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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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Federal Trade Commission
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Generated: July 22, 2017

DrugPatentWatch Database Preview

Dofetilide - Generic Drug Details

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

Dofetilide
is the generic ingredient in two branded drugs marketed by Pfizer and Mayne Pharma Inc, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dofetilide has fifty-two patent family members in forty-six countries.

There are eight drug master file entries for dofetilide. Four suppliers are listed for this compound.

Summary for Generic Name: dofetilide

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list61
Clinical Trials: see list7
Patent Applications: see list2,446
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dofetilide at DailyMed

Pharmacology for Ingredient: dofetilide

Drug ClassAntiarrhythmic
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;ORAL020931-003Oct 1, 1999ABRXYesYes6,124,363► Subscribe ► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 1999ABRXYesNo6,124,363► Subscribe ► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-001Jun 6, 2016ABRXNoNo► Subscribe► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-003Jun 6, 2016ABRXNoNo► Subscribe► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-001Oct 1, 1999ABRXYesNo6,124,363► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dofetilide

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

Country Document Number Estimated Expiration
Norway325630► Subscribe
Austria232199► Subscribe
Bulgaria104373► Subscribe
Yugoslavia24000► Subscribe
United Kingdom9722662► Subscribe
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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
00002Netherlands► SubscribePRODUCT 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
00C/005Belgium► SubscribePRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
C/GB00/005United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Harvard Business School
Dow
Express Scripts
Cipla
Mallinckrodt
Julphar
Argus Health
Baxter

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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