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
Generic Entry Date for LESINURAD*:
Constraining patent/regulatory exclusivity:
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.
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 |
US Patents and Regulatory Information for LESINURAD
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Withdrawn | no | no | no | 2016-02-18 | |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 |
---|---|---|---|
Ecuador | SP10010310 | NUEVOS COMPUESTOS Y COMPOSICIONES Y MÉTODOS DE USO | ⤷ Try a Trial |
Croatia | P20180780 | ⤷ Try a Trial | |
Lithuania | C2135608 | ⤷ Try a Trial | |
Norway | 2016016 | ⤷ Try a Trial | |
Brazil | PI0819847 | compostos e composições e métodos de uso | ⤷ Try a Trial |
Ukraine | 102826 | ПРОИЗВОДНЫЕ ТРИАЗОЛА И ИХ ПРИМЕНЕНИЕ КАК ЛЕКАРСТВЕННОГО СРЕДСТВА;ПОХІДНІ ТРИАЗОЛУ ТА ЇХ ЗАСТОСУВАННЯ ЯК ЛІКАРСЬКОГО ЗАСОБУ (TRIAZOLE DERIVATIVES AND USE THEREOF AS A MEDICAMENT) | ⤷ Try a Trial |
Austria | E528001 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LESINURAD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2135608 | C02135608/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017 |
2217577 | 2019C/502 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
2217577 | 2016016 | Norway | ⤷ Try a Trial | PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303 |
2135608 | CR 2016 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
2135608 | SPC/GB16/045 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222 |
2135608 | CA 2016 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
2217577 | 7/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |