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Last Updated: June 23, 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds and compositions and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds and compositions and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  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 Y ⤷  Sign Up
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 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 ⤷  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 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
Patent: FORMAS POLIMORFICAS DE ACIDO 2-(5-BROMO-4-(4-CICLOPROPILNAFTALEN-1-IL)-4H-1,2,4-TRIAZOL-3-ILTIO)ACETICO Y USOS DEL MISMO
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11352129
Patent: Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-3ylthio)acetic acid and uses thereof
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013016982
Patent: formas polimórficas de ácido 2-(5-bromo-4-(4-ciclopropilnaftalen-1-il)-4h-1,2,4-triazol-3-iltio)acético e usos destes
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 17249
Patent: FORMES POLYMORPHES DE L'ACIDE 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIQUE 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)
Estimated Expiration: ⤷  Sign Up

China

Patent: 3298796
Patent: Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio) acetic acid and uses thereof
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170187
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18621
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 58846
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2301
Patent: ПОЛИМОРФНЫЕ ФОРМЫ 2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4H-1,2,4-ТРИАЗОЛ-3-ИЛТИО)УКСУСНОЙ КИСЛОТЫ И ИХ ПРИМЕНЕНИЕ (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 1370150
Patent: ПОЛИМОРФНЫЕ ФОРМЫ 2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4H-1,2,4-ТРИАЗОЛ-3-ИЛТИО)УКСУСНОЙ КИСЛОТЫ И ИХ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 58846
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31766
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6367
Patent: צורות פולימורפיות גבישיות של 2-(5-ברומו-4-(4-ציקלופרופילנפתלן -1-איל)-4h-4,2,1-טריאזול-3-אילתיאו) חומצה אצטית, תכשירי רוקחות מוצקים המכילים אותן ושיטות להכנתן (Polymorphic forms of crystalline polymorph of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)4h-1,2,4-triazol-3-ylthio) acetic acid, solid pharmaceutical compositions comprising them and a process for their preparation)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 81627
Estimated Expiration: ⤷  Sign Up

Patent: 14501282
Estimated Expiration: ⤷  Sign Up

Patent: 15172053
Patent: 2−(5−ブロモ−4−(4−シクロプロピルナフタレン−1−イル)−4H−1,2,4−トリアゾル−3−イルチオ)酢酸の多形形態およびその使用 (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 58846
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2534
Patent: POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 13007505
Patent: FORMAS POLIMORFICAS DE ACIDO 2-(5-BROMO-4-(4-CICLOPROPILNAFTALEN-1 -IL)-4H-1,2,4-TRIAZOL-3-ILTIO)ACETICO Y USOS DE LOS MISMOS. (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)- 4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0104
Patent: Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4h-1,2,4-triazol-3-ylthio) acetic acid and uses thereof
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 58846
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 58846
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 667
Patent: POLIMORFNE FORME 2-(5-BROMO-4-(4-CILKOPROPILNAFTALEN-1-IL)-4H-1,2,4-TRIAZOL-3-ILTIO) SIRĆETNE KISELINE I NJIHOVA UPOTREBA (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 0902
Patent: POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 58846
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1303253
Patent: POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YL-THIO)ACETIC ACID AND USES THEREOF
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1541629
Estimated Expiration: ⤷  Sign Up

Patent: 130105902
Patent: POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 14914
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 52037
Estimated Expiration: ⤷  Sign Up

Patent: 1302718
Patent: Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid and uses thereof
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 9172
Patent: ПОЛІМОРФНА ФОРМА 2-(5-БРОМ-4-(4-ЦИКЛОПРОПІЛНАФТАЛІН-1-ІЛ)-4H-1,2,4-ТРИАЗОЛ-3-ІЛТІО)ОЦТОВОЇ КИСЛОТИ (ВАРІАНТИ) ТА ЇЇ ЗАСТОСУВАННЯ
Estimated Expiration: ⤷  Sign Up

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
Singapore 155246 S-TRIAZOLYL α-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE ⤷  Sign Up
Australia 2012203172 Novel compounds and compositions and methods of use ⤷  Sign Up
South Korea 101411806 ⤷  Sign Up
Singapore 190902 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUZALLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 122016000060 Germany ⤷  Sign Up PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608 PA2016024,C2135608 Lithuania ⤷  Sign Up PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577 7/2019 Austria ⤷  Sign Up PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2217577 122019000008 Germany ⤷  Sign Up PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823
>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.