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Details for Generic Name: celecoxib

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Celecoxib is the generic ingredient in two branded drugs marketed by Gd Searle, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Teva, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for celecoxib. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: celecoxib

Tradenames:2
Patents:2
Applicants:6
NDAs:6
Drug Master File Entries: see list22
Suppliers / Packaging: see list211
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: celecoxib

Tentative approvals for CELECOXIB

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE;ORAL50MG
<disabled><disabled>CAPSULE;ORAL100MG
<disabled><disabled>CAPSULE;ORAL200MG

Clinical Trials for: celecoxib

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

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

Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
Status: Completed Condition: Postoperative Pain Management; Total Knee Arthroplasty

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

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

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, 2006RXNo5,760,068*PED<disabled>Y<disabled>
Lupin Ltd
CELECOXIB
celecoxib
CAPSULE;ORAL202240-001Oct 29, 2014RXNo<disabled><disabled>
Lupin Ltd
CELECOXIB
celecoxib
CAPSULE;ORAL202240-004Jun 9, 2015RXNo<disabled><disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-003Aug 29, 2002RXYes5,760,068*PED<disabled>Y<disabled>
Teva
CELECOXIB
celecoxib
CAPSULE;ORAL076898-002May 30, 2014RXNo<disabled><disabled>
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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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