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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, Beecham, Impax Labs, Ivax Sub Teva Pharms, 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 is one tentative approval for this compound.

Summary for Generic Name: colchicine

Tradenames:7
Patents:18
Applicants:10
NDAs:12
Drug Master File Entries: see list14
Suppliers / Packaging: see list25
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: colchicine

Tentative approvals for COLCHICINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL0.6MG

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 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
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes8,415,395<disabled><disabled>
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes<disabled><disabled>
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes7,820,681<disabled><disabled>
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes7,981,938<disabled><disabled>
Watson Labs
PROBEN-C
colchicine; probenecid
TABLET;ORAL085552-001Approved Prior to Jan 1, 1982DISCNNo<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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