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. 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 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for prednicarbate |
What excipients (inactive ingredients) are in prednicarbate? | prednicarbate excipients list |
DailyMed Link: | prednicarbate at DailyMed |
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 |
Pharmacology for prednicarbate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ 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 | ||||
Fougera Pharms | PREDNICARBATE | prednicarbate | OINTMENT;TOPICAL | 077236-001 | Mar 9, 2007 | RX | No | Yes | ⤷ 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
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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