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Last Updated: January 27, 2023

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 six branded drugs marketed by Upsher Smith Labs, Glenmark Pharms Ltd, Zydus Pharms, Supernus Pharms, Janssen Pharms, Barr, Fosun Pharma, Strides Pharma, Teva, Watson Labs, Zydus Pharms Usa Inc, Azurity, Accord Hlthcare, Actavis Totowa, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Glenmark Generics, Hikma Pharms, Invagen Pharms, Mylan, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in thirty-seven NDAs. There are sixteen 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-two suppliers are listed for this compound. There are five 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

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SponsorPhase
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 2
Radboud University Medical CenterPhase 2
Eurofarma Laboratorios S.A.Phase 3

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing25MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
EPRONTIA Oral Solution topiramate 25 mg/mL 214679 1 2022-10-06
QUDEXY XR Extended-release Capsules topiramate 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg 205122 1 2015-12-24
TROKENDI XR Extended-release Capsules topiramate 25 mg, 50 mg, and 100 mg 201635 1 2014-05-12
TROKENDI XR Extended-release Capsules topiramate 200 mg 201635 1 2014-04-03
TOPAMAX Tablets topiramate 50 mg 020505 1 2005-09-08
TOPAMAX SPRINKLE Capsules topiramate 15 mg and 25 mg 020844 1 2005-09-07
TOPAMAX Tablets topiramate 25 mg, 100 mg and 200 mg 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
Invagen Pharms TOPIRAMATE topiramate TABLET;ORAL 079162-002 Mar 27, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms Ltd TOPIRAMATE topiramate CAPSULE, EXTENDED RELEASE;ORAL 210278-002 Feb 1, 2021 AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms Usa Inc TOPIRAMATE topiramate TABLET;ORAL 078235-001 Mar 27, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt TOPIRAMATE topiramate TABLET;ORAL 090353-003 Sep 1, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020505-003 Dec 24, 1996 See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for topiramate

Country Patent Number Title Estimated Expiration
South Korea 20160124930 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) See Plans and Pricing
Spain 2555066 See Plans and Pricing
South Korea 101674509 See Plans and Pricing
European Patent Office 1973528 FORMULATIONS DE TOPIRAMATE À LIBÉRATION PROLONGÉE (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE) See Plans and Pricing
Mexico 2009001711 FORMULACIONES DE LIBERACION SOSTENIDA DE TOPIRAMATO. (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for topiramate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138441 SPC/GB95/028 United Kingdom See Plans and Pricing PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.