Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

VIBERZI Drug Profile

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Which patents cover Viberzi, and when can generic versions of Viberzi launch?

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 patent family members in thirty-eight 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.

Drug patent expirations by year for VIBERZI
Drug Prices for VIBERZI

See drug prices for VIBERZI

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
AllerganPhase 2
University of North Carolina, Chapel HillPhase 2

See all VIBERZI clinical trials

Recent Litigation for VIBERZI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Lee2015-01-14
Novartis AG v. Lee2013-01-14
Allergan USA, Inc. v. Aurobindo Pharma Ltd.

See all VIBERZI litigation

Pharmacology for VIBERZI
Synonyms for VIBERZI
45TPJ4MBQ1
5-(((S)-2-AMINO-3-(4-CARBAMOYL-2,6-DIMETHYLPHENYL)-N-((S)-1-(4-PHENYL-1H-IMIDAZOL-2-YL)ETHYL)PROPANAMIDO)METHYL)-2-METHOXYBENZOIC ACID
5-(((S)-2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)-N-((S)-1-(5-phenyl-1H-imidazol-2-yl)ethyl)propanamido)methyl)-2-methoxybenzoic acid
5-({(4-carbamoyl-2,6-dimethyl-L-phenylalanyl)[(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid
5-[[[(2S)-2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)propanoyl]-[(1S)-1-(4-phenyl-3H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid
864821-90-9
AC-30329
AKOS030632800
AS-35135
Benzoic acid, 5-((((2S)-2-amino-3-(4-(aminocarbonyl)-2,6-dimethylphenyl)-1-oxopropyl)((1S)-1-(5-phenyl-1H-imidazol-2-yl)ethyl)amino)methyl)-2-methoxy-
CHEBI:85980
CHEMBL2159122
CS-3855
D10403
DB09272
DEA No. 9725
DTXSID70235589
Eluxadoline
Eluxadoline (USAN)
Eluxadoline [USAN:INN]
EX-A1169
FT-0701295
GTPL7691
HY-12247
J3.535.064K
JNJ 27018966
JNJ-27018966
JNJ27018966
NCGC00485958-01
SB17335
SCHEMBL12971682
SCHEMBL17950908
truberzi
UNII-45TPJ4MBQ1
Viberzi (TN)
ZINC14210876
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   Start Trial
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 206940-001 May 27, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes   Start Trial   Start Trial 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 2017/007 Ireland   Start Trial PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 122017000009 Germany   Start Trial PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES ENANTIOMER, DIASTEREOMER, RACEMATE ODER SALZ DAVON; 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
1725537 1790007-7 Sweden   Start Trial PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REG. NO/DATE: EU/1/16/1126 20160921
1725537 17C1006 France   Start Trial PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/16/1126 20160921
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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