Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 14, 2019

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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 22nd, 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 29th, 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
Drug patent expirations by year for ZURAMPIC
Drug Prices for ZURAMPIC

See drug prices for ZURAMPIC

Generic Entry Opportunity Date for ZURAMPIC
Generic Entry Date for ZURAMPIC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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   Start Trial   Start Trial Y Y   Start Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ironwood Pharms Inc ZURAMPIC lesinurad TABLET;ORAL 207988-001 Dec 22, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZURAMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 2016/033 Ireland   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
McKinsey
Boehringer Ingelheim
Baxter
Merck

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