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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 forty-nine patent family members in forty-four 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: see list1
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: Recruiting 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: Active, not recruiting Condition: Drug-induced Surface ECG Changes

Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Status: Recruiting 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Status: Withdrawn Condition: Atrial Fibrillation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

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
Status: Completed Condition: Paroxysmal 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;ORAL020931-002Oct 1, 1999RXNo6,124,363<disabled><disabled>
CAPSULE;ORAL020931-001Oct 1, 1999RXNo6,124,363<disabled><disabled>
CAPSULE;ORAL020931-003Oct 1, 1999RXYes6,124,363<disabled><disabled>
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International Patent Family for Ingredient: dofetilide

Country Document Number Publication Date
Ukraine67755Sep 15, 2000
Algeria2632Mar 08, 2003
Uruguay25222Dec 29, 2000
Norway325630Jun 30, 2008
World Intellectual Property Organization (WIPO)9921829May 06, 1999
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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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