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Last Updated: May 17, 2024

ALLOPURINOL; LESINURAD - Generic Drug Details

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What are the generic sources for allopurinol; lesinurad and what is the scope of freedom to operate?

Allopurinol; 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.

Allopurinol; lesinurad has two hundred patent family members in forty-two countries.

Summary for ALLOPURINOL; LESINURAD

International Patents:	200
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	7
DailyMed Link:	ALLOPURINOL; LESINURAD at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALLOPURINOL; LESINURAD

Generic Entry Date for ALLOPURINOL; LESINURAD^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 ALLOPURINOL; LESINURAD

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ardea Biosciences, Inc.	Phase 1
Ardea Biosciences, Inc.	Phase 3

See all ALLOPURINOL; LESINURAD clinical trials

US Patents and Regulatory Information for ALLOPURINOL; LESINURAD

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Glossary

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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	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ 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 ALLOPURINOL; LESINURAD

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grunenthal GmbH	Duzallo	allopurinol, lesinurad	EMEA/H/C/004412 Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.	Withdrawn	no	no	no	2018-08-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ALLOPURINOL; LESINURAD

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201100441	СОЕДИНЕНИЯ ДЛЯ КОРРЕКЦИИ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ	⤷ Try a Trial
China	103058944	Novel compound and composition	⤷ Try a Trial
European Patent Office	2328874	COMPOSÉS, COMPOSITIONS, ET PROCÉDÉS D'UTILISATION, PERMETTANT DE MODULER LES TAUX D'ACIDE URIQUE (COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS)	⤷ Try a Trial
China	102186827	Compounds, compositions and methods of using same for modulating uric acid levels	⤷ Try a Trial
Cyprus	1118621		⤷ Try a Trial
South Korea	20120084787	NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE	⤷ Try a Trial
Denmark	2582683		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALLOPURINOL; LESINURAD

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	CA 2019 00003	Denmark	⤷ Try a Trial	PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
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
2217577	CR 2019 00003	Denmark	⤷ Try a Trial	PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	1690033-4	Sweden	⤷ Try a Trial	PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REG. NO/DATE: EU/1/15/1080 20160222
2135608	34/2016	Austria	⤷ Try a Trial	PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2135608	SPC/GB16/045	United Kingdom	⤷ Try a Trial	PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222
2217577	2019C/502	Belgium	⤷ Try a Trial	PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for ALLOPURINOL; LESINURAD

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALLOPURINOL; LESINURAD

Recent Clinical Trials for ALLOPURINOL; LESINURAD

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALLOPURINOL; LESINURAD