Drug facts

Molecule

Warfarin

Generics already compete: 6 makers on the market. 54 A-rated products from 6 makers substitute at the counter.

Coumadin was first approved by the FDA before 1982 under NDA 009218; the application holder is Bristol Myers Squibb Pharma Co. The Orange Book lists NDA 009218 as discontinued.

The latest NADAC for WARFARIN SODIUM 2.5 MG TABLET is $0.10 per unit (as of 10/28/2026).

Holder Bristol Myers Squibb Pharma CoApplication NDA 009218Approved 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 Coumadin patent listed in the Orange Book
Orange Book

02Competition

Generics
6 generic makers
Orange Book
First generic approved
08/17/1982
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 Warfarin profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.10 per unitWARFARIN SODIUM 2.5 MG TABLET, mid-priced of 9 strengths, as of 10/28/2026
CMS NADAC
Latest recall
02/15/2023Class II, Warfarin Sodium Tablets, Rising Pharmaceuticals
FDA enforcement

04Product

Application holder
Bristol Myers Squibb Pharma Co
Orange Book
Application
NDA 009218
Orange Book
First approved
before 1982
Orange Book
Dosage forms
tablet
Routes
oral
Other brand names
Jantoven
Status
NDA 009218 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.