.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020844

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

Summary for NDA: 020844

Tradename:
TOPAMAX
Applicant:
Janssen Pharms
Ingredient:
topiramate
Patents:5
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 50458-645-65 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)
TOPAMAX SPRINKLE
topiramate
CAPSULE;ORAL 020844 NDA Janssen Pharmaceuticals, Inc. 50458-645 50458-645-65 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Oct 26, 1998TE:ABRLD:No
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: 020844

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TOPAMAX
topiramate
CAPSULE;ORAL020844-002Oct 26, 19987,498,311*PED► subscribe
Janssen Pharms
TOPAMAX SPRINKLE
topiramate
CAPSULE;ORAL020844-003Oct 26, 19985,998,380*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
CAPSULE;ORAL020844-001Oct 26, 19984,513,006*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc