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Serving hundreds of leading biopharmaceutical companies globally:

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Cipla
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Dow
Deloitte
Teva
Fuji
Harvard Business School
Chubb

Generated: August 15, 2018

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Fluocinolone acetonide - Generic Drug Details

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What are the generic drug sources for fluocinolone acetonide and what is the scope of fluocinolone acetonide patent protection?

Fluocinolone acetonide is the generic ingredient in fourteen branded drugs marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Patrin Pharma Inc, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Galderma Labs Lp, Actavis Labs Ut Inc, G And W Labs Inc, Gavis Pharms Llc, Glasshouse Pharms, and Morton Grove, and is included in sixty-seven NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and eighty-three patent family members in twenty-six countries.

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

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[10.8.0.0(2),?.0?,?.0(1)(3),(1)?]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-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
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.-h
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.alpha.,9-Difluoro-11.beta.,16.alpha.,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone
6.alpha.,9.alpha.-Difluoro-16.alpha.-hydroxyprednisolone 16,17-acetonide
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
6a,9a-difluoro-16a-hydroxyprednisolone 16,17-acetonide
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
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
AC1L1M1L
AC1Q6ACL
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
BC214761
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
D02QJH
DB00591
Derma-smoothe/fs
Dermalar
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
Flucort-N (TN)
Fluocet
Fluocet (TN)
Fluocinolon acetonid
Fluocinolonacetonid
Fluocinolonacetonidum
Fluocinolone (Acetonide)
Fluocinolone 16,17-acetonide
Fluocinolone acetonide (Flucort-N)
Fluocinolone acetonide (JP15/USP/INN)
Fluocinolone acetonide (JP17/USP/INN)
Fluocinolone acetonide [DCIT]
Fluocinolone acetonide [USAN:INN:JAN]
Fluocinolone acetonide [USAN:USP:INN:JAN]
fluocinolone acetonide dihydrate
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 oil
Fluocinolone acetonide, analytical standard
Fluocinolone acetonide, European Pharmacopoeia (EP) Reference Standard
Fluocinolone Acetonide, pharmaceutical secondary standard; traceable to USP, PhEur and BP
Fluocinolone acetonide, United States Pharmacopeia (USP) Reference Standard
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
HSDB 3083
HY-B0415
Iluvien
J10113
Jellin
Localyn
Localyn Syntex
LS-118443
Medidur
MFCD00010525
MLS000028545
MLS001076276
MolPort-002-528-328
NC00562
NCGC00021301-04
NCGC00021301-06
NCGC00255654-01
NCI60_042042
Neo-Synalar
NSC 92339
NSC-92339
NSC92339
Omniderm
Opera_ID_1295
Percutina
PL000407
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, 6.alpha.,9-difluoro-11.beta.,16.alpha.,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
Pregna-1,4-diene-3,20-dione, 6alpha,9-difluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone (8CI)
Prodermin
Radiocin
Retisert
Retisert (TN)
RL04590
RS 1401AT
RS-1401 AT
s2470
SCHEMBL4795
Sinalar
SMR000058329
SR-01000000109
SR-01000000109-2
STOCK1N-55828
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
ydroxyprednisolone 16,17-acetonide
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
Usl Pharma FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 088742-001 Feb 8, 1985 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Medimetriks Pharms SYNALAR fluocinolone acetonide CREAM;TOPICAL 012787-004 Approved Prior to Jan 1, 1982 AT RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Akorn FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 091514-001 Jun 25, 2015 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alpharma Us Pharms FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 087159-001 Jun 16, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Non-Orange Book US Patents for fluocinolone acetonide

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.

Patent No. Title Estimated Patent Expiration
7,439,249 Inhibitors of phosphatases ➤ Try a Free Trial
8,574,613 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Try a Free Trial
8,574,659 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Try a Free Trial
8,815,284 Bioerodible sustained release drug delivery systems ➤ Try a Free Trial
9,192,579 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Try a Free Trial
9,566,336 In situ gelling drug delivery system ➤ Try a Free Trial
9,849,085 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for fluocinolone acetonide

Country Document Number Estimated Expiration
Spain 2379466 ➤ Try a Free Trial
Slovenia 1592407 ➤ Try a Free Trial
Japan 2006514658 ➤ Try a Free Trial
China 1741793 ➤ Try a Free Trial
South Africa 200208415 ➤ Try a Free Trial
Taiwan 200514581 ➤ Try a Free Trial
China 1901850 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for fluocinolone acetonide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000063 Germany ➤ Try a Free Trial PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
AstraZeneca
Baxter
Colorcon
Daiichi Sankyo
Covington
Moodys
US Department of Justice

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