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Last Updated: October 29, 2020

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XURIDEN Drug Profile

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When do Xuriden patents expire, and what generic alternatives are available?

Xuriden is a drug marketed by Wellstat Therap and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

US ANDA Litigation and Generic Entry Outlook for Xuriden

Xuriden was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XURIDEN
International Patents:175
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 57
Patent Applications: 77
Formulation / Manufacturing:see details
DailyMed Link:XURIDEN at DailyMed
Drug patent expirations by year for XURIDEN
Generic Entry Opportunity Date for XURIDEN
Generic Entry Date for XURIDEN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;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 XURIDEN

US Patents and Regulatory Information for XURIDEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial   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 XURIDEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 2017/033 Ireland   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 CA 2017 00036 Denmark   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 1790063-0 Sweden   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium   Start Trial PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 17C1028 France   Start Trial PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Express Scripts
McKesson
AstraZeneca
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.