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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
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 |
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 | Pyrimidines Analogs/Derivatives |
| Drug Class | Pyrimidine Analog |
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 |
International Patents for XURIDEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2158269 | Start Trial |
| Japan | 2637534 | Start Trial |
| Austria | 97574 | Start Trial |
| European Patent Office | 0570519 | Start Trial |
| Canada | 2444071 | Start Trial |
| Japan | 2584947 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
