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Last Updated: June 21, 2024

FLUOCINOLONE ACETONIDE - Generic Drug Details


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

Fluocinolone acetonide is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Allied, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Patrin, Amneal, Lyne, Padagis Israel, Quagen, Saptalis Pharms, Tasman Pharma, Glenmark Pharms Ltd, Novel Labs Inc, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in seventy-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and seventy-seven patent family members in twenty-seven countries.

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

Summary for FLUOCINOLONE ACETONIDE
Drug Prices for FLUOCINOLONE ACETONIDE

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Recent Clinical Trials for FLUOCINOLONE ACETONIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Eye Institute (NEI)Phase 3
Jaeb Center for Health ResearchPhase 3
Genentech, Inc.Phase 3

See all FLUOCINOLONE ACETONIDE clinical trials

Pharmacology for FLUOCINOLONE ACETONIDE
Medical Subject Heading (MeSH) Categories for FLUOCINOLONE ACETONIDE

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
Savage Labs FLUOTREX fluocinolone acetonide CREAM;TOPICAL 088173-001 Mar 9, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Perrigo New York FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 086810-001 Mar 4, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hill Dermac DERMA-SMOOTHE/FS fluocinolone acetonide OIL;TOPICAL 019452-001 Feb 3, 1988 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 040042-001 Oct 31, 1994 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Quagen FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 212762-001 Apr 2, 2021 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 040041-001 Sep 15, 1994 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 206422-001 Sep 2, 2015 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 ⤷  Sign Up ⤷  Sign Up
Alimera Sciences Inc YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 ⤷  Sign Up ⤷  Sign Up
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 ⤷  Sign Up ⤷  Sign Up
Alimera Sciences Inc YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 ⤷  Sign Up ⤷  Sign Up
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FLUOCINOLONE ACETONIDE

Country Patent Number Title Estimated Expiration
Australia 2004207506 ⤷  Sign Up
European Patent Office 2044959 Système de livraison de médicament coagulant in situ (In-situ gelling drug delivery system) ⤷  Sign Up
Norway 20062362 ⤷  Sign Up
Slovenia 1592407 ⤷  Sign Up
Taiwan I445559 ⤷  Sign Up
Taiwan 200509998 Controlled release of highly soluble agents ⤷  Sign Up
Japan 2007537977 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLUOCINOLONE ACETONIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2233112 122014000063 Germany ⤷  Sign Up PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112 132014902285293 Italy ⤷  Sign Up PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.