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Last Updated: April 3, 2020

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FLUOCINONIDE Drug Profile


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Which patents cover Fluocinonide, and when can generic versions of Fluocinonide launch?

Fluocinonide is a drug marketed by Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent Pharma Inc, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, Zydus Pharms, Glenmark Pharms Ltd, and Taro Pharm Inds Ltd. and is included in forty-three NDAs.

The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Drug patent expirations by year for FLUOCINONIDE
Drug Prices for FLUOCINONIDE

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Drug Sales Revenue Trends for FLUOCINONIDE

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Recent Clinical Trials for FLUOCINONIDE

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SponsorPhase
Rochester General HospitalN/A
Rochester Skin Lymphoma Medical Group, PLLCN/A
Valeant Pharmaceuticals International, Inc.N/A

See all FLUOCINONIDE clinical trials

Recent Litigation for FLUOCINONIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
MEDICIS PHARMACEUTICAL CORPORATION v. ZYDUS PHARMACEUTICALS (USA) INC.2016-03-21
Medicis Pharmaceutical Corporation v. Nycomed US Inc.2011-07-05
Medicis Pharmaceutical Corporation v. Nycomed US Inc.2010-12-15

See all FLUOCINONIDE litigation

Pharmacology for FLUOCINONIDE
Medical Subject Heading (MeSH) Categories for FLUOCINONIDE
Synonyms for FLUOCINONIDE
(6ALPHA,11BETA,16ALPHA)-21-(ACETYLOXY)-6,9-DIFLUORO-11-HYDROXY-16,17-[(1-METHYLETHYLIDENE)BIS(OXY)]-PREGNA-1,4-DIENE-3,20-DIONE
1,4-PREGNADIEN-6ALPHA,9ALPHA-DIFLUORO-11BETA,16ALPHA,17,21-TETROL-3,20-DIONE 16,17-ACETONIDE 21-ACETATE
2-((2S,6aS,6bR,7S,8aS,8bS,11aR,12aS,12bS)-2,6b-difluoro-7-hydroxy-6a,8a,10,10-tetramethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-yl)-2-oxoethyl acetate
2-[(1S,2S,4R,8S,9S,11S,12R,13S,19S)-12,19-difluoro-11-hydroxy-6,6,9,13-tetramethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.0^{2,9}.0^{4,8}.0^{13,18}]icosa-14,17-dien-8-yl]-2-oxoethyl acetate
20527-EP2371811A2
2W4A77YPAN
356-12-7
356F127
6alpha,9-Difluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone, 21-acetate
AB2000697
ABP000638
AC-2071
AKOS015896516
API0002731
BCP9000697
Bestasone
Biscosal
BPBio1_000934
BRD-K57886322-001-03-4
BRD-K57886322-001-12-5
BSPBio_000848
C07007
C26H32F2O7
CAS-356-12-7
CCG-220774
CHEBI:5109
CHEMBL1501
Cortalar
CS-2601
D00325
DB01047
DSSTox_CID_25307
DSSTox_GSID_45307
DSSTox_RID_80793
DTXSID8045307
EINECS 206-597-6
Fluocinolide
Fluocinolide acetate
Fluocinolone acetonide 21-acetate
Fluocinolone acetonide acetate
FLUOCINOMIDE ACETATE
Fluocinonide (JP17/USP/INN)
Fluocinonide (Vanos)
Fluocinonide [USAN:BAN:INN:JAN]
Fluocinonide [USAN:INN:BAN:JAN]
Fluocinonide [USAN:USP:INN:BAN:JAN]
FLUOCINONIDE ACETONIDE 21-ACETATE
Fluocinonide Emulsified Base
Fluocinonide FAPG
Fluocinonide, >=98% (HPLC)
Fluocinonide, micronised
Fluocinonide, United States Pharmacopeia (USP) Reference Standard
Fluocinonide(Vanos)
Fluocinonide(Vanos)/
Fluocinonido
Fluocinonido [INN-Spanish]
Fluocinonidum
Fluocinonidum [INN-Latin]
Fluonex
Fluonex;Lidex;Lidex-E;Lonide;Lyderm;Vanos
GTPL7078
HMS1570K10
HMS2097K10
HMS2234H04
HMS3259N05
HMS3714K10
HY-B0485
Lidex
LIDEX (TN)
Lidex E
LIDEX-E
Lonide
LS-118446
Lyderm
Metosyn
MFCD00079302
MLS000028476
NC00621
NCGC00016436-01
NCGC00022398-03
NCGC00022398-05
NSC 101791
Opera_ID_1780
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy))-, (6alpha,11beta,16alpha)-
Pregna-1,4-diene-3,20-dione, 6-alpha, 9-difluoro-11-beta,16-alpha,17,21-tetrahydroxy-, cyclic17-acetal with acetone, 21-acetate
Pregna-1,4-diene-3,20-dione, 6alpha,9-difluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone, 21-acetate
Pregna-1,4-diene-3,20-dione, 6alpha,9-difluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone, 21-acetate (8CI)
Prestwick_1066
Prestwick0_000774
Prestwick1_000774
Prestwick2_000774
Prestwick3_000774
Q5462791
s2608
SC-78862
SCHEMBL4262
SMR000058331
SPBio_002787
SR-01000003097
SR-01000003097-3
Straderm
Synalar acetate
Topsymin
Topsyn
Tox21_110438
Tox21_110438_1
UNII-2W4A77YPAN
Vanos
Vanos (TN)
W-106660
YF10077
ZINC3977978
Paragraph IV (Patent) Challenges for FLUOCINONIDE
Tradename Dosage Ingredient NDA Submissiondate
VANOS CREAM;TOPICAL fluocinonide 021758 2008-01-31
LIDEX OINTMENT;TOPICAL fluocinonide 016909

US Patents and Regulatory Information for FLUOCINONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 076586-001 Jun 23, 2004 AB2 RX No No   Start Trial   Start Trial   Start Trial
Taro FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 072857-001 Aug 2, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Fougera Pharms Inc FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 072934-001 Feb 27, 1995 AT RX No No   Start Trial   Start Trial   Start Trial
Taro FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 074799-001 Dec 31, 1996 AT RX No Yes   Start Trial   Start Trial   Start Trial
Glasshouse Pharms FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 209118-001 Apr 23, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Acp Nimble FLUOCINONIDE fluocinonide CREAM;TOPICAL 073085-001 Feb 14, 1992 AB1 RX No No   Start Trial   Start Trial   Start Trial
Taro FLUOCINONIDE fluocinonide GEL;TOPICAL 074935-001 Jul 29, 1997 AB RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Mallinckrodt
Express Scripts
Boehringer Ingelheim
Baxter

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