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Last Updated: May 10, 2024

Allopurinol; lesinurad - Generic Drug Details

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What are the generic sources for allopurinol; lesinurad and what is the scope of patent protection?

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

Anatomical Therapeutic Chemical (ATC) Classes for allopurinol; lesinurad

M04AA	Preparations inhibiting uric acid production
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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

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	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	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	209203-002	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
>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
Japan	4952943		⤷ Try a Trial
Eurasian Patent Organization	201270666	СОЕДИНЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ СНИЖЕНИЯ УРОВНЯ МОЧЕВОЙ КИСЛОТЫ	⤷ Try a Trial
China	103058944	Novel compound and composition	⤷ Try a Trial
Japan	2013528650		⤷ Try a Trial
South Africa	201101626	COMPOUNDS,COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS	⤷ Try a Trial
Eurasian Patent Organization	200901186	S-ТРИАЗОЛИЛ-α-МЕРКАПТОАЦЕТАНИЛИДЫ КАК ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ ВИЧ	⤷ Try a Trial
Taiwan	200927733	Novel compounds and compositions and methods of use	⤷ 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	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
2135608	93169	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222
2135608	SPC/GB16/045	United Kingdom	⤷ Try a Trial	PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222
2135608	122016000060	Germany	⤷ Try a Trial	PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	1990005-9	Sweden	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827
2135608	PA2016024	Lithuania	⤷ Try a Trial	PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	C20190007 00276	Estonia	⤷ Try a Trial	PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018
>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

Anatomical Therapeutic Chemical (ATC) Classes for allopurinol; lesinurad

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for allopurinol; lesinurad