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Last Updated: September 25, 2022

VIBERZI Drug Patent 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 nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-two patent family members in forty 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.

DrugPatentWatch® 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 five 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.

There are two tentative approvals for the generic drug (eluxadoline), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for VIBERZI
Drug Prices for VIBERZI

See drug prices for VIBERZI

DrugPatentWatch® Estimated 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
University of North Carolina, Chapel HillPhase 2
AllerganPhase 2

See all VIBERZI clinical trials

Pharmacology for VIBERZI
Paragraph IV (Patent) Challenges for VIBERZI
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 VIBERZI

VIBERZI is protected by twenty US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIBERZI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VIBERZI

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl- -1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Opioid receptor modulator dosage formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds as opioid receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)

Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (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 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 206940-002 May 27, 2015 RX Yes Yes 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 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 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 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 VIBERZI

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 VIBERZI

When does loss-of-exclusivity occur for VIBERZI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14241076
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015022753
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06472
Estimated Expiration: See Plans and Pricing

China

Patent: 5228629
Estimated Expiration: See Plans and Pricing

Patent: 0917159
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20892
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68351
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1559
Estimated Expiration: See Plans and Pricing

Patent: 1591768
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68351
Estimated Expiration: See Plans and Pricing

Patent: 56321
Estimated Expiration: See Plans and Pricing

Patent: 65131
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 18514
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 42748
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1561
Estimated Expiration: See Plans and Pricing

Patent: 8718
Estimated Expiration: See Plans and Pricing

Japan

Patent: 49225
Estimated Expiration: See Plans and Pricing

Patent: 66975
Estimated Expiration: See Plans and Pricing

Patent: 16516694
Estimated Expiration: See Plans and Pricing

Patent: 19014744
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68351
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68351
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68351
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 150140681
Estimated Expiration: See Plans and Pricing

Spain

Patent: 93374
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 48071
Estimated Expiration: See Plans and Pricing

Patent: 1444590
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1815953
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIBERZI around the world.

Country Patent Number Title Estimated Expiration
Portugal 1725537 See Plans and Pricing
Hong Kong 1099016 NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS See Plans and Pricing
Montenegro 02540 Modulatori optoidnih receptora (Opioid receptor modulators) See Plans and Pricing
Japan 2019014744 オピオイド受容体モジュレーターの投与製剤 (DOSAGE FORMULATIONS OF OPIOID RECEPTOR MODULATOR) See Plans and Pricing
Japan 6449225 See Plans and Pricing
Denmark 2573068 See Plans and Pricing
Lithuania PA2017005 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIBERZI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 122017000009 Germany See Plans and Pricing PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919
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 10/2017 Austria See Plans and Pricing PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH ANNEHMBARES ENANTIOMER, DIASTEREOMER, RACEMAT ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 (MITTEILUNG) 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 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 683 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
McKinsey
Colorcon
Medtronic
Johnson and Johnson

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.