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Serving leading biopharmaceutical companies globally:

Moodys
Queensland Health
Colorcon
Merck
Citi
US Army
Johnson and Johnson
Fish and Richardson
Covington
Boehringer Ingelheim

Generated: January 16, 2018

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 Mayne Pharma Inc and Pfizer, 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-four 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.
Pharmacology for dofetilide
Drug ClassAntiarrhythmic

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
Mayne Pharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 207058-003 Jun 6, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mayne Pharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 207058-002 Jun 6, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mayne Pharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 207058-001 Jun 6, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for dofetilide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 ➤ Subscribe ➤ Subscribe
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 ➤ Subscribe ➤ Subscribe
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for dofetilide

Supplementary Protection Certificates for dofetilide

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

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Serving leading biopharmaceutical companies globally:

Julphar
Citi
McKesson
QuintilesIMS
McKinsey
UBS
US Army
Cipla
Queensland Health

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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