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Details for Generic Name: dofetilide

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Dofetilide is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty patent family members in forty-five countries.

There is one drug master file entry for dofetilide. One supplier is listed for this compound.

Summary for Generic Name: dofetilide

Drug Master File Entries: see list1
Suppliers / Packaging: see list9
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: dofetilide

Drug ClassAntiarrhythmic

Clinical Trials for: dofetilide

Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
Status: Completed Condition: Long QT Syndrome

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
Status: Completed Condition: Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics

PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide
Status: Not yet recruiting Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
Status: Completed Condition: Drug-induced Surface ECG Changes

Genetics of QT Prolongation With Antiarrhythmics
Status: Recruiting Condition: Long QT Syndrome; Drug Toxicity

Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Status: Completed Condition: Cardiac Arrhythmia; Qt Interval, Variation in

High Intensity Focused Ultrasound (HIFU) Ablation System Study
Status: Suspended Condition: Atrial Fibrillation

AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Status: Terminated Condition: Atrial Fibrillation; Heart Failure

Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Status: Withdrawn Condition: Atrial Fibrillation

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
Status: Completed 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
CAPSULE;ORAL020931-001Oct 1, 1999RXNo6,124,363<disabled> <disabled>
CAPSULE;ORAL020931-003Oct 1, 1999RXYes6,124,363<disabled> <disabled>
CAPSULE;ORAL020931-002Oct 1, 1999RXNo6,124,363<disabled> <disabled>
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International Patent Family for Ingredient: dofetilide

Country Document Number Publication Date
Iceland2179Dec 15, 2006
World Intellectual Property Organization (WIPO)9921829May 06, 1999
China1278246Dec 27, 2000
United Kingdom9722662Dec 24, 1997
Norway20002191Apr 27, 2000
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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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