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Last Updated: October 16, 2019

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Fluocinonide - Generic Drug Details

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What are the generic drug sources for fluocinonide and what is the scope of patent protection?

Fluocinonide is the generic ingredient in five branded drugs marketed by Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent Pharma Inc, Teva, Fougera Pharms, Taro Pharm Inds Ltd, Cnty Line Pharms, Medicis, Novel Labs Inc, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Zydus Pharms, and is included in forty-four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluocinonide has eleven patent family members in nine countries.

There are nine drug master file entries for fluocinonide. Forty suppliers are listed for this compound.

Drug Prices for fluocinonide

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Drug Sales Revenue Trends for fluocinonide

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Recent Clinical Trials for fluocinonide

Identify potential brand extensions & 505(b)(2) entrants

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
AC1L1TI1
AKOS015896516
API0002731
BC214760
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
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
Fluzon
GTPL7078
HMS1570K10
HMS2097K10
HMS2234H04
HMS3259N05
HMS3714K10
HY-B0485
I06-2489
Lidex
LIDEX (TN)
Lidex E
LIDEX-E
Lonide
LS-118446
Lyderm
Metosyn
MFCD00079302
MLS000028476
MolPort-002-528-921
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
RL03345
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

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
Taro FLUOCINONIDE fluocinonide GEL;TOPICAL 074935-001 Jul 29, 1997 AB RX No Yes   See Pricing   See Pricing   See Pricing
Macleods Pharms Ltd FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 209283-001 Apr 23, 2018 AT RX No No   See Pricing   See Pricing   See Pricing
Teligent Pharma Inc FLUOCINONIDE fluocinonide CREAM;TOPICAL 211758-001 Apr 3, 2019 AB RX No No   See Pricing   See Pricing   See Pricing
Fougera Pharms Inc FLUOCINONIDE fluocinonide GEL;TOPICAL 072933-001 Dec 30, 1994 AB RX No No   See Pricing   See Pricing   See Pricing
Novel Labs Inc FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 207538-001 Jul 31, 2017 AB RX No No   See Pricing   See Pricing   See Pricing
Fougera Pharms Inc FLUOCINONIDE fluocinonide CREAM;TOPICAL 073030-001 Oct 17, 1994 AB1 RX No No   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fluocinonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   See Pricing   See Pricing
Cnty Line Pharms LIDEX fluocinonide OINTMENT;TOPICAL 016909-002 Approved Prior to Jan 1, 1982   See Pricing   See Pricing
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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