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Last Updated: March 28, 2024

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.

Drug patent expirations by year for BEXTRA
Recent Clinical Trials for BEXTRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PfizerPhase 4
PfizerPhase 3

See all BEXTRA clinical trials

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
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Withdrawn no no no 2003-03-27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

Supplementary Protection Certificates for BEXTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809636 300128 Netherlands ⤷  Try a Trial
0809636 91024 Luxembourg ⤷  Try a Trial 91024, EXPIRES: 20180327
0809636 C300128 Netherlands ⤷  Try a Trial 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
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 SPC011/2003 Ireland ⤷  Try a Trial SPC011/2003: 20030604, EXPIRES: 20160212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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