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Fluocinolone acetonide - Generic Drug Details

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Fluocinolone acetonide is the generic ingredient in thirteen branded drugs marketed by Allergan Herbert, Galderma Labs Lp, Taro, Versapharm Inc, 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, 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.

This ingredient has one hundred and fifty-five patent family members in twenty-six countries.

There are twelve drug master file entries for fluocinolone acetonide. Twenty-one 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 / Packaging: see list21
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fluocinolone acetonide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alimera Sciences Inc
ILUVIEN
fluocinolone acetonide
IMPLANT;INTRAVITREAL201923-001Sep 26, 2014RXYes6,217,895► subscribeY ► subscribe
Medimetriks Pharms
SYNALAR-HP
fluocinolone acetonide
CREAM;TOPICAL016161-002Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
Taro
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
SOLUTION;TOPICAL089124-001Sep 11, 1985RXNo► 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
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
7,439,249Inhibitors of phosphatases► 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
TaiwanI377958► subscribe
Australia2003287666► subscribe
Argentina028372► 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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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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