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Last Updated: June 9, 2023

XURIDEN Drug Patent 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.

DrugPatentWatch® 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
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Patent Applications: 385
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in XURIDEN?XURIDEN excipients list
DailyMed Link:XURIDEN at DailyMed
Drug patent expirations by year for XURIDEN
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

XURIDEN is protected by one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XURIDEN is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 XURIDEN

Acylated uridine and cytidine and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting XURIDEN

TREATMENT OF HEREDITARY OROTIC ACIDURIA
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for XURIDEN

See the table below for patents covering XURIDEN around the world.

Country Patent Number Title Estimated Expiration
Israel 107900 Composition comprising an acyl derivative of a pyrimidine nucleotide precursor and an inhibitor of uridine phosphorylase or/and a purine nucleotide precursor for use in treatment and prevention of systemic inflammation inflammatory hepatitis and similar conditions and use of such components in the manufacture of medicaments ⤷  Try a Trial
Japan 4408450 ⤷  Try a Trial
Australia 2254492 ⤷  Try a Trial
Germany 68910973 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XURIDEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 1790063-0 Sweden ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017/033 Ireland ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 SPC/GB17/049 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470 CA 2017 00036 Denmark ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. 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.