ZURAMPIC Drug Patent Profile

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

Zurampic 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-eight patent family members in forty-one countries.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurampic

Zurampic was eligible for patent challenges on December 22, 2019.

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 ZURAMPIC

International Patents:	198
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	101
Patent Applications:	196
Drug Prices:	Drug price information for ZURAMPIC
DailyMed Link:	ZURAMPIC at DailyMed

See drug prices for ZURAMPIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZURAMPIC

NDA:

207988

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 ZURAMPIC

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

US Patents and Regulatory Information for ZURAMPIC

ZURAMPIC is protected by twelve 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 ZURAMPIC

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	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No				Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No

EU/EMA Drug Approvals for ZURAMPIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grünenthal GmbH	Zurampic	lesinurad	EMEA/H/C/003932 Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,	Withdrawn	no	no	no	2016-02-18

International Patents for ZURAMPIC

When does loss-of-exclusivity occur for ZURAMPIC?

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 ZURAMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
China	102186827	Compounds, compositions and methods of using same for modulating uric acid levels
Japan	4952943
Eurasian Patent Organization	022301	ПОЛИМОРФНЫЕ ФОРМЫ 2-(5-БРОМ-4-(4-ЦИКЛОПРОПИЛНАФТАЛИН-1-ИЛ)-4H-1,2,4-ТРИАЗОЛ-3-ИЛТИО)УКСУСНОЙ КИСЛОТЫ И ИХ ПРИМЕНЕНИЕ (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF)
Lithuania	PA2019003
Malaysia	172534	POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF

Supplementary Protection Certificates for ZURAMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	CR 2019 00003	Denmark		PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	PA2016024,C2135608	Lithuania		PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2135608	34/2016	Austria		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2135608	C20160027 00203	Estonia		PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016