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Last Updated: March 29, 2024

CELECOXIB Drug Patent Profile


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When do Celecoxib patents expire, and when can generic versions of Celecoxib launch?

Celecoxib is a drug marketed by Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Nanjing, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, and Yiling. and is included in twenty-four NDAs.

The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Celecoxib

A generic version of CELECOXIB was approved as celecoxib by TEVA on May 30th, 2014.

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Drug patent expirations by year for CELECOXIB
Drug Prices for CELECOXIB

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Drug Sales Revenue Trends for CELECOXIB

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Recent Clinical Trials for CELECOXIB

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SponsorPhase
Peking University Third HospitalN/A
Zhejiang UniversityPhase 2
University of IowaPhase 4

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Pharmacology for CELECOXIB
Medical Subject Heading (MeSH) Categories for CELECOXIB
Paragraph IV (Patent) Challenges for CELECOXIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CELEBREX Capsules celecoxib 50 mg 020998 1 2008-03-21

US Patents and Regulatory Information for CELECOXIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Umedica CELECOXIB celecoxib CAPSULE;ORAL 210628-003 Nov 27, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs CELECOXIB celecoxib CAPSULE;ORAL 204776-001 Apr 30, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics CELECOXIB celecoxib CAPSULE;ORAL 207061-004 Apr 4, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yiling CELECOXIB celecoxib CAPSULE;ORAL 211412-002 Mar 6, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nanjing CELECOXIB celecoxib CAPSULE;ORAL 213598-001 May 13, 2020 AB RX 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

EU/EMA Drug Approvals for CELECOXIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Limited Onsenal celecoxib EMEA/H/C/000466
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Withdrawn no no no 2003-10-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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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.