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Topiramate - Generic Drug Details

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Topiramate is the generic ingredient in five branded drugs marketed by Janssen Pharms, Pliva Hrvatska Doo, Sandoz, Roxane, Lupin, Accord Hlthcare, Mylan, Barr, Teva, Upsher-smith Labs, Glenmark Generics, Sun Pharm Inds Ltd, Apotex Inc, Supernus Pharms, Zydus Pharms Usa Inc, Actavis Totowa, Cipla Ltd, Watson Labs, Torrent Pharms, Wockhardt Usa, Aurobindo Pharma, Invagen Pharms, Unichem Labs Ltd, Sun Pharma Global, Hikma Pharms, and Upsher Smith, and is included in thirty-two NDAs. There are fourteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-three patent family members in thirty-two countries.

There are twenty-six drug master file entries for topiramate. Fifty-eight suppliers are listed for this compound.

Summary for Generic Name: topiramate

Tradenames:5
Patents:14
Applicants:26
NDAs:32
Drug Master File Entries: see list26
Suppliers / Packaging: see list58
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
TOPIRAMATE
topiramate
CAPSULE;ORAL078877-002Oct 14, 2009RXNo► subscribe► subscribe
Sun Pharma Global
TOPIRAMATE
topiramate
TABLET;ORAL090278-003Mar 27, 2009RXNo► subscribe► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-006Dec 24, 1996DISCNNo5,998,380*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-006Dec 24, 19967,018,983*PED► subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-002Dec 24, 19967,018,983*PED► subscribe
Janssen Pharms
TOPAMAX SPRINKLE
topiramate
CAPSULE;ORAL020844-003Oct 26, 19987,018,983*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: topiramate

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 Ingredient: topiramate

Country Document Number Estimated Expiration
European Patent Office1973528► subscribe
Israel138032► subscribe
European Patent Office2394643► 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: TOPIRAMATE

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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