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Details for Generic Name: colchicine

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Colchicine is the generic ingredient in seven branded drugs marketed by Hikma Intl Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms Inc, Beecham, Impax Labs, Mirror Pharms, Sandoz, and Lederle, and is included in twelve NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for colchicine. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: colchicine

Drug Master File Entries: see list14
Suppliers / Packaging: see list25
Therapeutic Class:Antigout Agents

Pharmacology for Ingredient: colchicine

Tentative approvals for COLCHICINE

Applicant Application No. Form Dosage

Clinical Trials for: colchicine

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Status: Completed Condition: Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein

Drug-Drug Interaction Study of Colchicine and Azithromycin
Status: Completed Condition: Pharmacokinetics

Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Status: Completed Condition: Pharmacokinetics; Healthy

Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
Status: Recruiting Condition: Pericardial Effusion

Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients
Status: Completed Condition: Renal Replacement Therapies

Colchicine and CRP in Atrial Fibrillation and AF Ablation
Status: Recruiting Condition: Atrial Fibrillation

Courtesy of
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
Takeda Pharms Usa
TABLET;ORAL022352-001Jul 29, 2009RXYes8,093,298<disabled> <disabled>
Takeda Pharms Usa
TABLET;ORAL022352-001Jul 29, 2009RXYes<disabled><disabled>
Takeda Pharms Usa
TABLET;ORAL022352-001Jul 29, 2009RXYes8,093,297<disabled> <disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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