Enbrel (Etanercept)

No biosimilar to Enbrel is marketed; 2 licensed etanercept biosimilars are listed as discontinued in the Purple Book. The 12-year reference exclusivity date of 11/2010 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Enbrel was first approved by the FDA in 1998; the application holder is Immunex Corporation.

The latest NADAC for ENBREL 50 MG/ML MINI CARTRIDGE is $2,081.68 per mL (as of 10/28/2026).

Holder Immunex CorporationApproved 1998

Open full profile Start free trial

Data as of 10/30/2026

Reference exclusivityEndedEst. 11/2010; patents not in the Purple Book Biosimilars0 marketed2 licensed, discontinued FDA shortageClearNot listedCurrent FDA list NADAC$2,081.68 / 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: 11/201012-year estimate from first approval

02Competition

Biosimilars: No biosimilar marketed (2 licensed, discontinued)

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 Enbrel profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $2,081.68 per mLENBREL 50 MG/ML MINI CARTRIDGE, as of 10/28/2026

04Product

Application holder: Immunex Corporation
First approved: 1998

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