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Last Updated: January 30, 2023

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, Allied, Cosette, Fougera Pharms Inc, MLV, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Eyepoint Pharms, Hill Dermac, Anda Repository, Akorn, Amneal, Lyne, Padagis Israel, Quagen, Tasman Pharma, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Pai Holdings Pharm, and is included in seventy-seven NDAs. There are six 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-one 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
CBCC Global ResearchPhase 4
EyePoint Pharmaceuticals, Inc.Phase 4
Centre Hospitalier Universitaire DijonPhase 4

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
Usl Pharma FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 088757-001 Feb 11, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Savage Labs FLUOTREX fluocinolone acetonide SOLUTION;TOPICAL 088171-001 Mar 9, 1983 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 See Plans and Pricing See Plans and Pricing
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 See Plans and Pricing See Plans and Pricing
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fluocinolone acetonide

Country Patent Number Title Estimated Expiration
Mexico PA02010442 DISPOSITIVO DE ADMINISTRACION DE FARMACOS DE LIBERACION PROLONGADA, METODOS DE USO, Y METODOS DE FABRICACION DE LOS MISMOS. (SUSTAINED RELEASE DRUG DELIVERY DEVICES, METHODS OF USE, AND METHODS OF MANUFACTURING THEREOF.) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004066979 See Plans and Pricing
Poland 2233112 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112 132014902285293 Italy See Plans and Pricing 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.