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Last Updated: November 21, 2024

TOPIRAMATE Drug Patent Profile


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Which patents cover Topiramate, and when can generic versions of Topiramate launch?

Topiramate is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Natco, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt. and is included in forty-three NDAs.

The generic ingredient in TOPIRAMATE 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 Topiramate

A generic version of TOPIRAMATE was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.

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Drug patent expirations by year for TOPIRAMATE
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
Shalamar Institute of Health SciencesN/A
AbbViePhase 3
Henan Cancer HospitalPhase 2

See all TOPIRAMATE clinical trials

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
Ascent Pharms Inc TOPIRAMATE topiramate TABLET;ORAL 215414-001 Aug 26, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Invagen Pharms TOPIRAMATE topiramate TABLET;ORAL 079162-003 Mar 27, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd TOPIRAMATE topiramate CAPSULE;ORAL 218482-002 Jun 13, 2024 AB RX 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

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