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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 eight 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:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
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	209203-001	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

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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
8,344,012	Compounds, compositions and methods of using same for modulating uric acid levels
8,252,828	S-triazolyl .alpha.-mercapto acetanilides as inhibitors of HIV reverse transcriptase
8,481,581	S-triazolyl .alpha.-mercaptoacetanilides 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

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International Patents for DUZALLO

Country	Document Number	Estimated Expiration
Ukraine	102826
Eurasian Patent Organization	200901186
European Patent Office	2842948
Mexico	2007002236

Supplementary Protection Certificates for DUZALLO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90033-4	Sweden		PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REG. NO/DATE: EU/1/15/1080 20160222
2016024,C2135608	Lithuania		PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218
169	Luxembourg		PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222
2016024	Lithuania		PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218