Fluocinolone acetonide - Generic Drug Details

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What are the generic sources for fluocinolone acetonide and what is the scope of freedom to operate?

Fluocinolone acetonide is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Acp Nimble, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Eyepoint Pharms, Hill Dermac, Anda Repository, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in seventy-three NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and seventy-six patent family members in twenty-seven countries.

There are twelve drug master file entries for fluocinolone acetonide. Twenty suppliers are listed for this compound.

Summary for fluocinolone acetonide

International Patents:	176
US Patents:	10
Tradenames:	17
Applicants:	28
NDAs:	73
Drug Master File Entries:	12
Suppliers / Packagers:	20
Bulk Api Vendors:	63
Clinical Trials:	28
Patent Applications:	6,179
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluocinolone acetonide
DailyMed Link:	fluocinolone acetonide at DailyMed

See drug prices for fluocinolone acetonide

Recent Clinical Trials for fluocinolone acetonide

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

Sponsor	Phase
Pradeepa Yoganathan	Phase 2
St. Michael's Hospital, Toronto	Phase 2
Alimera Sciences	Phase 4

See all fluocinolone acetonide clinical trials

Pharmacology for fluocinolone acetonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluocinolone acetonide

Anti-Inflammatory Agents
Glucocorticoids

Synonyms for fluocinolone acetonide

(1S,2S,4R,8S,9S,11S,12R,13S,19S)-12,19-difluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.0^{2,9}.0^{4,8}.0^{13,18}]icosa-14,17-dien-16-one
(1S,2S,4R,8S,9S,11S,12R,13S,19S)-12,19-difluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
(2S,6aS,6bR,7S,8aS,8bS,11aR,12aS,12bS)-2,6b-difluoro-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a,10,10-tetramethyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-4H-naphtho[
(2S,6aS,6bR,7S,8aS,8bS,11aR,12aS,12bS)-2,6b-difluoro-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a,10,10-tetramethyl-6a,6b,7,8,8a,8b,11a,12,12a,12b-decahydro-1H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4(2H)-one
(4aS,4bR,5S,6aS,6bS,9aR,10aS,10bS,12S)-4b,12-difluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
(4aS,4bR,5S,6aS,6bS,9aR,10aS,10bS,12S)-4b,12-Difluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
(4aS,4bR,5S,6aS,6bS,9aR,10aS,10bS,12S)-4b,12-difluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
(6alpha,11beta,16alpha)-6,9-Difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione
010F525
0CD5FD6S2M
2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one
4b,12-Difluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
6-alpha,9-alpha-Difluoro-16-alpha-hydroxyprednisolone 16,17-acetonide
6.alpha.-Fluorotriamcinolone acetonide
6.alpha., 9.alpha.-Difluoro-16.alpha.-hydroxyprednisolone 16,17-acetonide
6.alpha.,16.alpha.,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone
6.alpha.,17-acetonide
6.Alpha.,9-Difluoro
6\|A,9\|A-Difluoro-11\|A,16\|A,17\|A,21-tetrahydroxy-1,4-pregnadiene-3,20-dione 16,17-acetonide
67-73-2
6alpha-Fluorotriamcinolone acetonide
6alpha,9-Difluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone
6alpha,9alpha-Difluoro-11beta,16alpha,17alpha,21-tetrahydroxy-1,4-pregnadiene-3,20-dione 16,17-Acetonide
6alpha,9alpha-difluoro-11beta,21-dihydroxy-16alpha-17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione;
6alpha,9alpha-Difluoro-16alpha-hydroxyprednisolone 16,17-acetonide
AB00383017_11
AB00383017-10
AB1010906
AC-429
Acetonida de fluocinolona
Acetonida de fluocinolona [INN-Spanish]
Acetonide de fluocinolone
Acetonide de fluocinolone [INN-French]
acetonido de fluocinolona
ACN-043362
AKOS015963144
ARONIS24561
AS-13690
BRD-K94353609-001-21-6
C-22503
C24H30F2O6
Capex
CAS-67-73-2
CC-28473
CCG-221165
CCRIS 3250
CHEBI:31623
CHEMBL989
component of Neo-Synalar
Coriphate
Cortiplastol
CS-2519
D01825
DB00591
Derma-smoothe/fs
Dermalar
Dermatin
Dermatin (steroid)
difluoro-hydroxy-(2-hydroxyacetyl)-tetramethyl-[?]one
DSSTox_CID_20674
DSSTox_GSID_40674
DSSTox_RID_79533
DTXSID0040674
EBD4852
EINECS 200-668-5
F0657
FEBLZLNTKCEFIT-VSXGLTOVSA-N
Flucinar
flucinolone
Flucort
Flucort-N
Fluocet
Fluocet (TN)
Fluocinolonacetonidum
Fluocinolone (Acetonide)
Fluocinolone 16,17-acetonide
Fluocinolone acetonide (Flucort-N)
Fluocinolone acetonide (JP17/USP/INN)
Fluocinolone acetonide [DCIT]
Fluocinolone acetonide [USAN:INN:JAN]
Fluocinolone acetonide [USAN:USP:INN:JAN]
Fluocinolone acetonide for peak identification, European Pharmacopoeia (EP) Reference Standard
Fluocinolone acetonide for system suitability, European Pharmacopoeia (EP) Reference Standard
Fluocinolone acetonide intravitreal implant
Fluocinolone acetonide, analytical standard
Fluocinolone acetonide, European Pharmacopoeia (EP) Reference Standard
Fluocinolone Acetonide, Pharmaceutical Secondary Standard; Certified Reference Material
Fluocinolone acetonide, United States Pharmacopeia (USP) Reference Standard
Fluocinolone acetonide(Flucort-N)
Fluocinolone-acetonide(Flucort-N)
Fluocinoloneacetonide
Fluocinoloni acetonidum
Fluocinoloni acetonidum [INN-Latin]
Fluonid
Fluortriamcinolone Acetonide
Fluotrex
Fluovitif
Flupollon
Fluzon [Steroid]
Fs Shampoo
GTPL7077
HMS2090I14
HMS2230D13
HMS3259G12
HMS3715J11
HSDB 3083
HY-B0415
Iluvien
J10113
Jellin
Localyn
Localyn Syntex
LS-118443
MFCD00010525
MLS000028545
MLS001076276
NC00562
NCGC00021301-04
NCGC00021301-06
NCGC00255654-01
NCI60_042042
NSC 92339
NSC-92339
NSC92339
Omniderm
Opera_ID_1295
Percutina
Pregna-1,20-dione, 6,9-difluoro-11,12-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6.alpha.,11.beta.,16.alpha.)-
Pregna-1,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)-, (6.alpha.,11.beta.,16.alpha.)-
Pregna-1,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6.alpha.,11.beta.,16.alpha.)-
Pregna-1,20-dione, 6.alpha.,9-difluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,12-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (6-alpha,11-beta,16-alpha)-
Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (6alpha,11beta,16alpha)-
Pregna-1,4-diene-3,20-dione, 6alpha,9-difluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
Pregna-1,4-diene-3,20-dione, 6alpha,9-difluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone (8CI)
Prodermin
Q924467
Radiocin
Retisert
Retisert (TN)
RS 1401AT
RS-1401 AT
s2470
SCHEMBL4795
Sinalar
SMR000058329
SR-01000000109
SR-01000000109-2
Synalar
Synalar (TN)
Synalar-HP
Synamol
Synandone
Synandrone
Synemol
Synotic
Synsac
Tefunote
Tox21_110869
Tox21_110869_1
Tox21_302364
UNII-0CD5FD6S2M
W-104704
WLN: T F5 E5 B666 GO IO RV AHTTTT&J A BF CQ E FVIQ H H OF -A&BHO -B&ACEF
ZINC3977981

US Patents and Regulatory Information for fluocinolone acetonide

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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	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	087104-001	Apr 27, 1982	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Taro	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	087102-001	Apr 27, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Usl Pharma	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088756-001	Mar 28, 1985		DISCN	No	No	Start Trial	Start Trial				Start Trial
Glenmark Pharms Ltd	FLUOCINONIDE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	210539-001	Oct 26, 2018	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Medimetriks Pharms	SYNALAR-HP	fluocinolone acetonide	CREAM;TOPICAL	016161-002	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Fougera Pharms Inc	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	088167-001	Dec 16, 1982	AT	RX	No	No	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 fluocinolone acetonide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	Start Trial	Start Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	Start Trial	Start Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	Start Trial	Start Trial
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	Start Trial	Start Trial
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	Start Trial	Start Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluocinolone acetonide

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Country	Patent Number	Estimated Expiration
Australia	2003234439	Start Trial
China	100594899	Start Trial
European Patent Office	1592407	Start Trial
New Zealand	522002	Start Trial
Israel	152294	Start Trial
Norway	20062362	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for fluocinolone acetonide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	122014000063	Germany	Start Trial	PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112	132014902285293	Italy	Start Trial	PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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