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
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
*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 ⤷ 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
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 11352129
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013016982
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 17249
Estimated Expiration: ⤷ Sign Up
China
Patent: 3298796
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
Estimated Expiration: ⤷ Sign Up
Patent: 1370150
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 58846
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 31766
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6367
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 81627
Estimated Expiration: ⤷ Sign Up
Patent: 14501282
Estimated Expiration: ⤷ Sign Up
Patent: 15172053
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 58846
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2534
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 13007505
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0104
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 58846
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 58846
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 667
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 0902
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 58846
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1303253
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1541629
Estimated Expiration: ⤷ Sign Up
Patent: 130105902
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 14914
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 52037
Estimated Expiration: ⤷ Sign Up
Patent: 1302718
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9172
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 |
|---|---|---|---|
| Poland | 2135608 | ⤷ Sign Up | |
| Croatia | P20170187 | ⤷ Sign Up | |
| France | 16C0031 | ⤷ Sign Up | |
| South Africa | 201003769 | NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018 |
| 2135608 | 122016000060 | Germany | ⤷ Sign Up | PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2135608 | SPC/GB16/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222 |
| 2135608 | 93169 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222 |
| >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.
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