Orange Book product · Brand (NDA)

ULORIC

FEBUXOSTAT

Brand (NDA)NDA 021856TE ABRX TAKEDA PHARMS USA

Feb 13, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 13, 2009
17 yr 7 mo ago
Today
Patent 8372872 expires
Listed method-of-use patent (U-1346) expiration.
Sep 08, 2031
in 5 yr 4 mo
Patent 9107912 expires
Listed method-of-use patent (U-1346) expiration.
Sep 08, 2031
in 5 yr 4 mo

Active ingredient

FEBUXOSTAT

Strength

40MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021856

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
8372872	Sep 08, 2031	in 5 yr 4 mo	U-1346
9107912	Sep 08, 2031	in 5 yr 4 mo	U-1346