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.
Summary for BEXTRA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 3 |
Patent Applications: | 4,498 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for BEXTRA
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 | ⤷ 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 BEXTRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
Gd Searle | BEXTRA | valdecoxib | TABLET;ORAL | 021341-003 | 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 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 |
---|---|---|---|
Japan | 2005015497 | CRYSTAL FORM OF 4-[5-METHYL-3-PHENYLISOXAZOL-4-YL]BENZENESULFONAMIDE | ⤷ Try a Trial |
Romania | 120771 | FORMĂ CRISTALINĂ B A 4-(5-METIL-3-FENILIZOXAZOL-4-IL) BENZENSULFONAMIDEI (CRYSTALLINE FORM B OF 4-(5-METHYL-3-PHENYLISOXAZOL-4-YL)BENZENESULPHONAMIDE) | ⤷ Try a Trial |
Hong Kong | 1058004 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BEXTRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0809636 | SPC011/2003 | Ireland | ⤷ Try a Trial | SPC011/2003: 20030604, EXPIRES: 20160212 |
0809636 | SPC/GB03/022 | United Kingdom | ⤷ Try a Trial | 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 | 91024 | Luxembourg | ⤷ Try a Trial | 91024, EXPIRES: 20180327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |