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Medtronic
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020931

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NDA 020931 describes TIKOSYN, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the TIKOSYN profile page.

The generic ingredient in TIKOSYN is dofetilide. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 020931
Tradename:TIKOSYN
Applicant:Pfizer
Ingredient:dofetilide
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020931
Suppliers and Packaging for NDA: 020931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIKOSYN dofetilide CAPSULE;ORAL 020931 NDA Pfizer Laboratories Div Pfizer Inc 0069-5800 N 0069-5800-43
TIKOSYN dofetilide CAPSULE;ORAL 020931 NDA Pfizer Laboratories Div Pfizer Inc 0069-5800 N 0069-5800-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 9, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 9, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 9, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020931

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

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Serving hundreds of leading biopharmaceutical companies globally:

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Cipla
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Boehringer Ingelheim
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Healthtrust

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