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Last Updated: September 26, 2022

TOPAMAX Drug Patent Profile


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Which patents cover Topamax, and what generic alternatives are available?

Topamax is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Topamax

A generic version of TOPAMAX was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.

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Drug patent expirations by year for TOPAMAX
Drug Prices for TOPAMAX

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Drug Sales Revenue Trends for TOPAMAX

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Recent Clinical Trials for TOPAMAX

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SponsorPhase
Stanford UniversityEarly Phase 1
Université de SherbrookePhase 4
University of Colorado- Nutrition Obesity Research CenterPhase 2

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Anatomical Therapeutic Chemical (ATC) Classes for TOPAMAX
Paragraph IV (Patent) Challenges for TOPAMAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TOPAMAX Tablets topiramate 50 mg 020505 1 2005-09-08
TOPAMAX Tablets topiramate 25 mg, 100 mg and 200 mg 020505 2001-12-26

US Patents and Regulatory Information for TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes 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 TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 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 020505-005 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TOPAMAX

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
0138441 97C0097 Belgium See Plans and Pricing PRODUCT NAME: TOPIRAMAAT; NAT. REGISTRATION NO/DATE: 1028 IS 71 F 3 19970616; FIRST REGISTRATION: GB PL/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.