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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Colorcon
Fuji
US Army
Queensland Health
McKinsey
Medtronic
AstraZeneca
Federal Trade Commission
Covington

Generated: October 20, 2017

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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 is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dofetilide has fifty-five patent family members in forty-six countries and three supplementary protection certificates in three countries.

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

Summary for Generic Name: dofetilide

US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list11
Suppliers / Packagers: see list4
Bulk Api Vendors: see list61
Clinical Trials: see list8
Patent Applications: see list2,519
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;ORAL020931-001Oct 1, 1999ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-001Jun 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-002Jun 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-003Oct 1, 1999ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 1999ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-003Jun 6, 2016ABRXNoNo► Subscribe► 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, 1999► Subscribe► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-003Oct 1, 1999► Subscribe► Subscribe
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 1999► Subscribe► Subscribe
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International Patent Family for Ingredient: dofetilide

Country Document Number Estimated Expiration
Japan3569495► Subscribe
African Regional IP Organization (ARIPO)906► Subscribe
China1278246► Subscribe
Turkey200001135► Subscribe
Malaysia123352► Subscribe
African Intellectual Property Organization (OAPI)11350► Subscribe
Norway20002191► Subscribe
Ukraine67755► Subscribe
African Regional IP Organization (ARIPO)9801371► Subscribe
Saudi Arabia1168► 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
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Harvard Business School
Cantor Fitzgerald
Cipla
Colorcon
Medtronic
Moodys
Fuji
Teva

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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