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Generated: December 18, 2017

DrugPatentWatch Database Preview

TOPAMAX Drug Profile

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When do Topamax patents expire, and what generic alternatives are available?

Topamax is a drug marketed by Janssen Pharms and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has thirty-nine patent family members in thirty-one countries and one supplementary protection certificate in one country.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the topiramate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen PharmsTOPAMAXtopiramateCAPSULE;ORAL020844-001Oct 26, 1998ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-001Dec 24, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateCAPSULE;ORAL020844-002Oct 26, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAX SPRINKLEtopiramateCAPSULE;ORAL020844-003Oct 26, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-002Dec 24, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateCAPSULE;ORAL020844-001Oct 26, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateCAPSULE;ORAL020844-002Oct 26, 1998ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-005Dec 24, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-004Dec 24, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-006Dec 24, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-003Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-004Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-003Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-006Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-006Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-001Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-006Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-002Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-004Dec 24, 1996► Subscribe► Subscribe
Janssen PharmsTOPAMAXtopiramateTABLET;ORAL020505-004Dec 24, 1996► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Bulgaria104727► Subscribe
China1419444► Subscribe
Indonesia26982► Subscribe
Argentina048456► Subscribe
Estonia200000503► Subscribe
Slovenia1066027► Subscribe
Denmark1066027► Subscribe
Australia763643► Subscribe
Ukraine65607► Subscribe
Malaysia125821► 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
US Army
Queensland Health
Cantor Fitzgerald
Moodys
Mallinckrodt
Farmers Insurance
Teva
Harvard Business School

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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