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Last Updated: September 29, 2020

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Eluxadoline - Generic Drug Details

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What are the generic drug sources for eluxadoline and what is the scope of patent protection?

Eluxadoline is the generic ingredient in one branded drug marketed by Allergan Holdings and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eluxadoline has one hundred and forty-eight patent family members in thirty-nine countries.

There are two drug master file entries for eluxadoline. One supplier is listed for this compound.

Recent Clinical Trials for eluxadoline

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 eluxadoline clinical trials

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

US Patents and Regulatory Information for eluxadoline

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 Y   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Start Trial   Start Trial 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
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No   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
>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 eluxadoline

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725537 LUC00007 Luxembourg   Start Trial PRODUCT NAME: ELUXADOLINE OU UN ENANTIOMERE, UN DIASTEREOMERE, UNRACEMATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/16/1126 20160921
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
1725537 C20170005 00225 Estonia   Start Trial PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016
1725537 PA2017005,C1725537 Lithuania   Start Trial PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 CA 2017 00008 Denmark   Start Trial PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921
2176234 17C1005 France   Start Trial PRODUCT NAME: ELUXADOLINE; REGISTRATION 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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