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 |
|---|---|
| Medpace, Inc. | Phase 4 |
| Ironwood Pharmaceuticals, Inc. | Phase 4 |
| Ardea Biosciences, Inc. | Phase 1 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Austria | E540677 | ⤷ Try a Trial | |
| Montenegro | 01512 | S-triazolil alfa-merkaptoacetanilida kao inhibitori HIV reversne transkriptaze (S-triazolyl alpha-mercaptoacetanilides as inhibitors of HIV reverse transcriptase) | ⤷ Try a Trial |
| Australia | 2012203172 | Novel compounds and compositions and methods of use | ⤷ Try a Trial |
| Croatia | P20140950 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2010028189 | ⤷ Try a Trial | |
| Spain | 2614914 | ⤷ 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 | PA2016024,C2135608 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2135608 | 132016000081719 | Italy | ⤷ Try a Trial | PRODUCT NAME: LESINURAD, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZURAMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1080, 20160222 |
| 2582683 | 2019008 | Norway | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904 |
| 2217577 | 19C1004 | France | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2135608 | C02135608/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017 |
| 2217577 | C201930004 | Spain | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
