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Generated: December 13, 2017

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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 fluocinolone acetonide patent protection?

Fluocinolone acetonide
is the generic ingredient in thirteen branded drugs marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Galderma Labs Lp, Actavis Labs Ut Inc, G And W Labs Inc, Gavis Pharms Llc, and Morton Grove, and is included in sixty-five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and eighty-three patent family members in twenty-six countries and one supplementary protection certificate in one country.

There are twelve drug master file entries for fluocinolone acetonide. Twenty-three suppliers are listed for this compound.

Pharmacology for FLUOCINOLONE ACETONIDE

Medical Subject Heading (MeSH) Categories for FLUOCINOLONE ACETONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Allergan HerbertFLUONIDfluocinolone acetonideCREAM;TOPICAL087156-002Sep 6, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PharmadermFLUOCINOLONE ACETONIDEfluocinolone acetonideOINTMENT;TOPICAL088046-001Dec 16, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PharmafairFLUOCINOLONE ACETONIDEfluocinolone acetonideSOLUTION;TOPICAL088449-001Feb 8, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AkornFLUOCINOLONE ACETONIDEfluocinolone acetonideOIL;TOPICAL091514-001Jun 25, 2015ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo IsraelFLUOCINOLONE ACETONIDEfluocinolone acetonideOIL;TOPICAL202847-001Aug 9, 2013ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LyneFLUOCINOLONE ACETONIDEfluocinolone acetonideOIL;TOPICAL090982-001Apr 25, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alimera Sciences IncILUVIENfluocinolone acetonideIMPLANT;INTRAVITREAL201923-001Sep 26, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpCAPEXfluocinolone acetonideSHAMPOO;TOPICAL020001-001Aug 27, 1990RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo New YorkFLUOCINOLONE ACETONIDEfluocinolone acetonideCREAM;TOPICAL086810-001Mar 4, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alimera Sciences IncILUVIENfluocinolone acetonideIMPLANT;INTRAVITREAL201923-001Sep 26, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fluocinolone acetonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,439,249Inhibitors of phosphatases► Subscribe
9,566,336In situ gelling drug delivery system► Subscribe
8,815,284Bioerodible sustained release drug delivery systems► Subscribe
9,192,579Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof► Subscribe
8,574,659Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof► Subscribe
8,574,613Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fluocinolone acetonide

Country Document Number Estimated Expiration
Austria409023► Subscribe
World Intellectual Property Organization (WIPO)2005002625► Subscribe
Canada2484632► Subscribe
Spain2315680► Subscribe
Malaysia135804► Subscribe
China101396335► Subscribe
Australia2008261114► Subscribe
World Intellectual Property Organization (WIPO)2004066979► Subscribe
BrazilPI0406858► Subscribe
Brazil0110243► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FLUOCINOLONE ACETONIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000063Germany► SubscribePRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
Julphar
Fuji
Mallinckrodt
Fish and Richardson
Teva
Boehringer Ingelheim
Express Scripts
Cantor Fitzgerald

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 verifification 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.

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