URIDINE TRIACETATE - Generic Drug Details
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What are the generic drug sources for uridine triacetate and what is the scope of freedom to operate?
Uridine triacetate
is the generic ingredient in two branded drugs marketed by Btg Intl and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Uridine triacetate has one hundred and seventy-five patent family members in twenty-one countries.
Two suppliers are listed for this compound.
Summary for URIDINE TRIACETATE
International Patents: | 175 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 2 |
Patent Applications: | 552 |
What excipients (inactive ingredients) are in URIDINE TRIACETATE? | URIDINE TRIACETATE excipients list |
DailyMed Link: | URIDINE TRIACETATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for URIDINE TRIACETATE
Generic Entry Date for URIDINE TRIACETATE*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for URIDINE TRIACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Wellstat Therapeutics | Phase 3 |
Wellstat Therapeutics |
Pharmacology for URIDINE TRIACETATE
Ingredient-type | Analogs/Derivatives Pyrimidines |
Drug Class | Pyrimidine Analog |
Anatomical Therapeutic Chemical (ATC) Classes for URIDINE TRIACETATE
US Patents and Regulatory Information for URIDINE TRIACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for URIDINE TRIACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for URIDINE TRIACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0339075 | ACYLATED URIDINE AND CYTIDINE AND USES THEREOF | ⤷ Sign Up |
Japan | 2894610 | ⤷ Sign Up | |
Denmark | 1491201 | ⤷ Sign Up | |
Mexico | 9203963 | AGENTES QUIMIOTERAPEUTICOS Y ANTIVIRALES CON TOXICIDAD REDUCIDA. | ⤷ Sign Up |
Australia | 712835 | ⤷ Sign Up | |
Norway | 317199 | ⤷ Sign Up | |
Japan | 2006096772 | OXYPURINE NUCLEOSIDE FOR IMPROVING HEMOPOIESIS, HOMOLOGUE THEREOF AND ACYL DERIVATIVE THEREOF | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for URIDINE TRIACETATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1849470 | CA 2017 00036 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
1849470 | 2017C/028 | Belgium | ⤷ Sign Up | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
2207786 | 2023C/551 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
1849470 | 1790063-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
1849470 | LUC00036 | Luxembourg | ⤷ Sign Up | 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 |
2207786 | LUC00327 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
2207786 | 301257 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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