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Last Updated: December 11, 2019

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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-five patent family members in forty-one countries.

There are twenty-two drug master file entries for allopurinol; lesinurad. One supplier is listed for this compound.

Summary for allopurinol; lesinurad
International Patents:195
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 22
Suppliers / Packagers: 1
Clinical Trials: 7
DailyMed Link:allopurinol; lesinurad at DailyMed
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   Start Trial   Start Trial   Start Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for allopurinol; lesinurad

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2217577 LUC00103 Luxembourg   Start Trial PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLES(S); AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
2217577 300970 Netherlands   Start Trial PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2217577 CR 2019 00003 Denmark   Start Trial PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608 300825 Netherlands   Start Trial PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow
Medtronic
Boehringer Ingelheim
Baxter
Mallinckrodt

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