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.

Summary for fluocinonide

International Patents:	11
US Patents:	4
Tradenames:	5
Applicants:	19
NDAs:	44
Drug Master File Entries:	9
Suppliers / Packagers:	40
Bulk Api Vendors:	54
Clinical Trials:	8
Patent Applications:	5,826
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

See drug prices for fluocinonide

Drug Sales Revenue Trends for fluocinonide

See drug sales revenues for fluocinonide

Recent Clinical Trials for fluocinonide

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

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

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
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

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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	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

International Patents for fluocinonide

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Country	Patent Number	Estimated Expiration
Mexico	PA04006014	See Pricing
Canada	2471041	See Pricing
Australia	2002360589	See Pricing
World Intellectual Property Organization (WIPO)	03055445	See Pricing
European Patent Office	2363150	See Pricing
Japan	2005524614	See Pricing
>Country	>Patent Number	>Estimated Expiration

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