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 |
|---|---|
| Ironwood Pharmaceuticals, Inc. | Phase 4 |
| Medpace, 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 | Y | ⤷ Sign Up | |||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
|---|---|---|---|
| Montenegro | 01294 | NOVA JEDINJENJA I KOMPOZICIJE I METODE UPOTREBE (NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE) | ⤷ Sign Up |
| Cyprus | 1118621 | ⤷ Sign Up | |
| Mexico | 2011002450 | COMPUESTOS, COMPOSICIONES Y MÉTODOS PARA UTILIZAR LOS MISMOS PARA MODULAR NIVELES DE ÁCIDO ÚRICO. (COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS.) | ⤷ Sign Up |
| South Korea | 20110050708 | COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS | ⤷ Sign Up |
| Norway | 2019008 | ⤷ Sign Up | |
| Taiwan | I377200 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lesinurad
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2135608 | PA2016024,C2135608 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2217577 | 1990005-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
| 2217577 | 7/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2217577 | 132019000000023 | Italy | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOLO/LESINURAD, O UN LORO SALE FARMACEUTICAMENTE ACCETTABILE O LORO SALI FARMACEUTICAMENTE ACCETTABILI(DUZALLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1300, 20180827 |
| 2217577 | 300970 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2217577 | 2019C/502 | Belgium | ⤷ Sign Up | PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
