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Last Updated: December 2, 2022

Eluxadoline - Generic Drug Details


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What are the generic 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 nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Generic filers with tentative approvals for ELUXADOLINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing75MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for eluxadoline
Paragraph IV (Patent) Challenges for ELUXADOLINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIBERZI Tablets eluxadoline 75 mg and 100 mg 206940 6 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan Holdings VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for eluxadoline

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Allergan Pharmaceuticals International Limited Truberzi eluxadoline EMEA/H/C/004098
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).
Withdrawn no no no 2016-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for eluxadoline

Country Patent Number Title Estimated Expiration
European Patent Office 1725537 NOUVEAUX COMPOSES EN TANT QUE MODULATEURS DE RECEPTEURS D'OPIOIDES (NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS) See Plans and Pricing
European Patent Office 2968351 FORMULATIONS PHARMACEUTIQUES DE MODULATEUR DES RÉCEPTEURS AUX OPIOÏDES (OPIOID RECEPTOR MODULATOR DOSAGE FORMULATIONS) See Plans and Pricing
Hong Kong 1099016 NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS See Plans and Pricing
Portugal 2298744 See Plans and Pricing
European Patent Office 3456321 FORMULATIONS DE DOSAGE DE MODULATEUR DU RÉCEPTEUR OPIOÏDE (OPIOID RECEPTOR MODULATOR DOSAGE FORMULATIONS) See Plans and Pricing
Spain 2705077 See Plans and Pricing
Ecuador SP066856 COMPUESTOS NOVEDOSOS COMO MODULADORES DEL RECEPTOR OPIOIDE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eluxadoline

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725537 2017/007 Ireland See Plans and Pricing PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 132017000028006 Italy See Plans and Pricing 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 309 6-2017 Slovakia See Plans and Pricing PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537 122017000009 Germany See Plans and Pricing PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 683 Finland See Plans and Pricing
1725537 PA2017005,C1725537 Lithuania See Plans and Pricing PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537 PA2017005 Lithuania See Plans and Pricing PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; 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:

McKesson
Merck
Medtronic
Moodys
Boehringer Ingelheim
McKinsey

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