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Last Updated: August 14, 2020

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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.

This drug has one hundred and forty-seven patent family members in thirty-nine 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.

US ANDA Litigation and 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 two 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

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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
AllerganPhase 2
University of North Carolina, Chapel HillPhase 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   Start Trial   Start Trial   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>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   Start Trial 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 122017000010 Germany   Start Trial PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 300865 Netherlands   Start Trial PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER,DIASTEREOMEER, RACEMAAT OF ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1126 20160921
2176234 17C1005 France   Start Trial PRODUCT NAME: ELUXADOLINE; REGISTRATION NO/DATE: EU/1/16/1126 20160921
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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