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Cantor Fitzgerald
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Generated: August 23, 2017

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Fluocinolone acetonide - Generic Drug Details

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What are the generic drug 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 Allergan Herbert, Galderma Labs Lp, Taro, Akorn, Pharmafair, Identi Pharms Inc, Perrigo New York, Morton Grove, Gavis Pharms Llc, Alimera Sciences Inc, G And W Labs, Bausch And Lomb, G And W Labs Inc, Usl Pharma, Pharmaderm, Perrigo Israel, Hill Dermac, Alpharma Us Pharms, Medimetriks Pharms, Fougera Pharms Inc, Savage Labs, Lyne, and Actavis Labs Ut Inc, and is included in sixty-four 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 sixty-five patent family members in twenty-six countries.

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

Summary for Generic Name: fluocinolone acetonide

Tradenames:13
Patents:9
Applicants:23
NDAs:64
Drug Master File Entries: see list12
Suppliers / Packagers: see list22
Bulk Api Vendors: see list42
Clinical Trials: see list150
Patent Applications: see list4,655
Therapeutic Class:Otic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluocinolone acetonide at DailyMed

Pharmacology for Ingredient: fluocinolone acetonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lyne
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
OIL;TOPICAL203377-001Apr 25, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
TRI-LUMA
fluocinolone acetonide; hydroquinone; tretinoin
CREAM;TOPICAL021112-001Jan 18, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Alpharma Us Pharms
FLUOCET
fluocinolone acetonide
CREAM;TOPICAL088360-001Jan 16, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Alpharma Us Pharms
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
SOLUTION;TOPICAL087159-001Jun 16, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Savage Labs
FLUOTREX
fluocinolone acetonide
SOLUTION;TOPICAL088171-001Mar 9, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Pharmaderm
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
CREAM;TOPICAL088045-001Dec 16, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lyne
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
OIL;TOPICAL090982-001Apr 25, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe
Medimetriks Pharms
SYNALAR
fluocinolone acetonide
CREAM;TOPICAL012787-002Approved Prior to Jan 1, 1982ATRXYesYes► Subscribe► Subscribe► Subscribe
Actavis Labs Ut Inc
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
SOLUTION;TOPICAL208386-001Oct 21, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe
Usl Pharma
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
CREAM;TOPICAL088756-001Mar 28, 1985DISCNNoNo► Subscribe► Subscribe► 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
9,192,579Sustained 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
8,815,284Bioerodible sustained release drug delivery systems► Subscribe
9,566,336In situ gelling drug delivery system► 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
Canada2530136► Subscribe
Portugal1635875► Subscribe
China1658836► Subscribe
Spain2338420► Subscribe
BrazilPI0406880► Subscribe
BrazilPI0406879► Subscribe
South Africa200604777► Subscribe
European Patent Office2233112► Subscribe
Australia2004207506► Subscribe
New Zealand581461► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Express Scripts
Covington
Julphar
Fish and Richardson
Healthtrust
Merck
Cerilliant
Fuji
Mallinckrodt

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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