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Last Updated: June 28, 2022

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 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, and Yiling. and is included in twenty-three NDAs.

The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Fifty-four 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 MYLAN 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
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 210628-003 Nov 27, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Micro Labs CELECOXIB celecoxib CAPSULE;ORAL 204776-001 Apr 30, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jubilant Generics CELECOXIB celecoxib CAPSULE;ORAL 207061-004 Apr 4, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nanjing CELECOXIB celecoxib CAPSULE;ORAL 213598-001 May 13, 2020 AB RX No No See Plans and Pricing See Plans and Pricing 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

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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Serving leading biopharmaceutical companies globally:

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Express Scripts
Medtronic

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