Is there a generic for Fluocinolone acetonide?

Yes. The FDA Orange Book lists 68 approved generic (ANDA) applications for Fluocinolone acetonide, referencing the brand YUTIQ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluocinolone acetonide?

YUTIQ (NDA 210331, ALIMERA SCIENCES INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Fluocinolone acetonide?

The Orange Book lists 3 patents against Fluocinolone acetonide products, with the earliest listed expiry in 2027. 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.

What dosage forms of Fluocinolone acetonide are approved?

Fluocinolone acetonide is approved in the following dosage forms: cream, gel, implant, oil, oil/drops, ointment, shampoo, solution.

FDA Orange Book · active-ingredient family

Fluocinolone acetonide

Fluocinolone acetonide: 9 brands, 68 generics; first approved Mar 04, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 68 ANDA applications approved.

Earliest patent expiry Aug 12, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 12, 2027

in 10 mo

Brand (NDA) products

Originator applications

YUTIQRLDRS
ALIMERA SCIENCES INCNDA 2103312018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.18MG IMPLANT INTRAVITREAL Rx —
ILUVIENRLDRS
ALIMERA SCIENCES INCNDA 2019232014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.19MG IMPLANT INTRAVITREAL Rx —
DERMOTICRLDRS
HILL DERMACNDA 01945220053 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
0.01% OIL TOPICAL Rx AT
0.01% OIL/DROPS OTIC Rx AT
RETISERTRLD
BAUSCH AND LOMBNDA 0217372005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.59MG IMPLANT INTRAVITREAL Discontinued —
CAPEXRLD
GALDERMA LABS LPNDA 0200011990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SHAMPOO TOPICAL Discontinued —
SYNALARRLDRS
EUROFARMANDA 012787—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Rx AT
0.01% CREAM TOPICAL Rx AT
0.025% CREAM TOPICAL Rx AT
SYNALARRLDRS
EUROFARMANDA 013960—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Rx AT
SYNALARRLDRS
EUROFARMANDA 015296—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
SYNALAR-HP
EUROFARMANDA 016161—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% CREAM TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.18MG	IMPLANT	INTRAVITREAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.19MG	IMPLANT	INTRAVITREAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT
0.01%	OIL	TOPICAL	Rx	AT
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.59MG	IMPLANT	INTRAVITREAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SHAMPOO	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Rx	AT
0.01%	CREAM	TOPICAL	Rx	AT
0.025%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	CREAM	TOPICAL	Discontinued	—

Generic (ANDA) products (68)

Abbreviated applications

FLUOCINOLONE ACETONIDE
NOVEL LABS INCANDA 2073472023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
NOVEL LABS INCANDA 2073452023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
QUAGENANDA 2127622021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Rx AT
FLUOCINOLONE ACETONIDE
QUAGENANDA 2127602021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
QUAGENANDA 2127612021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
TP ANDA HOLDINGSANDA 2132642021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Rx AT
FLUOCINOLONE ACETONIDE
ENCUBE ETHICALSANDA 2099132019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
FLUOCINONIDE ACETONIDE
GLENMARK PHARMS LTDANDA 2118152018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Discontinued —
FLUOCINOLONE ACETONIDE
COSETTE PHARMS NCANDA 2107472018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Rx AT
FLUOCINONIDE ACETONIDE
GLENMARK PHARMS LTDANDA 2105392018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
GLENMARK PHARMS LTDANDA 2105562018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Discontinued —
FLAC
ANDA REPOSITORYANDA 2107362018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Rx AT
FLUOCINOLONE ACETONIDE
CHARTWELL RXANDA 2095962017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
PADAGIS ISRAELANDA 2028492017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Rx AT
FLUOCINOLONE ACETONIDE
ACTAVIS LABS UT INCANDA 2083862016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
COSETTE PHARMS NCANDA 2074412016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SCIEGEN PHARMSANDA 2027052016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 2023682016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 2093362016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
RISINGANDA 2033782016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Rx AT
FLUOCINOLONE ACETONIDE
RISINGANDA 0909822016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
RISINGANDA 2033772016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
LUPINANDA 2064222015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
SCIEGEN PHARMSANDA 0915142015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PADAGIS ISRAELANDA 2028472013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
PADAGIS ISRAELANDA 2028482013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
AMNEALANDA 0913062011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL/DROPS OTIC Discontinued —
FLUOCINOLONE ACETONIDE
AMNEALANDA 2017592011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
AMNEALANDA 2017642011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% OIL TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0400351994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0400421994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0400411994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
BAUSCH AND LOMBANDA 0400591993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
COSETTE PHARMS NCANDA 0895261988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
COSETTE PHARMS NCANDA 0895251988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
COSETTE PHARMS NCANDA 0895241988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0891241985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
USL PHARMAANDA 0887561985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
USL PHARMAANDA 0887571985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
USL PHARMAANDA 0887421985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUONID
ALLERGAN HERBERTANDA 0871561984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUONID
ALLERGAN HERBERTANDA 0871571984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PHARMAFAIRANDA 0884991984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PHARMAFAIRANDA 0885061984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PHARMAFAIRANDA 0885071984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PHARMAFAIRANDA 0884491984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PAI HOLDINGS PHARMANDA 0883121984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCET
ALPHARMA US PHARMSANDA 0883601984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMSANDA 0883611984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOTREX
SAVAGE LABSANDA 0881741983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUONID
ALLERGAN HERBERTANDA 0871581983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOTREX
SAVAGE LABSANDA 0881731983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOTREX
SAVAGE LABSANDA 0881721983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUOTREX
SAVAGE LABSANDA 0881711983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
ALLIEDANDA 0880471982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
FOUGERA PHARMS INCANDA 0881701982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
FOUGERA PHARMS INCANDA 0881691982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
INVATECHANDA 0880451982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
FOUGERA PHARMS INCANDA 0881681982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
PHARMADERMANDA 0880461982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% OINTMENT TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
ALLIEDANDA 0880481982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
FOUGERA PHARMS INCANDA 0881671982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Rx AT
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMSANDA 0871591982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION TOPICAL Discontinued —
FLUONID
ALLERGAN HERBERTANDA 0873001982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% GEL TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0871021982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
SUN PHARMA CANADAANDA 0871041982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PERRIGO NEW YORKANDA 0868101982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM TOPICAL Discontinued —
FLUOCINOLONE ACETONIDE
PERRIGO NEW YORKANDA 0868111982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% CREAM TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL/DROPS	OTIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	OIL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	CREAM	TOPICAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

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
8871241	Aug 12, 2027	in 10 mo	Product
7998108	Jan 12, 2028	in 1 yr 3 mo	ProductU-3410
9849027	Nov 07, 2028	in 2 yr 1 mo	ProductU-708

Approval history

FDA approval span

First approval

Mar 04, 1982

45 yr 3 mo ago

Most recent approval

Aug 07, 2023

3 yr 3 mo ago

Approvals span 1982–2023 across 77 FDA applications.

Brand (NDA) 912%

Generic (ANDA) 6888%

Fluocinolone acetonide: 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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