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Last Updated: December 8, 2022

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 Pharms Ltd, Amneal Pharms, Apotex Inc, 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 Labs Pvt Ltd, Unichem, Watson Labs Inc, Yiling, Bdsi, and Kowa Pharms, and is included in twenty-six 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. 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
Sun Yat-sen UniversityPhase 2
Arthritis Innovation CorporationPhase 3
AllucentPhase 3

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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
Cipla CELECOXIB celecoxib CAPSULE;ORAL 207446-001 Sep 23, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jubilant Generics CELECOXIB celecoxib CAPSULE;ORAL 207061-003 Apr 4, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sciegen Pharms Inc CELECOXIB celecoxib CAPSULE;ORAL 205129-001 Dec 3, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acic Pharms CELECOXIB celecoxib CAPSULE;ORAL 212925-002 Dec 9, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs Inc CELECOXIB celecoxib CAPSULE;ORAL 200562-001 Feb 11, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Yiling CELECOXIB celecoxib CAPSULE;ORAL 211412-001 Mar 6, 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

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
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-001 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 020998-002 Dec 31, 1998 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
Russian Federation 2018146386 ПЕРОРАЛЬНАЯ КОМПОЗИЦИЯ ЦЕЛЕКОКСИБА ДЛЯ ЛЕЧЕНИЯ БОЛИ See Plans and Pricing
China 107847437 See Plans and Pricing
Australia 2019203815 See Plans and Pricing
Russian Federation 2017144574 See Plans and Pricing
Brazil 112017025445 See Plans and Pricing
China 114469858 用于治疗疼痛的塞来昔布口服组合物 (Oral composition of celecoxib for treating 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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