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TOPAMAX Drug Profile

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Topamax 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.

This drug has thirty-seven patent family members in thirty countries.

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 Tradename: TOPAMAX

Patents:5
Applicants:1
NDAs:2
Suppliers / Packagers: see list5
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
TOPAMAX
topiramate
CAPSULE;ORAL020844-002Oct 26, 1998RXYes7,498,311*PED► subscribeY► subscribe
Janssen Pharms
TOPAMAX
topiramate
CAPSULE;ORAL020844-001Oct 26, 1998RXNo6,503,884*PED► subscribeY► subscribe
Janssen Pharms
TOPAMAX SPRINKLE
topiramate
CAPSULE;ORAL020844-003Oct 26, 1998DISCNNo7,018,983*PED► subscribeY► subscribe
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Expired Patents for Tradename: TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-001Dec 24, 19966,503,884*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-003Dec 24, 19967,498,311*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-005Dec 24, 19967,498,311*PED► subscribe
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Paragraph IV activity for: TOPAMAX

Drugname Dosage Strength RLD Submissiondate
topiramateTablets50 mgTopamax9/8/2005
topiramateCapsules15 mg and 25 mgTopamax Sprinkle9/7/2005
topiramateTablets25 mg, 100 mg and 200 mgTopamax12/26/2001

Non-Orange Book Patents for Tradename: TOPAMAX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,696,091 Pharmaceutical composition of topiramate► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TOPAMAX

Country Document Number Estimated Expiration
Malaysia125821► subscribe
Norway20004311► subscribe
Denmark1066027► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TOPAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/028United Kingdom► subscribePRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
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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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