Rofecoxib - Generic Drug Details
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What are the generic sources for rofecoxib and what is the scope of patent protection?
Rofecoxib
is the generic ingredient in one branded drug marketed by Merck and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for rofecoxib.
Summary for rofecoxib
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 40 |
Patent Applications: | 7,190 |
Formulation / Manufacturing: | see details |
DailyMed Link: | rofecoxib at DailyMed |
Recent Clinical Trials for rofecoxib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tremeau Pharmceuticals, Inc. | Phase 3 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
University of Pennsylvania | Phase 1 |
US Patents and Regulatory Information for rofecoxib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 rofecoxib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |