Orange Book product · Brand (NDA)

ORTIKOS

BUDESONIDE

Brand (NDA)NDA 211929DISCN SUN PHARM INDS INC

Jun 13, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 13, 2019
7 yr 1 mo ago
Today
Patent 10172802 expires
Listed method-of-use patent (U-2554) expiration.
Sep 09, 2036
in 10 yr 5 mo
Patent 9707182 expires
Listed drug product patent expiration.
Sep 09, 2036
in 10 yr 5 mo

Active ingredient

BUDESONIDE

Strength

9MG

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 211929

Product number

002

Marketing status

DISCN

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
10172802	Sep 09, 2036	in 10 yr 5 mo	U-2554
9707182	Sep 09, 2036	in 10 yr 5 mo	ProductU-2554