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
Ironwood Pharmaceuticals, Inc.	Phase 4
Medpace, 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			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
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	Y

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
Australia	2008329673	Novel compounds and compositions and methods of use
Serbia	57275	TRETMAN GIHTA I HIPERURIKEMIJE (TREATMENT OF GOUT AND HYPERURICEMIA)
World Intellectual Property Organization (WIPO)	2007050087
Brazil	PI0918584	compostos, composicoes e metodos de uso dos mesmos para modulacao dos niveis de acido urico
New Zealand	601774	Substituted diazole and triazole compounds and compositions and methods of use
European Patent Office	2433633	Triazolyl alpha-mercaptoacetanildes tenant lieu d'inhibiteurs de la transcriptase inverse VIH (Triazolyl alpha -mercaptoacetanildes as inhibitors of HIV reverse transcriptase)
Morocco	31936	مركبات وتراكيب جديدة وطرق استخدامها

Supplementary Protection Certificates for LESINURAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	93169	Luxembourg		PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222
2135608	CR 2016 00034	Denmark		PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	1990005-9	Sweden		PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/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
2217577	19C1004	France		PRODUCT NAME: ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2217577	C20190007 00276	Estonia		PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018