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Profile for Tradename: CELEBREX

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Celebrex is a drug marketed by Gd Searle and is included in one NDA. It is available from twenty-four suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CELEBREX is celecoxib. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the celecoxib profile page.

Summary for Tradename: CELEBREX

Patents:2
Applicants:1
NDAs:1
Suppliers: see list24
2013 Sales:$2,237,658,000

Pharmacology for Tradename: CELEBREX

Clinical Trials for: CELEBREX

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
Status: Completed Condition: Lung Cancer

The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Status: Completed Condition: Ovulation; Luteal Development

Celecoxib for Pediatric Adenotonsillectomy
Status: Completed Condition: Tonsillectomy; Adenotonsillectomy; Pain, Postoperative

Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA
Status: Recruiting Condition: Knee Osteoarthritis

Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Status: Completed Condition: Recurrent Respiratory Papillomatosis

Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B
Status: Recruiting Condition: Healthy

Celecoxib as a Chemopreventive Agent in Current and Former Smokers
Status: Completed Condition: Smoking; Prevention

The Impact of Genotype on Plasma and Cerebral Spinal Fluid Pharmacokinetics of Celecoxib in Children
Status: Not yet recruiting Condition: Pharmacokinetics of Celecoxib in Children

Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Status: Completed Condition: Breast Neoplasms; Breast Cancer

European Celecoxib Trial in Primary Breast Cancer
Status: Active, not recruiting Condition: Breast Cancer

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-004Dec 15, 2006RXNoRE44048*PED<disabled><disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-003Aug 29, 2002RXYesRE44048*PED<disabled><disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-001Dec 31, 1998RXNo5,760,068*PED<disabled>Y<disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-003Aug 29, 2002RXYes5,760,068*PED<disabled>Y<disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-004Dec 15, 2006RXNo5,760,068*PED<disabled>Y<disabled>
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Paragraph IV activity for: CELEBREX

Drugname Dosage Strength RLD Submissiondate
celecoxibCapsules50 mgCelebrex3/21/2008

Non-Orange Book Patents for Tradename: CELEBREX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,492,411 Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation<disabled in preview>
5,508,426 Substituted pyrazolyl benzenesulfonamide compounds for the treatment of inflammation<disabled in preview>
5,466,823 Substituted pyrazolyl benzenesulfonamides<disabled in preview>
6,413,960 Substituted pyrazolyl benzenesulfonamides for the treatment of asthma<disabled in preview>
5,521,207 Substituted pyrazolyl benzenesulfonamide for the treatment of inflammation<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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