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
International Patents: | 175 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Patent Applications: | 267 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in XURIDEN? | XURIDEN excipients list |
DailyMed Link: | XURIDEN at DailyMed |

DrugPatentWatch® Estimated 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
Ingredient-type | Analogs/Derivatives Pyrimidines |
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting XURIDEN
TREATMENT OF HEREDITARY OROTIC ACIDURIA
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Wellstat Therap | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|
China | 1095268 | See Plans and Pricing | |
Spain | 2160579 | See Plans and Pricing | |
Australia | 6081294 | See Plans and Pricing | |
Germany | 3883374 | See Plans and Pricing | |
European Patent Office | 0594667 | TRAITEMENT D'UN AGENT CHIMIOTHERAPEUTIQUE ET DE LA TOXICITE D'UN AGENT ANTIVIRAL PAR DES NUCLEOSIDES DE PYRIMIDINE ACYLEE (TREATMENT OF CHEMOTHERAPEUTIC AGENT AND ANTIVIRAL AGENT TOXICITY WITH ACYLATED PYRIMIDINE NUCLEOSIDES) | See Plans and Pricing |
Australia | 3278495 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XURIDEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1849470 | 2017C/028 | Belgium | See Plans and Pricing | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
1849470 | 17C1028 | France | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
1849470 | CA 2017 00036 | Denmark | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
1849470 | LUC00036 | Luxembourg | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
1849470 | 300889 | Netherlands | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
1849470 | 2017/033 | Ireland | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |