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Last Updated: September 16, 2021

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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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for eluxadoline
Recent Clinical Trials for eluxadoline

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

SponsorPhase
AllerganPhase 3
Temple UniversityPhase 2/Phase 3
University of North Carolina, Chapel HillPhase 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 206940-001 May 27, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 C 2017 006 Romania ⤷  Free Forever Trial 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
2176234 122017000010 Germany ⤷  Free Forever Trial PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 309 6-2017 Slovakia ⤷  Free Forever Trial PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
2176234 132017000028056 Italy ⤷  Free Forever Trial PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
1725537 CR 2017 00008 Denmark ⤷  Free Forever Trial PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921
1725537 PA2017005,C1725537 Lithuania ⤷  Free Forever Trial PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 122017000009 Germany ⤷  Free Forever Trial PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; 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:

McKinsey
Harvard Business School
Baxter
Johnson and Johnson
Colorcon
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.