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Last Updated: June 19, 2021

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VIBERZI Drug Profile


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

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.

DrugPatentWatch® Generic Entry Outlook for Viberzi

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

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Drug patent expirations by year for VIBERZI
Drug Prices for VIBERZI

See drug prices for VIBERZI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VIBERZI
Generic Entry Date for VIBERZI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 VIBERZI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Temple UniversityPhase 2/Phase 3
University of North Carolina, Chapel HillPhase 2
AllerganPhase 2

See all VIBERZI clinical trials

Pharmacology for VIBERZI
Paragraph IV (Patent) Challenges for VIBERZI
Tradename Dosage Ingredient NDA Submissiondate
VIBERZI TABLET;ORAL eluxadoline 206940 2019-05-28

US Patents and Regulatory Information for VIBERZI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VIBERZI

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

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Serving leading biopharmaceutical companies globally:

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