Details for New Drug Application (NDA): 206940

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NDA 206940 describes VIBERZI, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug. Additional details are available on the VIBERZI profile page.

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.

Summary for 206940

Tradename:	VIBERZI
Applicant:	Abbvie
Ingredient:	eluxadoline
Patents:	21

Pharmacology for NDA: 206940

Mechanism of Action	Opioid mu-Receptor Agonists

Suppliers and Packaging for NDA: 206940

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075	61874-075-08	1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK
VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075	61874-075-60	1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	May 27, 2015	TE:	AB	RLD:	Yes
Patent:	10,188,632	Patent Expiration:	Mar 14, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,213,415	Patent Expiration:	Mar 14, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)
Patent:	11,007,179	Patent Expiration:	Mar 14, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 206940

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	9,205,076	⤷ Try for Free
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,772,325	⤷ Try for Free
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	10,213,415	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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