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Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-nine patent family members in forty countries.
The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
Viberzi was eligible for patent challenges on May 27, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2033. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for VIBERZI
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||28|
|Drug Prices:||Drug price information for VIBERZI|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for VIBERZI|
|What excipients (inactive ingredients) are in VIBERZI?||VIBERZI excipients list|
|DailyMed Link:||VIBERZI at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VIBERZI
*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 VIBERZI
Identify potential brand extensions & 505(b)(2) entrants
|Temple University||Phase 2/Phase 3|
|University of North Carolina, Chapel Hill||Phase 2|
Pharmacology for VIBERZI
|Country||Patent Number||Estimated Expiration|
|South Korea||20100043210||Get Started Free|
|Hong Kong||1105967||Get Started Free|
|Hong Kong||1155726||Get Started Free|
|Serbia||55122||Get Started Free|
|European Patent Office||3456321||Get Started Free|
|Spain||2533176||Get Started Free|
|Hong Kong||1184432||Get Started Free|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1725537||132017000028006||Italy||Get Started Free||PRODUCT NAME: ELUXADOLINE O UN ENANTIOMERO, DIASTEREOMERO, RACEMATO FARMACEUTICAMENTE ACCETTABILE O SALI DELLO STESSO(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921|
|2176234||132017000028056||Italy||Get Started Free||PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921|
|1725537||C 2017 006||Romania||Get Started Free||PRODUCT NAME: ELUXADOLINA SAU UN ENANTIOMER, UN DIASTEREOMER, UN RACEMAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1126; DATE OF NATIONAL AUTHORISATION: 20160919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1126; DATE OF FIRST AUTHORISATION IN EEA: 20160919|
|1725537||309 6-2017||Slovakia||Get Started Free||PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921|
|1725537||122017000009||Germany||Get Started Free||PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919|
|1725537||17C1006||France||Get Started Free||PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/16/1126 20160921|
|1725537||2017/007||Ireland||Get Started Free||PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|