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Last Updated: March 19, 2024

Celecoxib - Generic Drug Details


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What are the generic drug sources for celecoxib and what is the scope of freedom to operate?

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, Mylan, Nanjing, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, Scilex Hldg, 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-two 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
Peking University Third HospitalN/A
Zhejiang UniversityPhase 2
Joseph KowalskiPhase 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
Teva CELECOXIB celecoxib CAPSULE;ORAL 076898-001 May 30, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Scilex Hldg ELYXYB celecoxib SOLUTION;ORAL 212157-001 May 5, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Scilex Hldg ELYXYB celecoxib SOLUTION;ORAL 212157-001 May 5, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kowa Pharms SEGLENTIS celecoxib; tramadol hydrochloride TABLET;ORAL 213426-001 Oct 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd CELECOXIB celecoxib CAPSULE;ORAL 202240-004 Jun 9, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yabao Pharm CELECOXIB celecoxib CAPSULE;ORAL 212564-001 Apr 10, 2023 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 celecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998 ⤷  Try a Trial ⤷  Try a Trial
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998 ⤷  Try a Trial ⤷  Try a Trial
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for celecoxib

Country Patent Number Title Estimated Expiration
Russian Federation 2745196 ПЕРОРАЛЬНАЯ КОМПОЗИЦИЯ ЦЕЛЕКОКСИБА ДЛЯ ЛЕЧЕНИЯ БОЛИ (ORAL CELECOXIB COMPOSITION FOR PAIN TREATMENT) ⤷  Try a Trial
Japan 6605047 ⤷  Try a Trial
Japan 2018516266 疼痛治療のためのセレコキシブの経口用組成物 ⤷  Try a Trial
Brazil 112018074486 composição oral de celecoxib para tratamento da dor ⤷  Try a Trial
European Patent Office 3302429 ⤷  Try a Trial
South Korea 101994129 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for celecoxib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0731795 10075033 Germany ⤷  Try a Trial 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.