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Last Updated: March 28, 2024

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-nine 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

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

SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
Stanford UniversityEarly Phase 1
Université de SherbrookePhase 4

See all TOPAMAX clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 020505-004 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TOPAMAX

See the table below for patents covering TOPAMAX around the world.

Country Patent Number Title Estimated Expiration
Japan H055824 ⤷  Try a Trial
New Zealand 506532 Composition comprising a process of forming dried core particle topiramate coated with a taste masking substance followed by a binder further coated with a further taste masking substance and method for treating epilepsy and convulsions ⤷  Try a Trial
Hungary T36784 ⤷  Try a Trial
South Africa 9901716 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOPAMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 2190050-1 Sweden ⤷  Try a Trial PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
0138441 97C0097 Belgium ⤷  Try a Trial PRODUCT NAME: TOPIRAMAAT; NAT. REGISTRATION NO/DATE: 1028 IS 71 F 3 19970616; FIRST REGISTRATION: GB PL/0242/0301 19950718
0138441 SPC/GB95/028 United Kingdom ⤷  Try a Trial 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.