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Last Updated: March 19, 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, Akorn, Amneal, Lyne, Padagis Israel, Quagen, 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-five 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
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 040041-001 Sep 15, 1994 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd FLUOCINONIDE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 211815-001 Dec 14, 2018 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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
Alimera Sciences Inc YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 ⤷  Try a Trial ⤷  Try a Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FLUOCINOLONE ACETONIDE

Country Patent Number Title Estimated Expiration
China 106176665 可持续释放药物的输送装置及其使用方法和制造方法 (Sustained release drug delivery device, method of use, and method of manufacturing thereof) ⤷  Try a Trial
European Patent Office 1503731 PROCEDES DE FABRICATION D'UN DISTRIBUTEUR DE MEDICAMENTS (PROCESSES FOR FORMING A DRUG DELIVERY DEVICE) ⤷  Try a Trial
European Patent Office 1592408 DISPOSITIF ET PROCEDE A LIBERATION PROLONGEE POUR L'ADMINISTRATION OCULAIRE D'AGENTS ADRENERGIQUES (SUSTAINED RELEASE DEVICE AND METHOD FOR OCULAR DELIVERY OF ADRENERGIC AGENTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLUOCINOLONE ACETONIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2233112 132014902285293 Italy ⤷  Try a Trial PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
2233112 122014000063 Germany ⤷  Try a 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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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.