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Last Updated: March 28, 2024

DOFETILDE Drug Patent Profile


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When do Dofetilde patents expire, and when can generic versions of Dofetilde launch?

Dofetilde is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.

The generic ingredient in DOFETILDE is dofetilide. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dofetilde

A generic version of DOFETILDE was approved as dofetilide by DR REDDYS LABS SA on June 6th, 2016.

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Summary for DOFETILDE
Drug patent expirations by year for DOFETILDE
Pharmacology for DOFETILDE
Drug ClassAntiarrhythmic

US Patents and Regulatory Information for DOFETILDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd DOFETILDE dofetilide CAPSULE;ORAL 210740-001 Jan 22, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd DOFETILDE dofetilide CAPSULE;ORAL 210740-002 Jan 22, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd DOFETILDE dofetilide CAPSULE;ORAL 210740-003 Jan 22, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for DOFETILDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Limited Tikosyn dofetilide EMEA/H/C/000238
Tikosyn is a Class III antiarrhythmic agent that is indicated for the following:Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1).Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate.Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation).
Withdrawn no no no 1999-11-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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