Stelara (Ustekinumab)

8 ustekinumab biosimilars from 8 makers are licensed, 8 of them interchangeable. The 12-year reference exclusivity date of 09/2021 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Stelara was first approved by the FDA in 2009; the application holder is Janssen Biotech, Inc.

The latest NADAC for STELARA 90 MG/ML SYRINGE is $29,792.79 per mL (as of 10/28/2026).

Holder Janssen Biotech, Inc.Approved 2009

Open full profile Start free trial

Data as of 10/30/2026

Reference exclusivityEndedEst. 09/2021; patents not in the Purple Book Biosimilars8 licensed8 interchangeable FDA shortageClearNot listedCurrent FDA list NADAC$29,792.79 / mLAs of 10/28/2026

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: 09/202112-year estimate from first approval

02Competition

Biosimilars: 8 biosimilars from 8 makers
Interchangeable: 8

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 Stelara profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $29,792.79 per mLSTELARA 90 MG/ML SYRINGE, as of 10/28/2026

04Product

Application holder: Janssen Biotech, Inc.
First approved: 2009

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