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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206940

Generic Entry Date for 206940^: ⤷ Try for Free* Constraining patent/regulatory exclusivity: ⤷ Try for Free 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.

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:		RLD:	Yes
Patent:	⤷ Try for Free	Patent Expiration:	Mar 14, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try for Free	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:	⤷ Try for Free	Patent Expiration:	Mar 14, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 206940

Show entries

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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	⤷ Try for Free	⤷ Try for Free
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	⤷ Try for Free	⤷ Try for Free
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	⤷ Try for Free	⤷ Try for Free
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Showing 1 to 4 of 4 entries

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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.