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Last Updated: July 12, 2020

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TOPAMAX Drug 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. Thirty-five suppliers are listed for this compound. Additional details are available on the topiramate profile page.

US ANDA 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
University of Colorado- Nutrition Obesity Research CenterPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Jaime Moore, MD MPHPhase 2

See all TOPAMAX clinical trials

Paragraph IV (Patent) Challenges for TOPAMAX
Tradename Dosage Ingredient NDA Submissiondate
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 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   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes No   Start Trial   Start Trial   Start 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 020505-005 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998   Start Trial   Start Trial
>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 97C0097 Belgium   Start 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   Start Trial 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:

Harvard Business School
Express Scripts
Mallinckrodt
Johnson and Johnson
Medtronic
Dow

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