Uridine triacetate - Generic Drug Details
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What are the generic sources for uridine triacetate and what is the scope of patent protection?
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 | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169-001 | Sep 4, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for uridine triacetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9413687 | ⤷ Subscribe | |
Hong Kong | 1004854 | ⤷ Subscribe | |
Japan | H06508846 | ⤷ Subscribe | |
Australia | 3571389 | ⤷ Subscribe | |
European Patent Office | 0771204 | ⤷ Subscribe | |
Japan | 2001270896 | OXYPURINE NUCLEOSIDE FOR HEMATOPOIETIC AMELIORATION, AND HOMOLOGUE THEREOF, AND THEIR ACYL DERIVATIVES | ⤷ Subscribe |
European Patent Office | 0768883 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for uridine triacetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2207786 | 2023C/551 | Belgium | ⤷ Subscribe | 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 | LUC00036 | Luxembourg | ⤷ Subscribe | 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 | 2023C/550 | Belgium | ⤷ Subscribe | PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
1849470 | 17C1028 | France | ⤷ Subscribe | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
1849470 | 300889 | Netherlands | ⤷ Subscribe | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
1849470 | 2017/033 | Ireland | ⤷ Subscribe | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
2207786 | 301256 | Netherlands | ⤷ Subscribe | PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Uridine triacetate Market Analysis and Financial Projection Experimental
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