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Last Updated: March 19, 2024

Topiramate - Generic Drug Details


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What are the generic 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, Glenmark Pharms Ltd, Par Pharm, 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, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Glenmark Generics, 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 eighteen 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. Forty-nine 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
Canisius-Wilhelmina HospitalPhase 2
Leiden University Medical CenterPhase 2

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;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 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
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma Pharms TOPIRAMATE topiramate TABLET;ORAL 091185-003 Nov 25, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pliva Hrvatska Doo TOPIRAMATE topiramate TABLET;ORAL 077905-003 Mar 30, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs TOPIRAMATE topiramate TABLET;ORAL 077643-002 Mar 27, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-004 Aug 16, 2013 AB1 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-003 Aug 16, 2013 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan TOPIRAMATE topiramate TABLET;ORAL 076314-003 Mar 27, 2009 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 topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 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
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for topiramate

Country Patent Number Title Estimated Expiration
South Korea 20200010608 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Try a Trial
Spain 2312308 ⤷  Try a Trial
European Patent Office 2968177 CAPSULE DE TOPIRAMATE À LIBÉRATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Try a Trial
European Patent Office 2394643 Formulations à libération prolongée de topiramate (Sustained-release formulations of topiramate) ⤷  Try a Trial
South Korea 102072618 ⤷  Try a Trial
South Korea 101674509 ⤷  Try a Trial
Canada 2905011 CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES) ⤷  Try a Trial
>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 ⤷  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 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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