DUZALLO Drug Patent Profile

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 two hundred patent family members in forty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Duzallo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUZALLO

International Patents:	200
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DUZALLO
DailyMed Link:	DUZALLO at DailyMed

See drug prices for DUZALLO

DrugPatentWatch^® Estimated 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.

Anatomical Therapeutic Chemical (ATC) Classes for DUZALLO

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 DUZALLO

DUZALLO is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

EU/EMA Drug Approvals for DUZALLO

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

International Patents for DUZALLO

When does loss-of-exclusivity occur for DUZALLO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DUZALLO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2005280130	S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase
Israel	211428
South Korea	20110050708	COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS
Poland	2135608
Taiwan	201018463	Compounds, compositions and methods of using same for modulating uric acid levels

Supplementary Protection Certificates for DUZALLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	C201930004	Spain		PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823
2217577	C20190007 00276	Estonia		PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018
2135608	C20160027 00203	Estonia		PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016
2135608	CA 2016 00034	Denmark		PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222
2135608	SPC/GB16/045	United Kingdom		PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222