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Generated: April 23, 2017

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Topiramate - Generic Drug Details

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

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.

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

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

Summary for Generic Name: topiramate

Drug Master File Entries: see list26
Suppliers / Packagers: see list57
Bulk Api Vendors: see list52
Clinical Trials: see list52
Patent Applications: see list5,408
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:topiramate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms
CAPSULE, EXTENDED RELEASE;ORAL201635-001Aug 16, 2013RXYesNo8,992,989► SubscribeY ► Subscribe
Torrent Pharms
TABLET;ORAL079153-001Mar 27, 2009ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma
TABLET;ORAL078462-002Mar 27, 2009ABRXNoNo► Subscribe► Subscribe
Supernus Pharms
CAPSULE, EXTENDED RELEASE;ORAL201635-004Aug 16, 2013RXYesYes8,992,989► SubscribeY ► Subscribe
Upsher-smith Labs
CAPSULE, EXTENDED RELEASE;ORAL205122-002Mar 11, 2014RXYesNo8,652,527► SubscribeY ► Subscribe
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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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