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Last Updated: February 23, 2024

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 Abbvie and is included in one NDA. There are twenty 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 seven 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 Loss of Exclusivity (LOE) 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-one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIBERZI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF THE FREQUENCY OF ABDOMINAL PAIN AND DIARRHEA, IN AN INFLAMMATORY BOWEL DISEASE WITH DIARRHEA (IBS-D) PATIENT, WITH ELUXADOLINE TWICE DAILY WITH FOOD

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

Opioid receptor modulator dosage formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds as opioid receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 2015022753
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 06472
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5228629
Estimated Expiration: ⤷  Try a Trial

Patent: 0917159
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20892
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68351
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1559
Estimated Expiration: ⤷  Try a Trial

Patent: 1591768
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68351
Estimated Expiration: ⤷  Try a Trial

Patent: 56321
Estimated Expiration: ⤷  Try a Trial

Patent: 65131
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 18514
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 42748
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1561
Estimated Expiration: ⤷  Try a Trial

Patent: 8718
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 49225
Estimated Expiration: ⤷  Try a Trial

Patent: 66975
Estimated Expiration: ⤷  Try a Trial

Patent: 16516694
Estimated Expiration: ⤷  Try a Trial

Patent: 19014744
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68351
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68351
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68351
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2435440
Estimated Expiration: ⤷  Try a Trial

Patent: 150140681
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 93374
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 48071
Estimated Expiration: ⤷  Try a Trial

Patent: 1444590
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1815953
Estimated Expiration: ⤷  Try a Trial

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
Slovenia 2968351 ⤷  Try a Trial
Japan 2016128433 5−({[2−アミノ−3−(4−カルバモイル−2,6−ジメチル−フェニル)−プロピオニル]−[1−(4−フェニル−1H−イミダゾール−2−イル)−エチル]−アミノ}−メチル)−2−メトキシ−安息香酸の新規な結晶及び製造方法 (NEW CRYSTALS AND METHODS 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) ⤷  Try a Trial
Ecuador SP066856 COMPUESTOS NOVEDOSOS COMO MODULADORES DEL RECEPTOR OPIOIDE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIBERZI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176234 122017000010 Germany ⤷  Try a Trial PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
2176234 SPC/GB17/019 United Kingdom ⤷  Try a Trial PRODUCT NAME: ELUXADOLINE; REGISTERED: UK EU/1/16/1126/001(NI) 20160921; UK EU/1/16/1126/002(NI) 20160921; UK EU/1/16/1126/003(NI) 20160921; UK EU/1/16/1126/004(NI) 20160921; UK PLGB 45496/0015 20160921
2176234 132017000028056 Italy ⤷  Try a Trial PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
>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.