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VIBERZI Drug Patent Profile

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-one 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

Summary for VIBERZI

International Patents:	152
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2
Patent Applications:	100
Drug Prices:	Drug price information for VIBERZI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIBERZI
What excipients (inactive ingredients) are in VIBERZI?	VIBERZI excipients list
DailyMed Link:	VIBERZI at DailyMed

See drug prices for VIBERZI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIBERZI

NDA:

206940

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

Sponsor	Phase
Temple University	Phase 2/Phase 3
Allergan	Phase 2
University of North Carolina, Chapel Hill	Phase 2

See all VIBERZI clinical trials

Pharmacology for VIBERZI

Drug Class	mu-Opioid Receptor Agonist
Mechanism of Action	Opioid mu-Receptor Agonists

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-two US patents.

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

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			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes				Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No			Y	Y

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

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

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

Turkey

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
Mexico	339569	NUEVOS CRISTALES Y PROCESOS PARA ELABORAR 5-({[2-AMINO-3-(4-CARBAM OIL-2,6-DIMETILFENIL)-PROPIONIL]-[1-(4-FENIL-1H-IMIDAZOL-2-IL)-ET IL]-AMINO}-METIL)-2-ACIDO METOXIBENZOICO. (NOVEL CRYSTALS AND PROCESS OF MAKING 5-({[2-AMINO-3-(4-CARBAMOYL- 2,6-DIMETHYL-PHENYL)-PROPIONYL]-[1-(4-PHENYL-1H-IMIDAZOL-2-YL)-E THYL]-AMINO}-METHYL)-2-METHOXY- BENZOIC ACID.)
Denmark	3112352
Portugal	2573068
Japan	2018123144	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 (NOVEL CRYSTALS AND PRODUCTION PROCESSES 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)
Poland	1725537
Philippines	12012501640	NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS

Supplementary Protection Certificates for VIBERZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	CR 2017 00008	Denmark		PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921
1725537	132017000028006	Italy		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	2017C/003	Belgium		PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER, DIASTEREOMEER, RACEMAAT OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU1/16/1126 20160921
1725537	LUC00007	Luxembourg		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	C20170005 00225	Estonia		PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016
1725537	CA 2017 00008	Denmark		PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921