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Last Updated: June 13, 2021

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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 three branded drugs marketed by Gd Searle, 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, and Dr Reddys, and is included in twenty-five NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-six drug master file entries for celecoxib. Fifty-one 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
Imperial College LondonPhase 4
The University of Texas Health Science Center, HoustonPhase 4
New York State Psychiatric InstitutePhase 2

See all CELECOXIB clinical trials

Pharmacology for CELECOXIB
Medical Subject Heading (MeSH) Categories for CELECOXIB
Paragraph IV (Patent) Challenges for CELECOXIB
Tradename Dosage Ingredient NDA Submissiondate
CELEBREX CAPSULE;ORAL celecoxib 020998 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
Lupin Ltd CELECOXIB celecoxib CAPSULE;ORAL 202240-004 Jun 9, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Acic Pharms CELECOXIB celecoxib CAPSULE;ORAL 212925-002 Dec 9, 2020 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Unichem CELECOXIB celecoxib CAPSULE;ORAL 213301-002 Jan 12, 2021 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Dr Reddys ELYXYB celecoxib SOLUTION;ORAL 212157-001 May 5, 2020 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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
Gd Searle CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998   Get Started Free   Get Started Free
Gd Searle CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002   Get Started Free   Get Started Free
Gd Searle CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998   Get Started Free   Get Started Free
Gd Searle CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CELECOXIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0731795 10075033 Germany   Get Started Free 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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