Is there a generic for Clobetasol propionate?

Yes. The FDA Orange Book lists 87 approved generic (ANDA) applications for Clobetasol propionate, referencing the brand BYQLOVI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clobetasol propionate?

BYQLOVI (NDA 218158, HARROW EYE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Clobetasol propionate?

The Orange Book lists 8 patents against Clobetasol propionate products, with the earliest listed expiry in 2028. 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 Clobetasol propionate have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Clobetasol 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 Clobetasol propionate are approved?

Clobetasol propionate is approved in the following dosage forms: aerosol, foam, cream, gel, lotion, ointment, shampoo, solution, spray, suspension/drops.

FDA Orange Book · active-ingredient family

Clobetasol propionate

Clobetasol propionate: 13 brands, 87 generics; first approved Dec 27, 1985; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 87 ANDA applications approved.

Earliest patent expiry Nov 05, 2028Latest exclusivity ends Mar 04, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 05, 2028

in 2 yr 3 mo

Brand (NDA) products

Originator applications

BYQLOVIRLDRS
HARROW EYENDA 2181582024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SUSPENSION/DROPS OPHTHALMIC Rx —
IMPEKLORLD
PHARMOBEDIENTNDA 2136912020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
IMPOYZRLDRS
PRIMUS PHARMSNDA 2094832017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Rx —
OLUX ERLD
PHARMOBEDIENTNDA 0220132007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued —
CLOBEXRLDRS
GALDERMA LABS LPNDA 0218352005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Rx AT
CLOBEXRLDRS
GALDERMA LABSNDA 0216442004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Rx AB
CLOBEXRLDRS
GALDERMA LABS LPNDA 0215352003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
OLUXRLD
PHARMOBEDIENTNDA 0211422000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued —
TEMOVATE ERLD
FOUGERA PHARMSNDA 0203401994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
TEMOVATERLD
FOUGERA PHARMSNDA 0203371994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Discontinued —
TEMOVATERLD
FOUGERA PHARMSNDA 0199661990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
TEMOVATERLD
FOUGERA PHARMSNDA 0193221985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
TEMOVATERLD
FOUGERA PHARMSNDA 0193231985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SUSPENSION/DROPS	OPHTHALMIC	Rx	—

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
0.025%	CREAM	TOPICAL	Rx	—

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

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	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%	GEL	TOPICAL	Discontinued	—

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

Generic (ANDA) products (87)

Abbreviated applications

CLOBETASOL PROPIONATE
XIROMEDANDA 2106382025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
MACLEODS PHARMS LTDANDA 2143452024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
TAROANDA 2085632024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
MACLEODS PHARMS LTDANDA 2159902023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
ALEMBICANDA 2158382022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
QUAGENANDA 2112402022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATE
AMNEALANDA 2148952021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Rx AB
CLOBETASOL PROPIONATE
CHARTWELL RXANDA 2112072021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 2148672021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Rx AB
CLOBETASOL PROPIONATE
PRINSTON INCANDA 2131392021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
CLOBETASOL PROPIONATERS
ENCUBEANDA 2129822020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
ALEMBICANDA 2132902020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Rx AB
CLOBETASOL PROPIONATE
ALEMBICANDA 2132912020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
TORRENTANDA 2118362019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATERS
ENCUBEANDA 2112952019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
TORRENTANDA 2129262019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ALEMBICANDA 2128812019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATE
SAPTALIS PHARMSANDA 2114942019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATE
ALEMBICANDA 2111912019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Rx AT
CLOBETASOL PROPIONATE
ZYDUS LIFESCIENCESANDA 2052492019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
CLOBETASOL PROPIONATE
GLENMARK PHARMS LTDANDA 2114502019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB2
CLOBETASOL PROPIONATE
ALEMBICANDA 2118002019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
GLENMARK PHARMS LTDANDA 2108092019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
PAI HOLDINGS PHARMANDA 2085892019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
RISINGANDA 2114012019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
AMNEALANDA 2112562018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
EPIC PHARMA LLCANDA 2113482018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ZYDUS PHARMSANDA 2110742018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATERS
TAROANDA 2087792018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
AMNEALANDA 2105512018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
XIROMEDANDA 2100342018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
GLENMARK SPECLTANDA 2090952018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
NOVEL LABS INCANDA 2088412018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
GLENMARK PHARMS LTDANDA 2101902018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
CLOBETASOL PROPIONATE
PAI HOLDINGS PHARMANDA 2099742018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
XIROMEDANDA 2097012018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
APOTEXANDA 2104462018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
GLENMARK SPECLTANDA 2090042018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
LUPINANDA 2081252018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 2088422018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Rx AT
CLOBETASOL PROPIONATE
LUPINANDA 2102082018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
ZYDUS PHARMSANDA 2101992017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
HIKMAANDA 2098712017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Discontinued —
CLOBETASOL PROPIONATE
MACLEODS PHARMS LTDANDA 2093612017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATE
LUPINANDA 2091472017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
CLOBETASOL PROPIONATE (EMOLLIENT)
BEACH PRODSANDA 2094112017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB2
CLOBETASOL PROPIONATE
INGENUS PHARMS LLCANDA 2068052017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
SCIEGEN PHARMSANDA 2072182017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
GLENMARK SPECLTANDA 2089332017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ENCUBEANDA 2088812017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ZYDUS PHARMSANDA 2063782017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Rx AT
CLOBETASOL PROPIONATE
BEACH PRODSANDA 2086672016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
CLOBETASOL PROPIONATE
NOVEL LABS INCANDA 2060752015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATERS
PADAGIS ISRAELANDA 2014022012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB2
CLOBETASOL PROPIONATE
PADAGIS ISRAELANDA 0909742012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Rx AB
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 2003022012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
CLOBETASOL PROPIONATE
PADAGIS USANDA 0908982011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SPRAY TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTICANDA 0788542011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SHAMPOO TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTICANDA 0782232008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
CLOBETASOL PROPIONATE
PADAGIS ISRAELANDA 0777632008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
ENCUBEANDA 0769772005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
EMBELINE
HIKMAANDA 0761412002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Discontinued —
CLOBETASOL PROPIONATE (EMOLLIENT)
ANI PHARMSANDA 0757332001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
AUROBINDO PHARMA USAANDA 0753382001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0753632000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
CLOBETASOL PROPIONATE (EMOLLIENT)
SUN PHARMA CANADAANDA 0756332000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB2
CLOBETASOL PROPIONATERS
FOUGERA PHARMSANDA 0753682000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Rx AB
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0752791999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Rx AB
CLOBETASOL PROPIONATE (EMOLLIENT)RS
FOUGERA PHARMSANDA 0754301999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB2
CLOBETASOL PROPIONATE
FOUGERA PHARMSANDA 0753911999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
EMBELINE E
HIKMAANDA 0753251998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATERS
SUN PHARMA CANADAANDA 0752241998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Rx AT
CLOBETASOL PROPIONATE
WOCKHARDT BIO AGANDA 0752051998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
CLOBETASOL PROPIONATE
AUROBINDO PHARMA USAANDA 0750571998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
PADAGIS USANDA 0750271997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Rx AB
CORMAX
HIKMAANDA 0742201997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
FOUGERA PHARMS INCANDA 0743921996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0742481996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0742491996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB1
CLOBETASOL PROPIONATE
FOUGERA PHARMSANDA 0744071996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
CLOBETASOL PROPIONATE
COSETTE PHARMS NCANDA 0743311995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
EMBELINE
HIKMAANDA 0742221995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% SOLUTION TOPICAL Discontinued —
EMBELINE
HIKMAANDA 0742211995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
COSETTE PHARMS NCANDA 0741391994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTICANDA 0741281994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
CLOBETASOL PROPIONATE
TEVA PHARMS USAANDA 0740871994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
CLOBETASOL PROPIONATE
COSETTE PHARMS NCANDA 0740891994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Rx	AB1

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Rx	AB1

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

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

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%	SHAMPOO	TOPICAL	Rx	AB

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

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

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

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

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Rx	AB2

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Rx	AB1

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

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
0.05%	CREAM	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Rx	AB1

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

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%	OINTMENT	TOPICAL	Rx	AB

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

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

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Mar 04, 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
8460641	Nov 05, 2028	in 2 yr 3 mo	ProductU-1410
10064875	Aug 31, 2030	in 4 yr 1 mo	ProductU-88
9956231	Aug 31, 2030	in 4 yr 1 mo	ProductU-88
11179465	Aug 31, 2030	in 4 yr 1 mo	ProductU-1858
10588914	Aug 31, 2030	in 4 yr 1 mo	ProductU-2771
9855334	Mar 11, 2035	in 8 yr 8 mo	Product
11376262	May 09, 2036	in 9 yr 10 mo	ProductU-19
10588913	May 09, 2036	in 9 yr 10 mo	Product

Approval history

FDA approval span

First approval

Dec 27, 1985

41 yr 3 mo ago

Most recent approval

Nov 20, 2025

9 mo ago

Approvals span 1985–2025 across 100 FDA applications.

Brand (NDA) 1313%

Generic (ANDA) 8787%

Clobetasol 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.

Related FDA reference tools

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

Book a Demo