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Generated: May 30, 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 topiramate 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 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-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: topiramate

Drug Master File Entries: see list26
Suppliers / Packagers: see list56
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

Tentative approvals for TOPIRAMATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe25MGTABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms
TABLET;ORAL091185-001Nov 25, 2013DISCNNoNo► Subscribe► Subscribe
Wockhardt Usa
TABLET;ORAL090353-002Sep 1, 2010DISCNNoNo► Subscribe► Subscribe
TABLET;ORAL078410-003Sep 11, 2013ABRXNoNo► Subscribe► Subscribe
Wockhardt Usa
TABLET;ORAL090353-001Sep 1, 2010DISCNNoNo► Subscribe► Subscribe
Supernus Pharms
CAPSULE, EXTENDED RELEASE;ORAL201635-004Aug 16, 2013RXYesYes8,992,989► SubscribeY ► Subscribe
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