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Last Updated: November 22, 2024

FLUOCINONIDE - Generic Drug Details


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What are the generic sources for fluocinonide and what is the scope of patent protection?

Fluocinonide is the generic ingredient in five branded drugs marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Fougera Pharms, Alvogen, Bausch, Padagis Us, Chartwell Rx, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for fluocinonide. Twenty-nine 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
University of CataniaN/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
Taro FLUOCINONIDE fluocinonide CREAM;TOPICAL 071500-001 Jun 10, 1987 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 208948-001 Jul 17, 2018 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fougera Pharms Inc FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 072934-001 Feb 27, 1995 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen LIDEX fluocinonide SOLUTION;TOPICAL 018849-001 Apr 6, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fougera Pharms FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 074905-001 Aug 26, 1997 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 207538-001 Jul 31, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 ⤷  Sign Up ⤷  Sign Up
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 ⤷  Sign Up ⤷  Sign Up
Alvogen LIDEX fluocinonide OINTMENT;TOPICAL 016909-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 ⤷  Sign Up ⤷  Sign Up
Bausch VANOS fluocinonide CREAM;TOPICAL 021758-001 Feb 11, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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