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VISTOGARD Drug Patent Profile

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When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Btg Intl 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 VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vistogard

Vistogard 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 August 17, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VISTOGARD

International Patents:	175
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	287
Drug Prices:	Drug price information for VISTOGARD
What excipients (inactive ingredients) are in VISTOGARD?	VISTOGARD excipients list
DailyMed Link:	VISTOGARD at DailyMed

Drug patent expirations by year for VISTOGARD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VISTOGARD

Generic Entry Date for VISTOGARD^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208159 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 VISTOGARD

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VISTOGARD is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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 VISTOGARD

Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

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Glossary

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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	⤷ 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 VISTOGARD

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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	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 VISTOGARD

See the table below for patents covering VISTOGARD around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2009167213	METHOD OF DECREASING TOXICITY OF CHEMOTHERAPY AGENT AND ANTIVIRUS AGENT BY ACYLATED PYRIMIDINE NUCLEOSIDE	⤷ Sign Up
World Intellectual Property Organization (WIPO)	8903838		⤷ Sign Up
Australia	2722688		⤷ Sign Up
Canada	2588495	UTILITE DES NUCLEOSIDES D'URIDINE POUR TRAITER L'EMACIATION (THE UTILITY OF URIDINE NUCLEOSIDES IN THE TREATMENT OF CACHEXIA)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VISTOGARD

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	LUC00326	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
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	2023C/550	Belgium	⤷ Sign Up	PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	301256	Netherlands	⤷ Sign Up	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