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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 fluocinonide freedom to operate?

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

There are nine drug master file entries for fluocinonide. Thirty-eight suppliers are listed for this compound.

Summary for fluocinonide

US Patents:	4
Tradenames:	5
Applicants:	18
NDAs:	40
Drug Master File Entries:	9
Suppliers / Packagers:	38
Bulk Api Vendors:	50
Clinical Trials:	8
Patent Applications:	6,105
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for fluocinonide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluocinonide
DailyMed Link:	fluocinonide at DailyMed

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

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),?.0?,?.0(1)(3),(1)?]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

D03ZZK

DB01047

DSSTox_CID_25307

DSSTox_GSID_45307

DSSTox_RID_80793

DTXSID8045307

EINECS 206-597-6

flucetonide

Fluocinolide

Fluocinolide acetate

Fluocinolone acetonide 21-acetate

Fluocinolone acetonide acetate

Fluocinomide

FLUOCINOMIDE ACETATE

Fluocinonide (JP15/USP/INN)

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 (TN)

Fluonex;Lidex;Lidex-E;Lonide;Lyderm;Vanos

Fluzon

GTPL7078

HMS1570K10

HMS2097K10

HMS2234H04

HMS3259N05

HY-B0485

I06-2489

Lidex

LIDEX (TN)

Lidex E

LIDEX-E

Lidex-E (TN)

Lonide

Lonide (TN)

LS-118446

Lyderm

Lyderm (TN)

Metosyn

MFCD00079302

MLS000028476

MolPort-002-528-921

NC00621

NCGC00016436-01

NCGC00022398-03

NCGC00022398-05

NSC 101791

Opera_ID_1780

PL009845

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

STOCK1N-56641

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
Medicis	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	AB	RX	Yes	Yes			Y
Teva	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	072488-001	Feb 6, 1989	AB1	RX	No	No
Fougera Pharms Inc	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	200735-001	Jul 14, 2014	AB	RX	No	No
Teva Pharms	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	072522-001	Sep 28, 1990		DISCN	No	No
Zydus Pharms Usa Inc	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	208948-001	Jul 17, 2018	AT	RX	No	No
Teva	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	072511-001	Feb 7, 1989	AT	RX	No	No

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
Cnty Line Pharms	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982
Cnty Line Pharms	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982

International Patents for fluocinonide

Country	Document Number	Estimated Expiration
Japan	2010280689
Canada	2471041
China	1617730
Israel	162581
European Patent Office	2363150
European Patent Office	1465636