DUZALLO Drug Patent Profile
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Which patents cover Duzallo, and what generic alternatives are available?
Duzallo 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-two countries.
The generic ingredient in DUZALLO is allopurinol; lesinurad. There are twenty-two drug master file entries for this compound. Additional details are available on the allopurinol; lesinurad profile page.
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
AI Deep Research
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Summary for DUZALLO
International Patents: | 200 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Drug Prices: | Drug price information for DUZALLO |
DailyMed Link: | DUZALLO at DailyMed |


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 for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Croatia
Patent: 0170187
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 18621
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 58846
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Hungary
Patent: 31766
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 81627
Estimated Expiration: ⤷ Try for Free
Patent: 14501282
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Lithuania
Patent: 58846
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Poland
Patent: 58846
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 58846
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Slovenia
Patent: 58846
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
South Korea
Patent: 1541629
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Spain
Patent: 14914
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 52037
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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 |
---|---|---|---|
Ukraine | 109172 | ПОЛІМОРФНА ФОРМА 2-(5-БРОМ-4-(4-ЦИКЛОПРОПІЛНАФТАЛІН-1-ІЛ)-4H-1,2,4-ТРИАЗОЛ-3-ІЛТІО)ОЦТОВОЇ КИСЛОТИ (ВАРІАНТИ) ТА ЇЇ ЗАСТОСУВАННЯ | ⤷ Try for Free |
China | 101918377 | ⤷ Try for Free | |
Eurasian Patent Organization | 022301 | 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) | ⤷ Try for Free |
Brazil | PI0819847 | compostos e composições e métodos de uso | ⤷ Try for Free |
Japan | 2012077088 | S-TRIAZOLE α-MERCAPTOACETANILIDE AS INHIBITOR OF HIV REVERSE TRANSCRIPTASE | ⤷ Try for Free |
New Zealand | 601774 | ⤷ Try for Free | |
South Korea | 101291643 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DUZALLO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2217577 | C20190007 00276 | Estonia | ⤷ Try for Free | PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018 |
2135608 | C20160027 00203 | Estonia | ⤷ Try for Free | PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016 |
2135608 | 132016000081719 | Italy | ⤷ Try for Free | PRODUCT NAME: LESINURAD, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZURAMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1080, 20160222 |
2135608 | 93169 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222 |
2135608 | PA2016024 | Lithuania | ⤷ Try for Free | PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
2217577 | CR 2019 00003 | Denmark | ⤷ Try for Free | PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827 |
2135608 | 2016/033 | Ireland | ⤷ Try for Free | PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for DUZALLO
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