Orange Book product · Brand (NDA)

UCERIS

BUDESONIDE

Brand (NDA)NDA 203634TE ABRX SALIX

Jan 14, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 14, 2013
13 yr 7 mo ago
Today
Patent 10307375 expires
Listed drug product patent expiration.
Sep 07, 2031
in 5 yr 4 mo
Patent 10660858 expires
Listed drug product patent expiration.
Sep 07, 2031
in 5 yr 4 mo
Patent 8895064 expires
Listed drug product patent expiration.
Sep 07, 2031
in 5 yr 4 mo
Patent 9132093 expires
Listed drug product patent expiration.
Sep 07, 2031
in 5 yr 4 mo
Patent 9192581 expires
Listed drug product patent expiration.
Sep 07, 2031
in 5 yr 4 mo

Active ingredient

BUDESONIDE

Strength

9MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 203634

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10307375	Sep 07, 2031	in 5 yr 4 mo	Product
10660858	Sep 07, 2031	in 5 yr 4 mo	Product
8895064	Sep 07, 2031	in 5 yr 4 mo	Product
9132093	Sep 07, 2031	in 5 yr 4 mo	Product
9192581	Sep 07, 2031	in 5 yr 4 mo	ProductU-1325