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Last Updated: August 11, 2020

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Prednicarbate - Generic Drug Details

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

Prednicarbate is the generic ingredient in three branded drugs marketed by Valeant Bermuda, Fougera Pharms, and Valeant Pharms North, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for prednicarbate. Two suppliers are listed for this compound.

Drug Prices for prednicarbate

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Recent Clinical Trials for prednicarbate

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SponsorPhase
Handok Pharmaceuticals Co., Ltd.Phase 4

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Pharmacology for prednicarbate

US Patents and Regulatory Information for prednicarbate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms PREDNICARBATE prednicarbate CREAM;TOPICAL 077287-001 Sep 19, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Fougera Pharms PREDNICARBATE prednicarbate OINTMENT;TOPICAL 077236-001 Mar 9, 2007 RX No Yes   Start Trial   Start Trial   Start Trial
Valeant Pharms North DERMATOP prednicarbate OINTMENT;TOPICAL 019568-001 Sep 23, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Bermuda DERMATOP E EMOLLIENT prednicarbate CREAM;TOPICAL 020279-001 Oct 29, 1993 DISCN Yes 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 prednicarbate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda DERMATOP E EMOLLIENT prednicarbate CREAM;TOPICAL 020279-001 Oct 29, 1993   Start Trial   Start Trial
Valeant Pharms North DERMATOP prednicarbate OINTMENT;TOPICAL 019568-001 Sep 23, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Colorcon

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