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Last Updated: August 10, 2020

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TOPIRAMATE - Generic Drug Details

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What are the generic drug sources for topiramate and what is the scope of patent protection?

Topiramate is the generic ingredient in five branded drugs marketed by Upsher Smith Labs, Zydus Pharms, Supernus Pharms, Janssen Pharms, Barr, Fosun Pharma, Mylan, Teva, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Aurobindo Pharma, Cipla Ltd, Glenmark Generics, Hikma Pharms, Invagen Pharms, Lupin, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt Usa, and is included in thirty-three NDAs. There are fifteen 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. Thirty-five suppliers are listed for this compound. There are four 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

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

SponsorPhase
SK Chemicals Co., Ltd.Phase 1
University of MinnesotaPhase 2
Huadong HospitalN/A

See all TOPIRAMATE clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial50MGTABLET;ORAL
  Start Trial  Start Trial25MGTABLET;ORAL
  Start Trial  Start Trial200MGTABLET;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 NDA Submissiondate
QUDEXY XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 205122 2015-12-24
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-05-12
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-04-03
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 TOPIRAMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 BC RX Yes No   Start Trial   Start Trial Y   Start Trial
Torrent Pharms TOPIRAMATE topiramate TABLET;ORAL 079153-004 Mar 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB RX Yes No   Start Trial   Start Trial   Start Trial
Accord Hlthcare TOPIRAMATE topiramate TABLET;ORAL 076311-002 Mar 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms TOPIRAMATE topiramate CAPSULE, EXTENDED RELEASE;ORAL 207382-003 Nov 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB RX Yes No   Start Trial   Start Trial Y   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 TOPIRAMATE

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 CAPSULE;ORAL 020844-001 Oct 26, 1998   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 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 TABLET;ORAL 020505-004 Dec 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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