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Last Updated: March 4, 2024

DUZALLO Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Duzallo

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 DUZALLO
Drug patent expirations by year for DUZALLO
Drug Prices for DUZALLO

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DUZALLO
Generic Entry Date for DUZALLO*:
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 DUZALLO

DUZALLO is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DUZALLO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 DUZALLO

Compounds and compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acet- ic acid and methyl ester
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds and compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

Compounds and compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

Compounds and compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds and compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

Treatment of gout and hyperuricemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL 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 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 209203-002 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
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 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 Y ⤷  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 DUZALLO

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 DUZALLO

When does loss-of-exclusivity occur for DUZALLO?

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

Argentina

Patent: 4639
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11352129
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013016982
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 17249
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3298796
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170187
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18621
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2301
Estimated Expiration: ⤷  Try a Trial

Patent: 1370150
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31766
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6367
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 81627
Estimated Expiration: ⤷  Try a Trial

Patent: 14501282
Estimated Expiration: ⤷  Try a Trial

Patent: 15172053
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2534
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 13007505
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0104
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 667
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 0902
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 58846
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1303253
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1541629
Estimated Expiration: ⤷  Try a Trial

Patent: 130105902
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 14914
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 52037
Estimated Expiration: ⤷  Try a Trial

Patent: 1302718
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 9172
Estimated Expiration: ⤷  Try a Trial

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 DUZALLO around the world.

Country Patent Number Title Estimated Expiration
Montenegro 01294 NOVA JEDINJENJA I KOMPOZICIJE I METODE UPOTREBE (NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE) ⤷  Try a Trial
South Korea 20110050709 COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS ⤷  Try a Trial
Hungary E038265 ⤷  Try a Trial
Tunisia 2010000237 NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE ⤷  Try a Trial
Denmark 2217577 ⤷  Try a Trial
Japan 5905934 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUZALLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 C02135608/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017
2217577 122019000008 Germany ⤷  Try a Trial PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2135608 122016000060 Germany ⤷  Try a Trial PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608 CR 2016 00034 Denmark ⤷  Try a Trial PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222
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
>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.