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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 seven patents protecting this drug.

This drug has one hundred and seventy-five patent family members in thirty-eight 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:	175
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	DUZALLO at DailyMed

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	209203-001	Aug 18, 2017		RX	Yes	No				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	209203-002	Aug 18, 2017		RX	Yes	Yes			Y

Non-Orange Book US Patents for DUZALLO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,947,721	S-triazolyl .alpha.-mercaptoacetanilides as inhibitors of HIV reverse transcriptase
8,106,205	N[S(4-aryl-triazol-3-yl).alpha.-mercaptoacetyl]p-amino benzoic acids as HIV reverse transcriptase inhibitors
8,252,828	S-triazolyl .alpha.-mercapto acetanilides as inhibitors of HIV reverse transcriptase
7,435,752	N[S(4-aryl-triazol-3-yl).alpha.-mercaptoacetyl]-p-amino benozioc acids as HIV reverse transcriptase inhibitors

International Patents for DUZALLO

Country	Document Number	Estimated Expiration
Taiwan	I452037
Portugal	2217577
Israel	181523
Eurasian Patent Organization	201370150

Supplementary Protection Certificates for DUZALLO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2016	Austria		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
0825	Netherlands		PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222
2016000060	Germany		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
0160027 00203	Estonia		PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016