Humira (Adalimumab)

10 adalimumab biosimilars from 10 makers are licensed, 9 of them interchangeable. The 12-year reference exclusivity date of 12/2014 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Humira was first approved by the FDA in 2002; the application holder is Abbvie Inc.

The latest NADAC for HUMIRA(CF) 40 MG/0.4 ML SYRINGE is $3,368.44 per unit (as of 10/28/2026).

Holder Abbvie Inc.Approved 2002

Open full profile Start free trial

Data as of 10/30/2026

Reference exclusivityEndedEst. 12/2014; patents not in the Purple Book Biosimilars10 licensed9 interchangeable FDA shortageClearNot listedCurrent FDA list NADAC$3,368.44 / unitMid-priced of 7 strengths

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: 12/201412-year estimate from first approval

02Competition

Biosimilars: 10 biosimilars from 10 makers
Interchangeable: 9

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 Humira profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $3,368.44 per unitHUMIRA(CF) 40 MG/0.4 ML SYRINGE, mid-priced of 7 strengths, as of 10/28/2026

04Product

Application holder: Abbvie Inc.
First approved: 2002

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