You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 020505


✉ Email this page to a colleague

« Back to Dashboard


NDA 020505 describes TOPAMAX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. 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. Fifty-four 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
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 50458-639-65 60 TABLET, COATED in 1 BOTTLE (50458-639-65)
TOPAMAX topiramate TABLET;ORAL 020505 NDA Janssen Pharmaceuticals, Inc. 50458-640 50458-640-65 60 TABLET, COATED in 1 BOTTLE (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 020505-004 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.