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Last Updated: July 21, 2024

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 six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Zydus, Zydus Pharms, Supernus Pharms, Janssen Pharms, Aurobindo Pharma Ltd, Barr, Fosun Pharma, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Azurity, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Mylan, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in forty-five NDAs. There are nineteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Topiramate has twenty-one patent family members in eleven countries.

There are twenty-six drug master file entries for topiramate. Fifty-two suppliers are listed for this compound. There are five 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
AbbViePhase 3
Leiden University Medical CenterPhase 2
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 2

See all TOPIRAMATE clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up100MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for TOPIRAMATE
Paragraph IV (Patent) Challenges for TOPIRAMATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPRONTIA Oral Solution topiramate 25 mg/mL 214679 1 2022-10-06
QUDEXY XR Extended-release Capsules topiramate 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg 205122 1 2015-12-24
TROKENDI XR Extended-release Capsules topiramate 25 mg, 50 mg, and 100 mg 201635 1 2014-05-12
TROKENDI XR Extended-release Capsules topiramate 200 mg 201635 1 2014-04-03
TOPAMAX Tablets topiramate 50 mg 020505 1 2005-09-08
TOPAMAX SPRINKLE Capsules topiramate 15 mg and 25 mg 020844 1 2005-09-07
TOPAMAX Tablets topiramate 25 mg, 100 mg and 200 mg 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
Cipla Ltd TOPIRAMATE topiramate TABLET;ORAL 076343-002 Mar 27, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-003 Aug 16, 2013 AB1 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Watson Labs TOPIRAMATE topiramate CAPSULE;ORAL 077868-002 Apr 15, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Roxane TOPIRAMATE topiramate TABLET;ORAL 076306-002 Mar 27, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 AB2 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm Inds Ltd TOPIRAMATE topiramate TABLET;ORAL 076327-003 Mar 27, 2009 DISCN No 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 TOPIRAMATE

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

International Patents for TOPIRAMATE

Country Patent Number Title Estimated Expiration
European Patent Office 2394643 Formulations à libération prolongée de topiramate (Sustained-release formulations of topiramate) ⤷  Sign Up
South Korea 20160124930 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Sign Up
South Korea 20200010608 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Sign Up
South Korea 20150132838 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Sign Up
Japan 2010510241 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2014143380 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOPIRAMATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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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