Drug facts

Molecule

Albuterol (Ventolin HFA)

Generics already compete: 23 makers on the market. 37 A-rated products from 23 makers substitute at the counter.

Proventil was first approved by the FDA on 05/07/1982 under NDA 017853; the application holder is Schering Corp Sub Schering Plough Corp. The Orange Book lists NDA 017853 as discontinued.

The latest NADAC for ALBUTEROL SULFATE 2 MG TAB is $0.31 per unit (as of 10/28/2026).

Holder Schering Corp Sub Schering Plough CorpApplication NDA 017853Approved 05/07/1982

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 Proventil patent listed in the Orange Book
Orange Book

02Competition

Generics
23 generic makers
Orange Book
First generic approved
12/05/1989
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 Albuterol profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.31 per unitALBUTEROL SULFATE 2 MG TAB, as of 10/28/2026
CMS NADAC
Latest recall
03/17/2026Class II, Albuterol Sulfate Inhalation Solution, Nephron Sc, LLC
FDA enforcement

04Product

Application holder
Schering Corp Sub Schering Plough Corp
Orange Book
Application
NDA 017853
Orange Book
First approved
05/07/1982
Orange Book
Dosage forms
aerosol, metered; powder, metered; solution; syrup; tablet
Routes
inhalation, oral
Other brand names
Proair HFAProair RespiclickProventil-HFA
Status
NDA 017853 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.