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Last Updated: October 23, 2021

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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 patent protection?

Topiramate is the generic ingredient in five branded drugs marketed by Upsher Smith Labs, Glenmark Pharms Ltd, Zydus Pharms, Supernus Pharms, Janssen Pharms, Barr, Fosun Pharma, Mylan, Teva, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Glenmark Generics, Hikma Pharms, Invagen Pharms, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt Usa, and is included in thirty-five 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 twenty-two patent family members in eleven countries.

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

Drug Prices for topiramate

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Drug Sales Revenue Trends for topiramate

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Recent Clinical Trials for topiramate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MinnesotaPhase 3
University of MinnesotaEarly Phase 1
Industria FarmacĂȘutica Health MedsPhase 4

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free200MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free100MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for TOPIRAMATE
Tradename Dosage Ingredient NDA Submissiondate
QUDEXY XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 205122 2015-12-24
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-05-12
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-04-03
TOPAMAX TABLET;ORAL topiramate 020505 2005-09-08
TOPAMAX CAPSULE;ORAL topiramate 020844 2005-09-07
TOPAMAX SPRINKLE CAPSULE;ORAL topiramate 020844 2005-09-07
TOPAMAX TABLET;ORAL topiramate 020505 2001-12-26

US Patents and Regulatory Information for topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell TOPIRAMATE topiramate TABLET;ORAL 078410-003 Sep 11, 2013 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 AB1 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Zydus Pharms Usa Inc TOPIRAMATE topiramate TABLET;ORAL 078235-004 Mar 27, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-005 Mar 11, 2014 AB2 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Accord Hlthcare TOPIRAMATE topiramate TABLET;ORAL 076311-004 Mar 27, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for topiramate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138441 SPC/GB95/028 United Kingdom ⤷  Try it Free PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Johnson and Johnson
McKinsey
Mallinckrodt
Dow

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 verification 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.