ELUXADOLINE - Generic Drug Details

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 Abbvie and is included in one NDA. There are twenty 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

International Patents:	152
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	9
Patent Applications:	214
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELUXADOLINE
What excipients (inactive ingredients) are in ELUXADOLINE?	ELUXADOLINE excipients list
DailyMed Link:	ELUXADOLINE at DailyMed

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

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 ELUXADOLINE

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

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

See all ELUXADOLINE clinical trials

Generic filers with tentative approvals for ELUXADOLINE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		75MG	TABLET;ORAL
		100MG	TABLET; 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

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

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

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

International Patents for ELUXADOLINE

Country	Patent Number	Title	Estimated Expiration
New Zealand	582420	NOVEL 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
Poland	2653465
World Intellectual Property Organization (WIPO)	2014159245
European Patent Office	2176234	NOUVEAUX CRISTAUX ET PROCÉDÉ DE FABRICATION D'ACIDE 5-({[2-AMINO-3-(4-CARBAMOYL-2,6-DIMÉTHYL-PHÉNYL)-PROPIONYL]-[1-(4-PHÉNYL-1H-IMIDAZOL-2-YL)-ÉTHYL]-AMINO}-MÉTHYL)-2-MÉTHOXY- BENZOÏQUE (NOVEL 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)
Cyprus	1114167
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)
Austria	E516274

Supplementary Protection Certificates for ELUXADOLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	C20170005 00225	Estonia		PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016
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
2176234	122017000010	Germany		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
2176234	132017000028056	Italy		PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
2176234	17C1005	France		PRODUCT NAME: ELUXADOLINE; REGISTRATION NO/DATE: EU/1/16/1126 20160921
2176234	SPC/GB17/019	United Kingdom		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
1725537	SPC/GB17/020	United Kingdom		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/16/1126/001-006 20160921