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Eluxadoline - Generic Drug Details

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

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

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

Summary for eluxadoline

International Patents:	149
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	6
Patent Applications:	162
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

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

Pharmacology for eluxadoline

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

Anatomical Therapeutic Chemical (ATC) Classes for eluxadoline

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ELUXADOLINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIBERZI	TABLET;ORAL	eluxadoline	206940	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				Y
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No				Y
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y	Y
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No			Y	Y
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y
Allergan Holdings	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes

International Patents for eluxadoline

Country	Patent Number	Estimated Expiration
Israel	268718
South Africa	201000921
Mexico	339569
Hungary	S1700010
Argentina	048269
Montenegro	02221
Ecuador	SP066856

Supplementary Protection Certificates for eluxadoline

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	C 2017 006	Romania		PRODUCT NAME: ELUXADOLINA SAU UN ENANTIOMER, UN DIASTEREOMER, UN RACEMAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1126; DATE OF NATIONAL AUTHORISATION: 20160919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1126; DATE OF FIRST AUTHORISATION IN EEA: 20160919
2176234	122017000010	Germany		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	309 6-2017	Slovakia		PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
2176234	132017000028056	Italy		PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
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	PA2017005,C1725537	Lithuania		PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	122017000009	Germany		PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919