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Serving 500+ biopharmaceutical companies globally:

McKinsey
Colorcon
Medtronic
Express Scripts
Covington
Cipla
Chubb
Boehringer Ingelheim
UBS
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Topiramate - Generic Drug Details

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What are the generic sources for topiramate and what is the scope of topiramate freedom to operate?

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, and Hikma Pharms, and is included in thirty-two NDAs. There are fifteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Topiramate has fifty-four patent family members in thirty-three countries.

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

Summary for Generic Name: topiramate

Tradenames:5
Patents:15
Applicants:25
NDAs:32
Drug Master File Entries: see list26
Suppliers / Packagers: see list53
Bulk Api Vendors: see list52
Clinical Trials: see list234
Patent Applications: see list5,408
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:topiramate at DailyMed

Tentative approvals for TOPIRAMATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe25MGTABLET;ORAL
► Subscribe► Subscribe200MGTABLET;ORAL
► Subscribe► Subscribe100MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Usa
TOPIRAMATE
topiramate
TABLET;ORAL090353-001Sep 1, 2010DISCNNoNo► Subscribe► Subscribe
Teva
TOPIRAMATE
topiramate
TABLET;ORAL076317-003Mar 27, 2009ABRXNoNo► Subscribe► Subscribe
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-004Aug 16, 2013RXYesYes8,877,248► SubscribeY ► Subscribe
Roxane
TOPIRAMATE
topiramate
TABLET;ORAL076306-001Mar 27, 2009DISCNNoNo► Subscribe► Subscribe
Torrent Pharms
TOPIRAMATE
topiramate
TABLET;ORAL079153-001Mar 27, 2009ABRXNoNo► Subscribe► 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;ORAL020505-001Dec 24, 19965,998,380*PED► Subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-002Dec 24, 19967,498,311*PED► Subscribe
Janssen Pharms
TOPAMAX
topiramate
CAPSULE;ORAL020844-002Oct 26, 19987,018,983*PED► Subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-006Dec 24, 19967,498,311*PED► Subscribe
Janssen Pharms
TOPAMAX
topiramate
TABLET;ORAL020505-004Dec 24, 19967,498,311*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
China1419444► Subscribe
Turkey200002541► Subscribe
Israel138032► Subscribe
Poland194559► Subscribe
Portugal1066027► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Baxter
Harvard Business School
Federal Trade Commission
US Department of Justice
Julphar
Express Scripts
Johnson and Johnson
Deloitte
QuintilesIMS

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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