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Last Updated: November 21, 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. Fifty-four 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
All India Institute of Medical Sciences, BhubaneswarPhase 4
Stanford UniversityEarly Phase 1
Université de SherbrookePhase 4

See all TOPAMAX clinical trials

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ⤷  Sign Up ⤷  Sign Up
>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
Denmark 173923 ⤷  Sign Up
Israel 138032 PHARMACEUTICAL COMPOSITION OF TOPIRAMATE ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9713510 ⤷  Sign Up
Taiwan 590778 ⤷  Sign Up
Australia 7443496 ⤷  Sign Up
Bulgaria 104727 ⤷  Sign Up
Argentina 017984 PROCESO PARA FORMAR UNA COMPOSICION FARMACEUTICA DE TOPIRAMATO Y COMPOSICION FARMACEUTICA DE TOPIRAMATO ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOPAMAX

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

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