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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206940

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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 twelve patents protecting this drug. Additional details are available on the VIBERZI profile page.

The generic ingredient in VIBERZI is eluxadoline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
Summary for 206940
Applicant:Allergan Holdings
Generic Entry Opportunity Date for 206940
Generic Entry Date for 206940*:
Constraining patent/regulatory exclusivity:

*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

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:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Mar 25, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Mar 14, 2025Product Flag?Substance Flag?YDelist Request?

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