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Dofetilide - Generic Drug Details

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Dofetilide is the generic ingredient in two branded drugs marketed by Pfizer and Tiger Pharms Llc, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty patent family members in forty-five countries.

There are three drug master file entries for dofetilide. Three suppliers are listed for this compound.

Summary for Generic Name: dofetilide

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packaging: see list3
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: dofetilide

Drug ClassAntiarrhythmic

Clinical Trials for: dofetilide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tiger Pharms Llc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-002Jun 6, 2016RXNoDec 4, 2016
Tiger Pharms Llc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-001Jun 6, 2016RXNoDec 4, 2016
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 1999RXNo6,124,363Oct 9, 2018
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Expired Orange Book Patents for Generic Ingredient: dofetilide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-001Oct 1, 19994,959,366<disabled>
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-003Oct 1, 19994,959,366<disabled>
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 19994,959,366<disabled>
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International Patent Family for Ingredient: dofetilide

Country Document Number Estimated Expiration
Bulgaria104373<disabled in preview>
Denmark1027329<disabled in preview>
Indonesia24658<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DOFETILIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/005Belgium<disabled>PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
C/GB00/005United Kingdom<disabled>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
00002Netherlands<disabled>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
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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 verifification 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.

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