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Generated: November 17, 2018

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Details for New Drug Application (NDA): 210450

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NDA 210450 describes ORILISSA, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ORILISSA profile page.

The generic ingredient in ORILISSA is elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.
Summary for 210450
Tradename:ORILISSA
Applicant:Abbvie Inc
Ingredient:elagolix sodium
Patents:6
Generic Entry Opportunity Date for 210450
Generic Entry Date for 210450*:
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.

Suppliers and Packaging for NDA: 210450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORILISSA elagolix sodium TABLET;ORAL 210450 NDA AbbVie Inc. 0074-0038 0074-0038-01 1 BLISTER PACK in 1 CARTON (0074-0038-01) > 7 TABLET, FILM COATED in 1 BLISTER PACK
ORILISSA elagolix sodium TABLET;ORAL 210450 NDA AbbVie Inc. 0074-0038 0074-0038-07 1 BLISTER PACK in 1 CARTON (0074-0038-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jul 23, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 23, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 10, 2024Product Flag?YSubstance Flag?YDelist Request?

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