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Last Updated: September 19, 2020

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DOFETILIDE Drug Profile

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

Dofetilide is a drug marketed by Accord Hlthcare, Bionpharma Inc, Mayne Pharma Inc, MSN, Par Pharm Inc, Prinston Inc, Riconpharma Llc, Sigmapharm Labs Llc, and Sun Pharm. and is included in nine NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Dofetilide

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

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Drug patent expirations by year for DOFETILIDE
Drug Prices for DOFETILIDE

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Recent Clinical Trials for DOFETILIDE

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SponsorPhase
Oregon Health and Science UniversityPhase 2
Gilead SciencesPhase 1
Brigham and Women's HospitalN/A

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Pharmacology for DOFETILIDE
Drug ClassAntiarrhythmic
Paragraph IV (Patent) Challenges for DOFETILIDE
Tradename Dosage Ingredient NDA Submissiondate
TIKOSYN CAPSULE;ORAL dofetilide 020931 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
Accord Hlthcare DOFETILIDE dofetilide CAPSULE;ORAL 213338-001 Jun 19, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc DOFETILIDE dofetilide CAPSULE;ORAL 211223-003 Dec 17, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc DOFETILIDE dofetilide CAPSULE;ORAL 207746-003 Mar 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 207058-001 Jun 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 208625-001 Apr 10, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Msn DOFETILIDE dofetilide CAPSULE;ORAL 213220-003 Jan 29, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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