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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 fluocinolone acetonide freedom to operate?

Fluocinolone acetonide is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, G And W Labs Inc, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Eyepoint Pharms, Hill Dermac, Patrin Pharma Inc, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Glenmark Pharms Ltd, Galderma Labs Lp, Actavis Labs Ut Inc, Gavis Pharms Llc, Glasshouse Pharms, and Morton Grove, and is included in seventy-one NDAs. There are thirteen 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:	13
Tradenames:	17
Applicants:	27
NDAs:	71
Drug Master File Entries:	12
Suppliers / Packagers:	24
Bulk Api Vendors:	58
Clinical Trials:	27
Patent Applications:	6,015
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for fluocinolone acetonide
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
Taro	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	087102-001	Apr 27, 1982		DISCN	No	No
Glenmark Pharms Ltd	FLUCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	210556-001	Oct 25, 2018	AT	RX	No	No
Savage Labs	FLUOTREX	fluocinolone acetonide	CREAM;TOPICAL	088174-001	May 6, 1983		DISCN	No	No
Perrigo New York	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	086810-001	Mar 4, 1982		DISCN	No	No
G And W Labs	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OINTMENT;TOPICAL	089524-001	Jul 26, 1988	AT	RX	No	No
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018		RX	Yes	Yes			Y
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014		RX	Yes	Yes			Y

International Patents for fluocinolone acetonide

Country	Document Number	Estimated Expiration
Argentina	042920
New Zealand	581461
Taiwan	200515919
Norway	20062362
World Intellectual Property Organization (WIPO)	2004066979
Canada	2484632
Austria	440595

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