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Last Updated: October 25, 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 freedom to operate?

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, Amneal, 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

See drug prices for fluocinolone acetonide

Recent Clinical Trials for fluocinolone acetonide

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

SponsorPhase
Pradeepa YoganathanPhase 2
St. Michael's Hospital, TorontoPhase 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
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Herbert FLUONID fluocinolone acetonide CREAM;TOPICAL 087156-002 Sep 6, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Glasshouse Pharms FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 209596-001 Dec 26, 2017 AT RX No No   Start Trial   Start Trial   Start Trial
Eyepoint Pharms YUTIQ fluocinolone acetonide IMPLANT;INTRAVITREAL 210331-001 Oct 12, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cosette FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 207441-001 Sep 28, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmaderm FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 088046-001 Dec 16, 1982 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
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014   Start Trial   Start Trial
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005   Start Trial   Start Trial
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
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
>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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