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.Summary for PREDNICARBATE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 1 |
| Patent Applications: | 7,814 |
| 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 Pharmaceuticals Co., Ltd. | Phase 4 |
| Handok Inc. | Phase 4 |
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 | ⤷ 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 | 4,242,334 | ⤷ Start Trial |
| Valeant Pharms North | DERMATOP | prednicarbate | OINTMENT;TOPICAL | 019568-001 | Sep 23, 1991 | 4,242,334 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
