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ZURAMPIC Drug Profile

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When do Zurampic patents expire, and when can generic versions of Zurampic launch?

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-five patent family members in forty-one countries.

The generic ingredient in ZURAMPIC is lesinurad. One supplier is listed for this compound. Additional details are available on the lesinurad profile page.

US ANDA Litigation and Generic Entry Outlook for Zurampic

Zurampic will be eligible for patent challenges on December 22^nd, 2019. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

Summary for ZURAMPIC

International Patents:	195
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	63
Patent Applications:	67
Drug Prices:	Drug price information for ZURAMPIC
DailyMed Link:	ZURAMPIC at DailyMed

See drug prices for ZURAMPIC

Generic Entry Opportunity 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.

Pharmacology for ZURAMPIC

Drug Class	Urate Transporter 1 Inhibitor
Mechanism of Action	Urate Transporter 1 Inhibitors Cytochrome P450 3A Inducers

Synonyms for ZURAMPIC

(5-bromo-4-(1-cyclopropylnaphthalen-4-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid

{[5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl]sulfanyl}acetic acid

09ERP08I3W

2-((5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl)thio)acetic acid

2-(5-bromo-4-(1-cyclopropylnaphthalen-4-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid

2-(5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid

2-[[5-Bromo-4-(4-cyclopropyl-1-naphthalenyl)-4H-1,2,4-triazol-3-yl]thio]-acetic acid

2-[[5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-1,2,4-triazol-3-yl]sulfanyl]acetic acid

2-[[5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl]thio]acetic acid

2-{[5-broMo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl]sulfanyl}acetic acid

3777AH

878672-00-5

AC-29310

Acetic acid, 2-((5-bromo-4-(4-cyclopropyl-1-naphthalenyl)-4H-1,2,4-triazol-3-yl)thio)-

Acetic acid,[[5-bromo-4-(4-cyclopropyl-1-naphthalenyl)-4H-1,2,4-triazol-3-yl]thio]-

ACN-050764

AK323774

AKOS027327368

BCP06435

BDBM37953

C17H14BrN3O2S

CHEBI:90929

CHEMBL2105720

CS-1389

D09921

DB11560

EX-A1289

FGQFOYHRJSUHMR-UHFFFAOYSA-N

GTPL7673

HY-15258

KB-78121

KS-00000LAE

LESINURAD

Lesinurad (RDEA-594)

Lesinurad (RDEA594 pound(c)

Lesinurad (RDEA594)

Lesinurad (USAN/INN)

Lesinurad [USAN:INN]

Lesinurad, >=98% (HPLC)

MolPort-039-138-666

RDEA 594

RDEA-594

RDEA594

s4640

SB16705

SC-94287

SCHEMBL842962

UNII-09ERP08I3W

US10093631, Compound Lesinurad

W-5949

ZINC84757007

Zurampic (TN)

US Patents and Regulatory Information for 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			Y	Y
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				Y

International Patents for ZURAMPIC

Country	Patent Number	Estimated Expiration
Norway	2019008
Taiwan	201302718
Ecuador	SP077322
Netherlands	300825

Supplementary Protection Certificates for ZURAMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	2016/033	Ireland		PRODUCT NAME: (I)PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED:-LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	300970	Netherlands		PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2217577	2019C/502	Belgium		PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303