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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-four suppliers are listed for this compound.

Summary for fluocinolone acetonide

International Patents:	183
US Patents:	9
Tradenames:	14
Applicants:	25
NDAs:	67
Drug Master File Entries:	12
Suppliers / Packagers:	24
Bulk Api Vendors:	59
Clinical Trials:	154
Patent Applications:	5,940
Formulation / Manufacturing:	see details
DailyMed Link:	fluocinolone acetonide at DailyMed

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[10.8.0.0(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
G And W Labs Inc	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	207441-001	Sep 28, 2016		DISCN	No	No
Pharmaderm	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OINTMENT;TOPICAL	088046-001	Dec 16, 1982		DISCN	No	No
G And W Labs	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089526-001	Jul 26, 1988	AT	RX	No	No
Galderma Labs Lp	CAPEX	fluocinolone acetonide	SHAMPOO;TOPICAL	020001-001	Aug 27, 1990		RX	Yes	Yes

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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
8,574,613	Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof
8,574,659	Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof
8,815,284	Bioerodible sustained release drug delivery systems

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International Patents for fluocinolone acetonide

Country	Document Number	Estimated Expiration
Spain	2315282
European Patent Office	1982701
Canada	2484632
Canada	2367092

Supplementary Protection Certificates for fluocinolone acetonide

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