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Last Updated: January 26, 2023

Lesinurad - Generic Drug Details


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

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-one countries.

Summary for lesinurad
International Patents:199
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 97
Clinical Trials: 19
Patent Applications: 424
DailyMed Link:lesinurad at DailyMed
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

International Patents for lesinurad

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 015846 2-[5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4Н-[1,2,4]ТРИАЗОЛ-3-ИЛСУЛЬФАНИЛ]УКСУСНАЯ КИСЛОТА И ЕЕ МЕТИЛОВЫЙ ЭФИР (2-[5-BROMO-4-CYCLOPROPYL NAPHTHALEN-1-YL)-4H-[1, 2, 4]TRIAZOL-3-YLSULFANYL] ACETIC ACID METHYL ESTER) See Plans and Pricing
Hong Kong 1133582 S-TRIAZOLYL ALPHA-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE S- See Plans and Pricing
Eurasian Patent Organization 201100441 СОЕДИНЕНИЯ ДЛЯ КОРРЕКЦИИ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ See Plans and Pricing
Lithuania PA2016024 See Plans and Pricing
Serbia 55667 POLIMORFNE FORME 2-(5-BROMO-4-(4-CILKOPROPILNAFTALEN-1-IL)-4H-1,2,4-TRIAZOL-3-ILTIO) SIRĆETNE KISELINE I NJIHOVA UPOTREBA (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lesinurad

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2217577 2019C/502 Belgium See Plans and Pricing PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
2217577 406 50001-2019 Slovakia See Plans and Pricing PRODUCT NAME: ALOPURINOL / LESINURAD; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2135608 34/2016 Austria See Plans and Pricing PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2217577 CR 2019 00003 Denmark See Plans and Pricing PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608 C20160027 00203 Estonia See Plans and Pricing PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016
>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.