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Last Updated: February 29, 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 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, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Zydus Pharms, and is included in forty-five 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-five suppliers are listed for this compound.

Summary for fluocinonide

International Patents:	11
US Patents:	4
Tradenames:	5
Applicants:	20
NDAs:	45
Drug Master File Entries:	9
Suppliers / Packagers:	35
Bulk Api Vendors:	54
Clinical Trials:	8
Patent Applications:	5,635
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluocinonide
Drug Sales Revenues:	Drug sales revenues for fluocinonide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluocinonide
DailyMed Link:	fluocinonide at DailyMed

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Drug Sales Revenue Trends for fluocinonide

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Recent Clinical Trials for fluocinonide

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Sponsor	Phase
Rochester General Hospital	N/A
Rochester Skin Lymphoma Medical Group, PLLC	N/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 Name	Date
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

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluocinonide

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	FLUOCINONIDE EMULSIFIED BASE	fluocinonide	CREAM;TOPICAL	072490-001	Feb 7, 1989	AB2	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
Taro	FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	075008-001	Jun 30, 1999	AB	RX	No	Yes	Start Trial	Start Trial				Start Trial
Taro Pharm Inds Ltd	FLUOCINONIDE EMULSIFIED BASE	fluocinonide	CREAM;TOPICAL	072494-001	Jan 19, 1989	AB2	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

Expired US Patents for fluocinonide

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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	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	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluocinonide

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Country	Patent Number	Estimated Expiration
European Patent Office	2363150	Start Trial
China	1617730	Start Trial
Brazil	0215254	Start Trial
Canada	2471041	Start Trial
>Country	>Patent Number	>Estimated Expiration

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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 verifification 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.

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