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RETISERT Drug Profile

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When do Retisert patents expire, and when can generic versions of Retisert launch?

Retisert is a drug marketed by Bausch And Lomb and is included in one NDA. There are two patents protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in RETISERT is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for RETISERT

International Patents:	10
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	54
Clinical Trials:	8
Patent Applications:	3,964
Formulation / Manufacturing:	see details
DailyMed Link:	RETISERT at DailyMed

Pharmacology for RETISERT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for RETISERT

Anti-Inflammatory Agents

Glucocorticoids

Synonyms for RETISERT

(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

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 (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 RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes			Y
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes			Y

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Non-Orange Book US Patents for RETISERT

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
8,252,307	Method for treating and/or preventing retinal diseases with sustained release corticosteroids

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International Patents for RETISERT

Country	Document Number	Estimated Expiration
Australia	777727
South Korea	20010112357
European Patent Office	1162978
Australia	4174800