Orange Book product · Brand (NDA)

INCRUSE ELLIPTA

UMECLIDINIUM BROMIDE

Brand (NDA)NDA 205382RX GLAXO GRP ENGLAND

Apr 30, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 30, 2014
12 yr 4 mo ago
Today
Patent 7488827 expires
Listed drug substance patent expiration.
Dec 18, 2027
in 1 yr 6 mo

Active ingredient

UMECLIDINIUM BROMIDE

Strength

EQ 0.0625MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 205382

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
7488827	Dec 18, 2027	in 1 yr 6 mo	SubstanceProduct