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Last Updated: November 21, 2024

Celecoxib - Generic Drug Details


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What are the generic sources for celecoxib and what is the scope of patent protection?

Celecoxib is the generic ingredient in four branded drugs marketed by Upjohn, Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Norvium Bioscience, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, Scilex Pharms, and Kowa Pharms, and is included in twenty-seven NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Celecoxib has twenty-five patent family members in twelve countries.

There are twenty-six drug master file entries for celecoxib. Sixty-four suppliers are listed for this compound.

Drug Prices for celecoxib

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Drug Sales Revenue Trends for celecoxib

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Recent Clinical Trials for celecoxib

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

SponsorPhase
Xintian PharmaceuticalPhase 4
Translational Genomics Research InstitutePhase 1
HonorHealth Research InstitutePhase 1

See all celecoxib clinical trials

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
Alembic CELECOXIB celecoxib CAPSULE;ORAL 204519-004 Aug 21, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Umedica CELECOXIB celecoxib CAPSULE;ORAL 210628-003 Nov 27, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd CELECOXIB celecoxib CAPSULE;ORAL 204590-003 Mar 16, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Yiling CELECOXIB celecoxib CAPSULE;ORAL 211412-002 Mar 6, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd CELECOXIB celecoxib CAPSULE;ORAL 204590-002 Mar 16, 2016 AB RX 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 celecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 ⤷  Sign Up ⤷  Sign Up
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-002 Dec 31, 1998 ⤷  Sign Up ⤷  Sign Up
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-002 Dec 31, 1998 ⤷  Sign Up ⤷  Sign Up
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006 ⤷  Sign Up ⤷  Sign Up
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

Supplementary Protection Certificates for celecoxib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0731795 10075033 Germany ⤷  Sign Up PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
>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.