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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
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Generated: November 19, 2017

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. Four suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 020931

Tradename:
1
Applicant:
1
Ingredient:
1
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 0069-5800-43 40 BLISTER PACK in 1 CARTON (0069-5800-43) > 1 CAPSULE in 1 BLISTER PACK
TIKOSYN
dofetilide
CAPSULE;ORAL 020931 NDA Pfizer Laboratories Div Pfizer Inc 0069-5800 0069-5800-60 60 CAPSULE in 1 BOTTLE (0069-5800-60)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020931

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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
McKinsey
UBS
Cantor Fitzgerald
Accenture
Dow
QuintilesIMS
Covington
Chubb

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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