d ago
I-940New indication exclusivity (3 years)
Mar 15, 2027
in 6 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10195375	Feb 14, 2031	in 4 yr 6 mo	Product
12083270	Apr 04, 2031	in 4 yr 7 mo	U-2133
10195375*PED	Aug 14, 2031	in 5 yr
10918816	Dec 14, 2035	in 9 yr 4 mo	Product
11554229	Feb 23, 2036	in 9 yr 7 mo	U-2133
12616806	Feb 23, 2036	in 9 yr 7 mo	U-4524
10918816*PED	Jun 14, 2036	in 9 yr 10 mo
11969544	Aug 20, 2039	in 13 yr 1 mo	Product
11344685	Sep 26, 2039	in 13 yr 2 mo	Product
11969544*PED	Feb 20, 2040	in 13 yr 7 mo
11344685*PED	Mar 26, 2040	in 13 yr 8 mo
11173259	Jul 06, 2040	in 14 yr	Product
11173259*PED	Jan 06, 2041	in 14 yr 6 mo

Approval history

FDA approval span

First approval

Dec 14, 1990

36 yr 4 mo ago

Most recent approval

Aug 18, 2026

1 mo ago

Approvals span 1990–2026 across 36 FDA applications.

Brand (NDA) 1131%

Generic (ANDA) 2569%

Fluticasone propionate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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