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TIKOSYN Drug Profile

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Tikosyn is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

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

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

Summary for Tradename: TIKOSYN

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: TIKOSYN

Drug ClassAntiarrhythmic

Clinical Trials for: TIKOSYN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-001Oct 1, 1999RXNo6,124,363<disabled> <disabled>
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-002Oct 1, 1999RXNo6,124,363<disabled> <disabled>
Pfizer
TIKOSYN
dofetilide
CAPSULE;ORAL020931-003Oct 1, 1999RXYes6,124,363<disabled> <disabled>
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Expired Patents for Tradename: TIKOSYN

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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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Paragraph IV activity for: TIKOSYN

Drugname Dosage Strength RLD Submissiondate
dofetilideCapsules0.125 mg, 0.25 mg, and 0.5 mgTikosyn5/1/2014

International Patent Family for Tradename: TIKOSYN

Country Document Number Estimated Expiration
Slovenia1027329<disabled in preview>
Honduras1998000165<disabled in preview>
Uruguay25222<disabled in preview>
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Supplementary Protection Certificates for Tradename: TIKOSYN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/005Belgium<disabled>PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 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
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
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