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Last Updated: May 21, 2022

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, 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 Morton Grove, and is included in seventy-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eleven drug master file entries for fluocinolone acetonide. Nineteen 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
EyePoint Pharmaceuticals, Inc.Phase 4
CBCC Global ResearchPhase 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
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
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan Herbert FLUONID fluocinolone acetonide GEL;TOPICAL 087300-001 May 27, 1982 DISCN No No See Plans and Pricing See Plans and Pricing 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
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 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

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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