VALDECOXIB - Generic Drug Details
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What are the generic drug sources for valdecoxib and what is the scope of patent protection?
Valdecoxib
is the generic ingredient in one branded drug marketed by Gd Searle and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for VALDECOXIB
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 30 |
| Patent Applications: | 7,355 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | VALDECOXIB at DailyMed |
Recent Clinical Trials for VALDECOXIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Sao Paulo | Phase 4 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
| University of Pennsylvania | Phase 1 |
US Patents and Regulatory Information for VALDECOXIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-002 | Nov 16, 2001 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | 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 VALDECOXIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-002 | Nov 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-002 | Nov 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VALDECOXIB
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacia - Pfizer EEIG | Bextra | valdecoxib | EMEA/H/C/000431 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk (see sections 4.3, 4.4). |
Withdrawn | no | no | no | 2003-03-27 | |
| Pfizer Limited | Valdyn (previously Kudeq) | valdecoxib | EMEA/H/C/000437 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea. |
Withdrawn | no | no | no | 2003-03-27 | |
| Pharmacia Europe EEIG | Valdyn | valdecoxib | EMEA/H/C/000432 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea. |
Withdrawn | no | no | no | 2003-03-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
