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 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

See all lesinurad clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for lesinurad

M04AB	Preparations increasing uric acid excretion
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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				Y
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who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,	Withdrawn	no	no	no	2016-02-18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
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)
Hong Kong	1133582	S-TRIAZOLYL ALPHA-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE S-
Eurasian Patent Organization	201100441	СОЕДИНЕНИЯ ДЛЯ КОРРЕКЦИИ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Lithuania	PA2016024
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)

Supplementary Protection Certificates for lesinurad

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	2019C/502	Belgium		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		PRODUCT NAME: ALOPURINOL / LESINURAD; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2135608	34/2016	Austria		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2217577	CR 2019 00003	Denmark		PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	C20160027 00203	Estonia		PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016