➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Johnson and Johnson
McKinsey
Baxter
McKesson

Last Updated: January 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206940

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 206940 describes VIBERZI, which is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are fourteen 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:Allergan Holdings
Ingredient:eluxadoline
Patents:14
Generic Entry Opportunity Date for 206940
Generic Entry Date for 206940*:
Constraining patent/regulatory exclusivity:
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 ActionOpioid 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 61874-075-60 60 CARTON in 1 BOTTLE (61874-075-60) > 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. 61874-100 61874-100-60 60 CARTON in 1 BOTTLE (61874-100-60) > 1 BLISTER PACK in 1 CARTON (61874-100-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 206940
Tradename Dosage Ingredient NDA Submissiondate
VIBERZI TABLET;ORAL eluxadoline 206940 2019-05-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:May 27, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2020
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Mar 14, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 14, 2025Product Flag?Substance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Johnson and Johnson
McKinsey
Medtronic
Boehringer Ingelheim

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.