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. One supplier is 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
Summary for VISTOGARD
| International Patents: | 175 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Patent Applications: | 287 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VISTOGARD |
| What excipients (inactive ingredients) are in VISTOGARD? | VISTOGARD excipients list |
| DailyMed Link: | VISTOGARD at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
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 VISTOGARD
| Ingredient-type | Analogs/Derivatives Pyrimidines |
| Drug Class | Pyrimidine Analog |
Anatomical Therapeutic Chemical (ATC) Classes for VISTOGARD
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 610315 | ⤷ Try a Trial | |
| Japan | H0635389 | ⤷ Try a Trial | |
| Australia | 2915095 | ⤷ Try a Trial | |
| Russian Federation | 2115410 | COMPOSITION, METHOD OF HEALING STIMULATION | ⤷ Try a Trial |
| Spain | 2160579 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 9604923 | ⤷ Try a Trial | |
| Japan | 3393645 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VISTOGARD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2207786 | 2023C/550 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
| 1849470 | 17C1028 | France | ⤷ Try a Trial | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | LUC00036 | Luxembourg | ⤷ Try a Trial | 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 | 301257 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918 |
| 1849470 | 1790063-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
| 2207786 | 2023C/551 | Belgium | ⤷ Try a Trial | 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 |
| 2207786 | LUC00327 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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