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Last Updated: November 2, 2024

ALLOPURINOL; LESINURAD - Generic Drug Details


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

Allopurinol; 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.

Allopurinol; lesinurad has two hundred patent family members in forty-two countries.

Summary for ALLOPURINOL; LESINURAD
International Patents:200
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 7
DailyMed Link:ALLOPURINOL; LESINURAD at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALLOPURINOL; LESINURAD
Generic Entry Date for ALLOPURINOL; 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 ALLOPURINOL; LESINURAD

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

SponsorPhase
Ardea Biosciences, Inc.Phase 1
Ardea Biosciences, Inc.Phase 3

See all ALLOPURINOL; LESINURAD clinical trials

US Patents and Regulatory Information for ALLOPURINOL; 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 DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 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 ALLOPURINOL; LESINURAD

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Grunenthal GmbH Duzallo allopurinol, lesinurad EMEA/H/C/004412
Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.
Withdrawn no no no 2018-08-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ALLOPURINOL; LESINURAD

Country Patent Number Title Estimated Expiration
New Zealand 553534 S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase ⤷  Sign Up
Portugal 2582683 ⤷  Sign Up
European Patent Office 2658846 FORMES POLYMORPHES DE L'ACIDE 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACÉTIQUE ET LEURS UTILISATIONS (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF) ⤷  Sign Up
Ukraine 97139 2-(5-БРОМ-4-(4-ЦИКЛОПРОПІЛНАФТАЛІН-1-ІЛ)-4Н-[1,2,4]-ТРИАЗОЛ-3-ІЛСУЛЬФАНІЛ)ОЦТОВА КИСЛОТА ТА ЇЇ МЕТИЛОВИЙ ЕФІР[2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4Н-[1,2,4]-ТРИАЗОЛ-3-ИЛСУЛЬФАНИЛ)УКСУСНАЯ КИСЛОТА И ЕЕ МЕТИЛОВЫЙ ЭФИР (Normal;heading 1;heading 2;heading 3;2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND METHYL ESTER) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALLOPURINOL; LESINURAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2217577 CA 2019 00003 Denmark ⤷  Sign Up PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608 288 5019-2016 Slovakia ⤷  Sign Up PRODUCT NAME: LESINURAD VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1080 20160222
2135608 2016C/039 Belgium ⤷  Sign Up PRODUCT NAME: LESINURAD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1080 20160222
2582683 2019008 Norway ⤷  Sign Up PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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