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Last Updated: June 5, 2020

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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.

Drug Prices for fluocinolone acetonide

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Recent Clinical Trials for fluocinolone acetonide

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

SponsorPhase
Pradeepa YoganathanPhase 2
St. Michael's Hospital, TorontoPhase 2
Alimera SciencesPhase 4

See all fluocinolone acetonide clinical trials

Pharmacology for fluocinolone acetonide
Medical Subject Heading (MeSH) Categories for fluocinolone acetonide
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

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

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

Supplementary Protection Certificates for fluocinolone acetonide

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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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Dow
Moodys

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