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Fluocinonide - Generic Drug Details

What are the generic drug sources for fluocinonide and what is the scope of fluocinonide patent protection?
Fluocinonide is the generic ingredient in five branded drugs marketed by Fougera Pharms Inc, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teva, Fougera Pharms, Cnty Line Pharms, Medicis, Novel Labs Inc, Glasshouse Pharms, Macleods Pharms Ltd, and Teva Pharms, and is included in thirty-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-two suppliers are listed for this compound.

Summary for fluocinonide

International Patents:	11
US Patents:	4
Tradenames:	5
Applicants:	14
NDAs:	35
Drug Master File Entries:	9
Suppliers / Packagers:	32
Bulk Api Vendors:	51
Clinical Trials:	8
Patent Applications:	6,092
Formulation / Manufacturing:	see details
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

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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
Fougera Pharms	FLUOCINONIDE EMULSIFIED BASE	fluocinonide	CREAM;TOPICAL	076586-001	Jun 23, 2004	AB2	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Taro	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	072857-001	Aug 2, 1989		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
G And W Labs Inc	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	073085-001	Feb 14, 1992	AB1	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Medicis	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	AB	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial	Y			➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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

Non-Orange Book US Patents for fluocinonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
7,217,422	Compositions and methods for enhancing corticosteroid delivery	➤ Try a Free Trial
7,771,733	Compositions and methods for enhancing corticosteroid delivery	➤ Try a Free Trial
Patent No.	Title	Estimated Patent Expiration