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Last Updated: June 23, 2024

Dofetilide - Generic Drug Details


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What are the generic drug sources for dofetilide and what is the scope of freedom to operate?

Dofetilide is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, Teva Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for dofetilide. Fifteen suppliers are listed for this compound.

Drug Prices for dofetilide

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Recent Clinical Trials for dofetilide

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SponsorPhase
Thryv Therapeutics, Inc.Phase 1/Phase 2
American Heart AssociationPhase 4
SanofiPhase 4

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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
Bionpharma DOFETILIDE dofetilide CAPSULE;ORAL 208625-001 Apr 10, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa DOFETILIDE dofetilide CAPSULE;ORAL 207058-002 Jun 6, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sigmapharm Labs Llc DOFETILIDE dofetilide CAPSULE;ORAL 207746-001 Mar 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs DOFETILIDE dofetilide CAPSULE;ORAL 212410-001 Dec 27, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn DOFETILIDE dofetilide CAPSULE;ORAL 213220-001 Jan 29, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules DOFETILIDE dofetilide CAPSULE;ORAL 212750-001 Oct 14, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc DOFETILIDE dofetilide CAPSULE;ORAL 211223-001 Dec 17, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dofetilide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

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