Orange Book product · Brand (NDA)

AUBAGIO

TERIFLUNOMIDE

Brand (NDA)NDA 202992TE ABRX SANOFI AVENTIS US

Sep 12, 2012

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 12, 2012
14 yr ago
Today
Patent 6794410 expires
Listed method-of-use patent (U-1285) expiration.
Sep 12, 2026
in 3 mo
Patent 6794410*PED expires
Listed listed patent expiration.
Mar 12, 2027
in 9 mo
Patent 8802735 expires
Listed drug product patent expiration.
Sep 14, 2030
in 4 yr 4 mo
Patent 8802735*PED expires
Listed listed patent expiration.
Mar 14, 2031
in 4 yr 10 mo
Patent 9186346 expires
Listed method-of-use patent (U-1786) expiration.
Feb 04, 2034
in 7 yr 9 mo
Patent 9186346*PED expires
Listed listed patent expiration.
Aug 04, 2034
in 8 yr 3 mo

Active ingredient

TERIFLUNOMIDE

Strength

7MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 202992

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6794410	Sep 12, 2026	in 3 mo	U-1285
6794410*PED	Mar 12, 2027	in 9 mo
8802735	Sep 14, 2030	in 4 yr 4 mo	Product
8802735*PED	Mar 14, 2031	in 4 yr 10 mo
9186346	Feb 04, 2034	in 7 yr 9 mo	U-1786
9186346*PED	Aug 04, 2034	in 8 yr 3 mo