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Last Updated: December 5, 2022

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, Encube, Fougera Pharms Inc, Glenmark Generics, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Fougera Pharms, Taro Pharm Inds Ltd, Alvogen, Bausch, 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 three 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-one 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

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SponsorPhase
Rochester Skin Lymphoma Medical Group, PLLCN/A
Rochester General HospitalN/A
Bausch Health Americas, 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 Strength NDA ANDAs Submitted Submissiondate
VANOS Cream fluocinonide 0.1% 021758 1 2008-01-31

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
Xiromed FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 212976-001 Nov 26, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novel Labs Inc FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 206003-001 Jul 21, 2017 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 072522-001 Sep 28, 1990 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pai Holdings Pharm FLUOCINONIDE fluocinonide CREAM;TOPICAL 211758-001 Apr 3, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Alvogen LIDEX fluocinonide CREAM;TOPICAL 016908-002 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 See Plans and Pricing See Plans and Pricing
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 See Plans and Pricing See Plans and Pricing
Alvogen LIDEX fluocinonide OINTMENT;TOPICAL 016909-002 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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