Drug facts

Molecule

Fluticasone and Salmeterol (Advair HFA)

Generics already compete: 5 makers on the market. 14 A-rated products from 5 makers substitute at the counter.

Advair Diskus 100/50 was first approved by the FDA on 08/24/2000 under NDA 021077; the application holder is Glaxo Group Ltd England Dba Glaxosmithkline.

The latest NADAC for FLUTICASONE-SALMETEROL 500-50 is $1.62 per unit (as of 10/28/2026).

Holder Glaxo Group Ltd England Dba GlaxosmithklineApplication NDA 021077Approved 08/24/2000

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent
No Advair Diskus 100/50 patent listed in the Orange Book
Orange Book
Later patents, other products
Airduo Digihaler 01/06/2041
Orange Book

02Competition

Generics
5 generic makers
Orange Book
First generic approved
01/30/2019
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Fluticasone and Salmeterol profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$1.62 per unitFLUTICASONE-SALMETEROL 500-50, mid-priced of 6 strengths, as of 10/28/2026
CMS NADAC
Latest recall
01/26/2022Class II, Fluticasone Propionate and Salmeterol, Cardinal Healthcare
FDA enforcement

04Product

Application holder
Glaxo Group Ltd England Dba Glaxosmithkline
Orange Book
Application
NDA 021077
Orange Book
First approved
08/24/2000
Orange Book
Dosage forms
aerosol, metered; powder
Routes
inhalation
Other brand names
Advair Diskus 100/50Advair Diskus 250/50Advair Diskus 500/50Airduo RespiclickWixela Inhub

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.