duzallo Drug Patent Profile
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When do Duzallo patents expire, 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
Summary for duzallo
International Patents: | 200 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Formulation / Manufacturing: | see details |
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.
Anatomical Therapeutic Chemical (ATC) Classes for duzallo
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
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 |
---|---|---|---|
Australia | 2008329673 | Novel compounds and compositions and methods of use | ⤷ Try a Trial |
Serbia | 57275 | TRETMAN GIHTA I HIPERURIKEMIJE (TREATMENT OF GOUT AND HYPERURICEMIA) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2007050087 | ⤷ Try a Trial | |
Brazil | PI0918584 | compostos, composicoes e metodos de uso dos mesmos para modulacao dos niveis de acido urico | ⤷ Try a Trial |
New Zealand | 601774 | Substituted diazole and triazole compounds and compositions and methods of use | ⤷ Try a Trial |
European Patent Office | 2433633 | Triazolyl alpha-mercaptoacetanildes tenant lieu d'inhibiteurs de la transcriptase inverse VIH (Triazolyl alpha -mercaptoacetanildes as inhibitors of HIV reverse transcriptase) | ⤷ Try a Trial |
Morocco | 31936 | مركبات وتراكيب جديدة وطرق استخدامها | ⤷ 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 | 93169 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222 |
2135608 | CR 2016 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
2217577 | PA2019003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823 |
2217577 | 1990005-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
2135608 | C 2016 027 | Romania | ⤷ Try a Trial | PRODUCT NAME: LESINURAD SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1080; DATE OF NATIONAL AUTHORISATION: 20160218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1080; DATE OF FIRST AUTHORISATION IN EEA: 20160218 |
2217577 | 19C1004 | France | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
2217577 | C20190007 00276 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |