Details for New Drug Application (NDA): 202992

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NDA 202992 describes AUBAGIO, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AUBAGIO profile page.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

Summary for 202992

Tradename:	AUBAGIO
Applicant:	Sanofi Aventis Us
Ingredient:	teriflunomide
Patents:	3

Pharmacology for NDA: 202992

Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Suppliers and Packaging for NDA: 202992

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0210	58468-0210-1	1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK
AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0210	58468-0210-3	1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7MG
Approval Date:	Sep 12, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 30, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Apr 30, 2024
Regulatory Exclusivity Use:	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Patent:	6,794,410*PED	Patent Expiration:	Mar 12, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202992

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	5,459,163	⤷ Subscribe
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	5,459,163	⤷ Subscribe
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	5,679,709	⤷ Subscribe
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	5,679,709	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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