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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 five suppliers. There are five patents 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. Fifty-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for NDA: 020505

Tradename:
TOPAMAX
Applicant:
Janssen Pharms
Ingredient:
topiramate
Patents:4
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 Rebel Distributors Corp 21695-128 21695-128-15 15 TABLET, COATED in 1 BOTTLE (21695-128-15)
TOPAMAX
topiramate
TABLET;ORAL 020505 NDA Rebel Distributors Corp 21695-128 21695-128-60 60 TABLET, COATED in 1 BOTTLE (21695-128-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1996TE:ABRLD:Yes
Patent:5,998,380*PEDPatent Expiration:Apr 13, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,503,884*PEDPatent Expiration:Apr 13, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:7,018,983*PEDPatent Expiration:Apr 13, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020505

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-005Dec 24, 19967,018,983*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-002Dec 24, 19967,018,983*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-006Dec 24, 19966,503,884*PED► subscribe
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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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