BEXTRA Drug Patent Profile
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When do Bextra patents expire, and when can generic versions of Bextra launch?
Bextra is a drug marketed by Gd Searle and is included in one NDA.
The generic ingredient in BEXTRA is valdecoxib. Additional details are available on the valdecoxib profile page.
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Summary for BEXTRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,408 |
| DailyMed Link: | BEXTRA at DailyMed |
Recent Clinical Trials for BEXTRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
| Pfizer | Phase 3 |
US Patents and Regulatory Information for BEXTRA
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | 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 BEXTRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-002 | Nov 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | Nov 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-002 | Nov 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BEXTRA
| 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 |
International Patents for BEXTRA
See the table below for patents covering BEXTRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 920422 | ⤷ Sign Up | |
| Australia | 722072 | ⤷ Sign Up | |
| Israel | 161224 | ⤷ Sign Up | |
| Bulgaria | 103155 | ⤷ Sign Up | |
| Denmark | 0809636 | ⤷ Sign Up | |
| Canada | 2264104 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BEXTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0809636 | 91024 | Luxembourg | ⤷ Sign Up | 91024, EXPIRES: 20180327 |
| 0809636 | 300128 | Netherlands | ⤷ Sign Up | |
| 0809636 | SPC011/2003 | Ireland | ⤷ Sign Up | SPC011/2003: 20030604, EXPIRES: 20160212 |
| 0809636 | SPC/GB03/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: VALDECOXIB OR ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/244/001-024 20030327; UK EU/1/02/239/001-024 20030327; UK EU/1/02/242/001-024 20030327 |
| 0809636 | C300128 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VALDECOXIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH ACCEPTABEL ZOUT; REGISTRATION NO/DATE: EU/1/02/239/001 - EU/1/02/239/024, EU/1/02/242/001 - EU/1/02/242/024, EU/1/02/244/001 - EU/1/02/244/024 20030317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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