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Last Updated: March 28, 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 one hundred and ninety-nine patent family members in forty-two countries.

Summary for allopurinol; lesinurad
International Patents:199
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 209203-001 Aug 18, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 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 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

Supplementary Protection Certificates for allopurinol; lesinurad

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 132016000081719 Italy ⤷  Try a Trial PRODUCT NAME: LESINURAD, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZURAMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1080, 20160222
2217577 CR 2019 00003 Denmark ⤷  Try a Trial PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2217577 7/2019 Austria ⤷  Try a Trial PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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