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
Summary for XURIDEN
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||73|
|Formulation / Manufacturing:||see details|
|What excipients (inactive ingredients) are in XURIDEN?||XURIDEN excipients list|
|DailyMed Link:||XURIDEN at DailyMed|
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XURIDEN
Generic Entry Date for XURIDEN*:
Constraining patent/regulatory exclusivity:
*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
|Drug Class||Pyrimidine Analog|
Anatomical Therapeutic Chemical (ATC) Classes 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|