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Last Updated: September 25, 2022

ZURAMPIC Drug Patent Profile


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Which patents cover Zurampic, and what generic alternatives are available?

Zurampic is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred patent family members in forty-one countries.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

DrugPatentWatch® Generic Entry Outlook for Zurampic

Zurampic was eligible for patent challenges on December 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZURAMPIC
International Patents:200
US Patents:9
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 96
Patent Applications: 243
Drug Prices: Drug price information for ZURAMPIC
DailyMed Link:ZURAMPIC at DailyMed
Drug patent expirations by year for ZURAMPIC
Drug Prices for ZURAMPIC

See drug prices for ZURAMPIC

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZURAMPIC
Generic Entry Date for ZURAMPIC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for ZURAMPIC

ZURAMPIC is protected by twelve US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZURAMPIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZURAMPIC

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A XANTHINE OXIDASE INHIBITOR ALONE

2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acet- ic acid and methyl ester
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF SERUM URIC ACID LEVELS

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ACHIEVING A THERAPEUTIC BENEFIT IN A SUBJECT WITH GOUT

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GOUT

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF SERUM URIC ACID LEVELS

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GOUT

Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)ace- tic acid and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA

Treatment of gout and hyperuricemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COADMINISTERING WITH ALLOPURINOL TO REDUCE SERUM URIC ACID (SUA) BELOW 4 MG/DL; BELOW 6MG/DL IN PATIENTS HAVING URIC ACID DEPOSITS; AND/OR BELOW 6MG/DL WITH SUA INTRADAY CHANGE MORE THAN 50% AND/OR ADVERSE EVENT RATE LESS THAN 15%

Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)ace- tic acid and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A XANTHINE OXIDASE INHIBITOR ALONE

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
>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 ZURAMPIC

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GrĂ¼nenthal 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 ZURAMPIC

When does loss-of-exclusivity occur for ZURAMPIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4639
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11352129
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013016982
Estimated Expiration: See Plans and Pricing

Canada

Patent: 17249
Estimated Expiration: See Plans and Pricing

China

Patent: 3298796
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170187
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18621
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 58846
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2301
Estimated Expiration: See Plans and Pricing

Patent: 1370150
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58846
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31766
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6367
Estimated Expiration: See Plans and Pricing

Japan

Patent: 81627
Estimated Expiration: See Plans and Pricing

Patent: 14501282
Estimated Expiration: See Plans and Pricing

Patent: 15172053
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 58846
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2534
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 13007505
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0104
Estimated Expiration: See Plans and Pricing

Poland

Patent: 58846
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 58846
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 667
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0902
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 58846
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1303253
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1541629
Estimated Expiration: See Plans and Pricing

Patent: 130105902
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14914
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 52037
Estimated Expiration: See Plans and Pricing

Patent: 1302718
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 9172
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZURAMPIC around the world.

Country Patent Number Title Estimated Expiration
Australia 2005280130 S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase See Plans and Pricing
Israel 211428 See Plans and Pricing
South Korea 20110050708 COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZURAMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2217577 C201930004 Spain See Plans and Pricing PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823
2217577 C20190007 00276 Estonia See Plans and Pricing PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018
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.