Orange Book product · Brand (NDA)

ARCAPTA NEOHALER

INDACATEROL MALEATE

Brand (NDA)NDA 022383DISCN NOVARTIS

Jul 01, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 01, 2011
15 yr 2 mo ago
Today
Patent 8479730 expires
Listed drug product patent expiration.
Oct 11, 2028
in 2 yr 4 mo

Active ingredient

INDACATEROL MALEATE

Strength

EQ 75MCG BASE

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 022383

Product number

001

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
8479730	Oct 11, 2028	in 2 yr 4 mo	Product