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Last Updated: June 20, 2024

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 two hundred patent family members in forty-two countries.

Summary for lesinurad
International Patents:200
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
Ironwood Pharmaceuticals, Inc.Phase 4
Medpace, 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes 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

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
South Africa 201101626 COMPOUNDS,COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS ⤷  Sign Up
Eurasian Patent Organization 201370150 ПОЛИМОРФНЫЕ ФОРМЫ 2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4H-1,2,4-ТРИАЗОЛ-3-ИЛТИО)УКСУСНОЙ КИСЛОТЫ И ИХ ПРИМЕНЕНИЕ ⤷  Sign Up
Australia 2009289646 Compounds, compositions and methods of using same for modulating uric acid levels ⤷  Sign Up
European Patent Office 2433633 Triazolyl alpha-mercaptoacetanildes tenant lieu d'inhibiteurs de la transcriptase inverse VIH (Triazolyl alpha -mercaptoacetanildes as inhibitors of HIV reverse transcriptase) ⤷  Sign Up
Ecuador SP077322 S-TRIAZOLIL-ALFA-MERCAPTOACETANILIDAS COMO INHIBIDORES DE TRANSCRIPTASA INVERSA DE VIRUS DE INMUNODEFICIENCIA HUMANA ⤷  Sign Up
Norway 2019008 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lesinurad

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 16C0031 France ⤷  Sign Up PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222
2135608 122016000060 Germany ⤷  Sign Up PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577 2019C/502 Belgium ⤷  Sign Up 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 300970 Netherlands ⤷  Sign Up PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2135608 2016/033 Ireland ⤷  Sign Up PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608 288 5019-2016 Slovakia ⤷  Sign Up PRODUCT NAME: LESINURAD VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1080 20160222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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