Drug facts

Molecule

Furosemide (Lasix Onyu)

Generics already compete: 20 makers on the market. 30 A-rated products from 20 makers substitute at the counter.

Lasix was first approved by the FDA before 1982 under NDA 016273; the application holder is Validus Pharmaceuticals LLC. The Orange Book lists NDA 016273 as discontinued.

Furosemide is on the current FDA drug shortage list, first posted 04/07/2020.

Holder Validus Pharmaceuticals LLCApplication NDA 016273Approved before 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 Lasix patent listed in the Orange Book
Orange Book
Later patents, other products
Lasix Onyu 01/10/2042; Furoscix 01/30/2040
Orange Book

02Competition

Generics
20 generic makers
Orange Book
First generic approved
09/09/1985
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 Furosemide profile.See what is included

03Supply and price

FDA drug shortage
ActiveOn the current shortage listsince 04/07/2020, available
FDA shortages
NADAC
$0.26 per mLFUROSEMIDE 40 MG/4 ML VIAL, mid-priced of 4 strengths, as of 10/28/2026
CMS NADAC
Latest recall
03/20/2026Class II, Furosemide, Leading Pharma, LLC
FDA enforcement

04Product

Application holder
Validus Pharmaceuticals LLC
Orange Book
Application
NDA 016273
Orange Book
First approved
before 1982
Orange Book
Dosage forms
injectable; solution; tablet
Routes
injection, oral, subcutaneous
Other brand names
Furoscix
Status
NDA 016273 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.