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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, Perrigo New York, Pharmaderm, 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, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in seventy-three 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-five patent family members in twenty-seven countries.
There are twelve drug master file entries for fluocinolone acetonide. Twenty-seven suppliers are listed for this compound.
Summary for fluocinolone acetonide
International Patents: | 185 |
US Patents: | 13 |
Tradenames: | 17 |
Applicants: | 27 |
NDAs: | 73 |
Drug Master File Entries: | 12 |
Suppliers / Packagers: | 27 |
Bulk Api Vendors: | 61 |
Clinical Trials: | 28 |
Patent Applications: | 6,172 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for fluocinolone acetonide |
DailyMed Link: | fluocinolone acetonide at DailyMed |
Recent Clinical Trials for fluocinolone acetonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. Michael's Hospital, Toronto | Phase 2 |
Pradeepa Yoganathan | Phase 2 |
Alimera Sciences | Phase 4 |
Pharmacology for fluocinolone acetonide
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 |
(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.-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 |
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 |
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 (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) |
Fluocinolon acetonid |
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) |
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 |
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 |
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 |
Radiocin |
Retisert |
Retisert (TN) |
RL04590 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lyne | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 203377-001 | Apr 25, 2016 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Identi Pharms Inc | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 201759-001 | Oct 17, 2011 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Medimetriks Pharms | SYNALAR | fluocinolone acetonide | OINTMENT;TOPICAL | 013960-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Pharmafair | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 088449-001 | Feb 8, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Identi Pharms Inc | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL/DROPS;OTIC | 091306-001 | Oct 17, 2011 | 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 |
---|---|---|---|---|---|---|---|
Bausch And Lomb | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | Start Trial | Start Trial |
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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluocinolone acetonide
Country | Patent Number | Estimated Expiration |
---|---|---|
Poland | 1696822 | Start Trial |
Japan | 2006516621 | Start Trial |
Japan | 2006514658 | Start Trial |
Denmark | 1696822 | Start Trial |
Taiwan | 201422269 | Start Trial |
>Country | >Patent Number | >Estimated 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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