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Last Updated: September 25, 2022

TIKOSYN Drug Patent Profile


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

Tikosyn is a drug marketed by Pfizer and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Tikosyn

A generic version of TIKOSYN was approved as dofetilide by MAYNE PHARMA INC on June 6th, 2016.

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Drug patent expirations by year for TIKOSYN
Drug Prices for TIKOSYN

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Recent Clinical Trials for TIKOSYN

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SponsorPhase
Food and Drug Administration (FDA)Phase 1
Spaulding Clinical Research LLCPhase 1
VA Office of Research and Development

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Pharmacology for TIKOSYN
Drug ClassAntiarrhythmic
Paragraph IV (Patent) Challenges for TIKOSYN
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 TIKOSYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 TIKOSYN

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

EU/EMA Drug Approvals for TIKOSYN

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

Supplementary Protection Certificates for TIKOSYN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0245997 2000C/005 Belgium See Plans and Pricing PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
0245997 SPC/GB00/005 United Kingdom See Plans and Pricing PRODUCT NAME: DOFETILIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/99/121/001 19991129; UK EU/1/99/121/002 19991129; UK EU/1/99/121/003 19991129; UK EU/1/99/121/004 19991129; UK EU/1/99/121/005 19991129; UK EU/1/99/121/006 19991129; UK EU/1/99/121/007 19991129; UK EU/1/99/121/008 19991129; UK EU/1/99/121/009 19991129; UK EU/1/99/121/010 19991129; UK EU/1/99/121/011 19991129; UK EU/1/99/121/012 19991129; UK EU/1/99/121/013 19991129; UK EU/1/99/121/014 19991129; UK EU/1/99/121/015 19991129
0245997 C300002 Netherlands See Plans and Pricing PRODUCT NAME: DOFETILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/99/121/001 - EU/1/99/121/015 19991129
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Baxter

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