LESINURAD - Generic Drug Details
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What are the generic sources for lesinurad and what is the scope of patent protection?
Lesinurad
is the generic ingredient in one branded drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lesinurad has two hundred patent family members in forty-two countries.
Summary for LESINURAD
| International Patents: | 200 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 19 |
| Patent Applications: | 333 |
| DailyMed Link: | LESINURAD at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LESINURAD
*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.
Recent Clinical Trials for LESINURAD
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medpace, Inc. | Phase 4 |
| Ironwood Pharmaceuticals, Inc. | Phase 4 |
| Ardea Biosciences, Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for LESINURAD
US Patents and Regulatory Information for LESINURAD
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | 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 LESINURAD
| 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 LESINURAD
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 553534 | S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase | ⤷ Sign Up |
| Portugal | 2582683 | ⤷ Sign Up | |
| European Patent Office | 2658846 | 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) | ⤷ Sign Up |
| Ukraine | 97139 | 2-(5-БРОМ-4-(4-ЦИКЛОПРОПІЛНАФТАЛІН-1-ІЛ)-4Н-[1,2,4]-ТРИАЗОЛ-3-ІЛСУЛЬФАНІЛ)ОЦТОВА КИСЛОТА ТА ЇЇ МЕТИЛОВИЙ ЕФІР[2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4Н-[1,2,4]-ТРИАЗОЛ-3-ИЛСУЛЬФАНИЛ)УКСУСНАЯ КИСЛОТА И ЕЕ МЕТИЛОВЫЙ ЭФИР (Normal;heading 1;heading 2;heading 3;2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND METHYL ESTER) | ⤷ Sign Up |
| Lithuania | C2135608 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LESINURAD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2217577 | CA 2019 00003 | Denmark | ⤷ Sign Up | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827 |
| 2135608 | 288 5019-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: LESINURAD VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1080 20160222 |
| 2135608 | 2016C/039 | Belgium | ⤷ Sign Up | PRODUCT NAME: LESINURAD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1080 20160222 |
| 2582683 | 2019008 | Norway | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904 |
| 2135608 | C20160027 00203 | Estonia | ⤷ Sign Up | PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
