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 one hundred and ninety-nine patent family members in forty-one countries.
Summary for lesinurad
International Patents: | 199 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 19 |
Patent Applications: | 424 |
DailyMed Link: | lesinurad at DailyMed |
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 | 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 | |||
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 | |||
Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | 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 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 |
---|---|---|---|
Eurasian Patent Organization | 015846 | 2-[5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4Н-[1,2,4]ТРИАЗОЛ-3-ИЛСУЛЬФАНИЛ]УКСУСНАЯ КИСЛОТА И ЕЕ МЕТИЛОВЫЙ ЭФИР (2-[5-BROMO-4-CYCLOPROPYL NAPHTHALEN-1-YL)-4H-[1, 2, 4]TRIAZOL-3-YLSULFANYL] ACETIC ACID METHYL ESTER) | See Plans and Pricing |
Hong Kong | 1133582 | S-TRIAZOLYL ALPHA-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE S- | See Plans and Pricing |
Eurasian Patent Organization | 201100441 | СОЕДИНЕНИЯ ДЛЯ КОРРЕКЦИИ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ | See Plans and Pricing |
Lithuania | PA2016024 | See Plans and Pricing | |
Serbia | 55667 | POLIMORFNE FORME 2-(5-BROMO-4-(4-CILKOPROPILNAFTALEN-1-IL)-4H-1,2,4-TRIAZOL-3-ILTIO) SIRĆETNE KISELINE I NJIHOVA UPOTREBA (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO) ACETIC ACID AND USES THEREOF) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lesinurad
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2217577 | 2019C/502 | Belgium | See Plans and Pricing | 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 | 406 50001-2019 | Slovakia | See Plans and Pricing | PRODUCT NAME: ALOPURINOL / LESINURAD; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
2135608 | 34/2016 | Austria | See Plans and Pricing | PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222 |
2217577 | CR 2019 00003 | Denmark | See Plans and Pricing | PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827 |
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 |