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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Daiichi Sankyo
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Queensland Health
Federal Trade Commission
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020844

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NDA 020844 describes TOPAMAX SPRINKLE, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the TOPAMAX SPRINKLE profile page.

The generic ingredient in TOPAMAX SPRINKLE 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 020844
Tradename:TOPAMAX SPRINKLE
Applicant:Janssen Pharms
Ingredient:topiramate
Patents:1
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPAMAX topiramate CAPSULE;ORAL 020844 NDA Janssen Pharmaceuticals, Inc. 50458-645 N 50458-645-65
TOPAMAX topiramate CAPSULE;ORAL 020844 NDA Janssen Pharmaceuticals, Inc. 50458-647 N 50458-647-65

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Oct 26, 1998TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 1, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 26, 1998TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 1, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Oct 26, 1998TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Sep 1, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020844

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Covington
Accenture
QuintilesIMS
McKinsey
Cerilliant
Daiichi Sankyo
Healthtrust
Julphar

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