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Last Updated: March 7, 2021

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Fluocinonide - Generic Drug Details

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What are the generic drug sources for fluocinonide and what is the scope of freedom to operate?

Fluocinonide is the generic ingredient in five branded drugs marketed by Amneal, Cadila, Cosette, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent, Teva, Fougera Pharms, Taro Pharm Inds Ltd, Cnty Line Pharms, Medicis, Novel Labs Inc, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Zydus Pharms, and is included in forty-six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluocinonide has eleven patent family members in nine countries.

There are nine drug master file entries for fluocinonide. Thirty-three suppliers are listed for this compound.

Drug Prices for fluocinonide

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Drug Sales Revenue Trends for fluocinonide

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Recent Clinical Trials for fluocinonide

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

SponsorPhase
Rochester General HospitalN/A
Rochester Skin Lymphoma Medical Group, PLLCN/A
Valeant Pharmaceuticals International, Inc.N/A

See all fluocinonide clinical trials

Pharmacology for fluocinonide
Medical Subject Heading (MeSH) Categories for fluocinonide
Paragraph IV (Patent) Challenges for FLUOCINONIDE
Tradename Dosage Ingredient NDA Submissiondate
VANOS CREAM;TOPICAL fluocinonide 021758 2008-01-31
LIDEX OINTMENT;TOPICAL fluocinonide 016909

US Patents and Regulatory Information for fluocinonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Taro FLUOCINONIDE fluocinonide CREAM;TOPICAL 071500-001 Jun 10, 1987 AB1 RX No No   Start Trial   Start Trial   Start Trial
Medicis VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Encube Ethicals FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 209699-001 Nov 29, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Teva FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 072511-001 Feb 7, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Cosette FLUOCINONIDE fluocinonide GEL;TOPICAL 072537-001 Feb 7, 1989 AB RX No No   Start Trial   Start Trial   Start Trial
Teligent FLUOCINONIDE fluocinonide CREAM;TOPICAL 211758-001 Apr 3, 2019 AB RX 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 fluocinonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Cnty Line Pharms LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Cnty Line Pharms LIDEX fluocinonide OINTMENT;TOPICAL 016909-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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