PREDNICARBATE - Generic Drug Details

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What are the generic 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. One supplier is listed for this compound.

Summary for PREDNICARBATE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	1
Patent Applications:	7,001
Drug Prices:	Drug price trends for PREDNICARBATE
What excipients (inactive ingredients) are in PREDNICARBATE?	PREDNICARBATE excipients list
DailyMed Link:	PREDNICARBATE at DailyMed

See drug prices for PREDNICARBATE

Recent Clinical Trials for PREDNICARBATE

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

Sponsor	Phase
Handok Inc.	Phase 4
Handok Pharmaceuticals Co., Ltd.	Phase 4

See all PREDNICARBATE clinical trials

Pharmacology for PREDNICARBATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PREDNICARBATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for PREDNICARBATE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Bermuda	DERMATOP E EMOLLIENT	prednicarbate	CREAM;TOPICAL	020279-001	Oct 29, 1993		DISCN	Yes	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 PREDNICARBATE

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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	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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