You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

DOFETILIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Dofetilide, and when can generic versions of Dofetilide launch?

Dofetilide is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, and Teva Pharms Usa. and is included in twelve NDAs.

The generic ingredient in DOFETILIDE 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 Dofetilide

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

  Try a Trial

Drug patent expirations by year for DOFETILIDE
Drug Prices for DOFETILIDE

See drug prices for DOFETILIDE

Recent Clinical Trials for DOFETILIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thryv Therapeutics, Inc.Phase 1/Phase 2
Duke Clinical Research InstitutePhase 4
American Heart AssociationPhase 4

See all DOFETILIDE clinical trials

Pharmacology for DOFETILIDE
Drug ClassAntiarrhythmic
Paragraph IV (Patent) Challenges for DOFETILIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIKOSYN Capsules dofetilide 0.125 mg, 0.25 mg, and 0.5 mg 020931 1 2014-05-01

US Patents and Regulatory Information for DOFETILIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm DOFETILIDE dofetilide CAPSULE;ORAL 210466-002 Oct 9, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma DOFETILIDE dofetilide CAPSULE;ORAL 208519-001 Oct 9, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm DOFETILIDE dofetilide CAPSULE;ORAL 210466-003 Oct 9, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma DOFETILIDE dofetilide CAPSULE;ORAL 208519-002 Oct 9, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare DOFETILIDE dofetilide CAPSULE;ORAL 213338-001 Jun 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs DOFETILIDE dofetilide CAPSULE;ORAL 212410-003 Dec 27, 2019 DISCN 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 DOFETILIDE

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

Make Better Decisions: Try a trial or see plans & pricing

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.