Remicade (Infliximab)

3 infliximab biosimilars from 3 makers are licensed. The 12-year reference exclusivity date of 08/2010 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Remicade was first approved by the FDA in 1998; the application holder is Janssen Biotech, Inc.

The latest NADAC for REMICADE 100 MG VIAL is $1,135.97 per unit (as of 03/11/2026).

Holder Janssen Biotech, Inc.Approved 1998

Open full profile Start free trial

Data as of 10/30/2026

Reference exclusivityEndedEst. 08/2010; patents not in the Purple Book Biosimilars3 licensedNone interchangeable FDA shortageClearNot listedCurrent FDA list NADAC$1,135.97 / unitAs of 03/11/2026

01Exclusivity

When biosimilar competition can legally begin. The Purple Book lists reference exclusivity but not patents, which can protect a biologic longer.

Patents: Not listed in the Purple Book
Reference exclusivity: 08/201012-year estimate from first approval

02Competition

Biosimilars: 3 biosimilars from 3 makers

Every makerEach licensed product and biosimilar maker.

PrescribersWho prescribes it, from Medicare data.

Spend and safetyMedicare Part B spend and safety reports.

Available in the full Remicade profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $1,135.97 per unitREMICADE 100 MG VIAL, as of 03/11/2026

04Product

Application holder: Janssen Biotech, Inc.
First approved: 1998
Other brand names: Zymfentra

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