LESINURAD - Generic Drug Details

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

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

See all LESINURAD clinical trials

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
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No				Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No			Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No

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

International Patents for LESINURAD

Country	Patent Number	Title	Estimated Expiration
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)
China	103819419	Compounds, compositions and methods of using same for modulating uric acid levels
South Africa	201300055	TREATMENT OF GOUT AND HYPERURICEMIA
Taiwan	I415840
Eurasian Patent Organization	201100440	СОЕДИНЕНИЯ, КОМПОЗИЦИИ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ ДЛЯ КОРРЕКЦИИ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ
Colombia	6331333	NOVEDOSOS DERIVADOS DE PIRAZOL Y TRIAZOL PARA TRASTORNOS DEL METABOLISMO DE ACIDO COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN
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.)

Supplementary Protection Certificates for LESINURAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	122016000060	Germany		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608	2016C/039	Belgium		PRODUCT NAME: LESINURAD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1080 20160222
2217577	SPC/GB19/006	United Kingdom		PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT, OR SALTS THEREOF, AND ALLOPURINOL; REGISTERED: UK EU/1/18/1300/001(NI) 20180827; UK EU/1/18/1300/002(NI) 20180827; UK EU/1/18/1300/003(NI) 20180827; UK EU/1/18/1300/004(NI) 20180827
2217577	CA 2019 00003	Denmark		PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	C 2016 027	Romania		PRODUCT NAME: LESINURAD SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1080; DATE OF NATIONAL AUTHORISATION: 20160218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1080; DATE OF FIRST AUTHORISATION IN EEA: 20160218
2135608	16C0031	France		PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222
2135608	1690033-4	Sweden		PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REG. NO/DATE: EU/1/15/1080 20160222