Rofecoxib - Generic Drug Details
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What are the generic sources for rofecoxib and what is the scope of freedom to operate?
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 |
| 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 |
| University of Pennsylvania | Phase 1 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for rofecoxib
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | DISCN | No | 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 rofecoxib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
