ZURAMPIC Drug Patent Profile
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Which patents cover Zurampic, and what generic alternatives are available?
Zurampic 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-one countries.
The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.
DrugPatentWatch® Generic Entry Outlook for Zurampic
Zurampic was eligible for patent challenges on December 22, 2019.
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 ZURAMPIC
| International Patents: | 200 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Patent Applications: | 243 |
| Drug Prices: | Drug price information for ZURAMPIC |
| DailyMed Link: | ZURAMPIC at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZURAMPIC
Generic Entry Date for ZURAMPIC*:
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 ZURAMPIC
US Patents and Regulatory Information for ZURAMPIC
ZURAMPIC is protected by twelve US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZURAMPIC is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 ZURAMPIC
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A XANTHINE OXIDASE INHIBITOR ALONE
2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acet- ic acid and methyl ester
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF SERUM URIC ACID LEVELS
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ACHIEVING A THERAPEUTIC BENEFIT IN A SUBJECT WITH GOUT
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GOUT
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF SERUM URIC ACID LEVELS
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GOUT
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compounds and compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA
Treatment of gout and hyperuricemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COADMINISTERING WITH ALLOPURINOL TO REDUCE SERUM URIC ACID (SUA) BELOW 4 MG/DL; BELOW 6MG/DL IN PATIENTS HAVING URIC ACID DEPOSITS; AND/OR BELOW 6MG/DL WITH SUA INTRADAY CHANGE MORE THAN 50% AND/OR ADVERSE EVENT RATE LESS THAN 15%
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A XANTHINE OXIDASE INHIBITOR 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 | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 ZURAMPIC
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Grünenthal GmbH | Zurampic | lesinurad | EMEA/H/C/003932 Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone., |
Withdrawn | no | no | no | 2016-02-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZURAMPIC
When does loss-of-exclusivity occur for ZURAMPIC?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4639
Estimated Expiration: See Plans and Pricing
Australia
Patent: 11352129
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2013016982
Estimated Expiration: See Plans and Pricing
Canada
Patent: 17249
Estimated Expiration: See Plans and Pricing
China
Patent: 3298796
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0170187
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 18621
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 58846
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 2301
Estimated Expiration: See Plans and Pricing
Patent: 1370150
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 58846
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 31766
Estimated Expiration: See Plans and Pricing
Israel
Patent: 6367
Estimated Expiration: See Plans and Pricing
Japan
Patent: 81627
Estimated Expiration: See Plans and Pricing
Patent: 14501282
Estimated Expiration: See Plans and Pricing
Patent: 15172053
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 58846
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 2534
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 13007505
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0104
Estimated Expiration: See Plans and Pricing
Poland
Patent: 58846
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 58846
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 667
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 0902
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 58846
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1303253
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1541629
Estimated Expiration: See Plans and Pricing
Patent: 130105902
Estimated Expiration: See Plans and Pricing
Spain
Patent: 14914
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 52037
Estimated Expiration: See Plans and Pricing
Patent: 1302718
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 9172
Estimated Expiration: See Plans and Pricing
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 ZURAMPIC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2005280130 | S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase | See Plans and Pricing |
| Israel | 211428 | See Plans and Pricing | |
| South Korea | 20110050708 | COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZURAMPIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2217577 | C201930004 | Spain | See Plans and Pricing | PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823 |
| 2217577 | C20190007 00276 | Estonia | See Plans and Pricing | PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018 |
| 2135608 | C20160027 00203 | Estonia | See Plans and Pricing | PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016 |
| >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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