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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Moodys
QuintilesIMS
US Department of Justice
Cantor Fitzgerald
Cipla
Boehringer Ingelheim
Mallinckrodt
Chubb

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020505

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NDA 020505 describes TOPAMAX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the TOPAMAX profile page.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 020505
Tradename:TOPAMAX
Applicant:Janssen Pharms
Ingredient:topiramate
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020505
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPAMAX topiramate TABLET;ORAL 020505 NDA Janssen Pharmaceuticals, Inc. 50458-639 N 50458-639-65
TOPAMAX topiramate TABLET;ORAL 020505 NDA Janssen Pharmaceuticals, Inc. 50458-640 N 50458-640-65

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 24, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Dec 24, 1996TE:RLD:No

Expired US Patents for NDA 020505

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ➤ 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:

Medtronic
Accenture
US Army
Merck
Daiichi Sankyo
McKinsey
Cipla
Farmers Insurance
Cerilliant

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