Drug facts

Molecule

Fluticasone

Generics already compete: 10 makers on the market. 12 A-rated products from 9 makers substitute at the counter.

Cutivate was first approved by the FDA on 12/14/1990 under NDA 019957; the application holder is Fougera Pharmaceuticals LLC. The Orange Book lists NDA 019957 as discontinued.

The latest NADAC for FLUTICASONE PROPIONATE HFA 110 MCG INHALER is $13.56 per gram (as of 10/28/2026).

Holder Fougera Pharmaceuticals LLCApplication NDA 019957Approved 12/14/1990

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 Cutivate patent listed in the Orange Book
Orange Book
Later patents, other products
Armonair Digihaler 01/06/2041; Xhance 02/23/2036
Orange Book

02Competition

Generics
10 generic makers
Orange Book
First generic approved
05/14/2004
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 profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$13.56 per gramFLUTICASONE PROPIONATE HFA 110 MCG INHALER, mid-priced of 3 strengths, as of 10/28/2026
CMS NADAC
Latest recall
02/14/2024Class II, Fluticasone Propionate Nasal Spray USP, Golden State Medical Supply Inc.
FDA enforcement

04Product

Application holder
Fougera Pharmaceuticals LLC
Orange Book
Application
NDA 019957
Orange Book
First approved
12/14/1990
Orange Book
Dosage forms
aerosol, metered; cream; lotion; ointment; powder; spray, metered
Routes
inhalation, nasal, topical
Other brand names
Flonase Allergy ReliefFlovent Diskus 100Flovent Diskus 250Flovent Diskus 50Flovent HFAXhance
Status
NDA 019957 discontinued
Orange Book

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