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Last Updated: March 18, 2024

Lesinurad - Generic Drug Details


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What are the generic drug sources for lesinurad and what is the scope of freedom to operate?

Lesinurad is the generic ingredient in one branded drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lesinurad has one hundred and ninety-nine patent family members in forty-two countries.

Summary for lesinurad
International Patents:199
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
Clinical Trials: 19
Patent Applications: 333
DailyMed Link:lesinurad at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lesinurad
Generic Entry Date for lesinurad*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for lesinurad

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

SponsorPhase
Medpace, Inc.Phase 4
Ironwood Pharmaceuticals, Inc.Phase 4
Ardea Biosciences, Inc.Phase 1

See all lesinurad clinical trials

US Patents and Regulatory Information for lesinurad

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes 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

EU/EMA Drug Approvals for lesinurad

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Grünenthal GmbH Zurampic lesinurad EMEA/H/C/003932
Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,
Withdrawn no no no 2016-02-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for lesinurad

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2217577 300970 Netherlands ⤷  Try a Trial PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2135608 C02135608/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017
2135608 PA2016024,C2135608 Lithuania ⤷  Try a Trial PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608 2016C/039 Belgium ⤷  Try a Trial PRODUCT NAME: LESINURAD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1080 20160222
2217577 2016016 Norway ⤷  Try a Trial PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.