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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211675

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NDA 211675 describes RINVOQ, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. Additional details are available on the RINVOQ profile page.

The generic ingredient in RINVOQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.
Summary for 211675
Tradename:RINVOQ
Applicant:Abbvie Inc
Ingredient:upadacitinib
Patents:0
Generic Entry Opportunity Date for 211675
Generic Entry Date for 211675*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
TABLET, EXTENDED RELEASE;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.

Suppliers and Packaging for NDA: 211675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675 NDA AbbVie Inc. 0074-2306 0074-2306-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-30)
RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675 NDA AbbVie Inc. 0074-2306 0074-2306-70 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-70)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Aug 16, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 16, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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