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Last Updated: May 28, 2020

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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 freedom to operate?

Fluocinonide is the generic ingredient in five branded drugs marketed by Acp Nimble, Amneal Pharms Llc, Cadila, 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, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Zydus Pharms, and is included in forty-six 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. Thirty-three 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

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SponsorPhase
Valeant Pharmaceuticals International, Inc.N/A
Rochester General HospitalN/A
Rochester Skin Lymphoma Medical Group, PLLCN/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
Acp Nimble FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 074204-001 Jun 13, 1995 AB2 RX No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 206003-001 Jul 21, 2017 AT RX No No   Start Trial   Start Trial   Start Trial
Taro FLUOCINONIDE fluocinonide CREAM;TOPICAL 071500-001 Jun 10, 1987 AB1 RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc FLUOCINONIDE fluocinonide CREAM;TOPICAL 211111-001 Jun 4, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 209283-001 Apr 23, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Medicis VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 OINTMENT;TOPICAL 016909-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
McKesson
Dow
Johnson and Johnson
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.