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Last Updated: August 9, 2020

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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, Cosette, Fougera Pharms Inc, Invatech, 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, Identi Pharms Inc, Lyne, Perrigo Israel, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in seventy-three NDAs. There are ten 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 twelve drug master file entries for fluocinolone acetonide. Twenty suppliers are listed for this compound.

Drug Prices for FLUOCINOLONE ACETONIDE

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Recent Clinical Trials for FLUOCINOLONE ACETONIDE

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

SponsorPhase
St. Michael's Hospital, TorontoPhase 2
Pradeepa YoganathanPhase 2
Alimera SciencesPhase 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
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alpharma Us Pharms FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 088361-001 Jan 16, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Cosette FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 089525-001 Jul 26, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Savage Labs FLUOTREX fluocinolone acetonide CREAM;TOPICAL 088174-001 May 6, 1983 DISCN No No   Start Trial   Start Trial   Start 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
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018   Start Trial   Start Trial
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018   Start Trial   Start Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014   Start Trial   Start Trial
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018   Start Trial   Start Trial
>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 132014902285293 Italy   Start Trial PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
2233112 122014000063 Germany   Start 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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