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DUZALLO Drug Profile

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Which patents cover Duzallo, and what generic alternatives are available?

Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and ninety patent family members in forty countries.

The generic ingredient in DUZALLO is allopurinol; lesinurad. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the allopurinol; lesinurad profile page.

Summary for DUZALLO

International Patents:	190
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DUZALLO
Prior Art and Litigation Support	Order Prior Art and Litigation support for DUZALLO
DailyMed Link:	DUZALLO at DailyMed

Generic Entry Opportunity Date for DUZALLO

NDA:

209203

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.

US Patents and Regulatory Information for DUZALLO

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		RX	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		RX	Yes	Yes				Y
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		RX	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		RX	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		RX	Yes	Yes
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		RX	Yes	No				Y
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		RX	Yes	Yes

International Patents for DUZALLO

Country	Patent Number	Estimated Expiration
Canada	2802407
China	103298796
Japan	4952943
Australia	2009289647
Eurasian Patent Organization	201100441
European Patent Office	2402011
Serbia	55667

Supplementary Protection Certificates for DUZALLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	34/2016	Austria		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2135608	300825	Netherlands		PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2135608	122016000060	Germany		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2135608	C20160027 00203	Estonia		PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016
2135608	1690033-4	Sweden		PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REG. NO/DATE: EU/1/15/1080 20160222
2135608	16C0031	France		PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222