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Last Updated: June 29, 2022

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 Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, 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 Labs Pvt Ltd, Unichem, Watson Labs Inc, Yiling, Bdsi, and Kowa Pharms, and is included in twenty-six NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-six drug master file entries for celecoxib. Fifty-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
Third Affiliated Hospital, Sun Yat-Sen UniversityPhase 2
Tanta UniversityPhase 3
Lai WeiPhase 2

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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 Labs Pvt Ltd CELECOXIB celecoxib CAPSULE;ORAL 210628-001 Nov 27, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd CELECOXIB celecoxib CAPSULE;ORAL 206827-003 Feb 1, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kowa Pharms SEGLENTIS celecoxib; tramadol hydrochloride TABLET;ORAL 213426-001 Oct 15, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 020998-002 Dec 31, 1998 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006 See Plans and Pricing See Plans and Pricing
>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
Australia 2017275844 Oral composition of celecoxib for treatment of pain See Plans and Pricing
Brazil 112018074486 composição oral de celecoxib para tratamento da dor See Plans and Pricing
European Patent Office 3463340 COMPOSITION DE CÉLÉCOXIB À USAGE ORAL POUR LE TRAITEMENT DE LA DOULEUR (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN) See Plans and Pricing
>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 See Plans and Pricing 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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