Aranesp (Darbepoetin Alpha)

No biosimilar to Aranesp is licensed. The 12-year reference exclusivity date of 09/2013 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Aranesp was first approved by the FDA in 2001; the application holder is Amgen Inc.

The latest NADAC for ARANESP 40 MCG/0.4 ML SYRINGE is $752.44 per mL (as of 10/28/2026).

Holder Amgen Inc.Approved 2001

Open full profile Start free trial

Data as of 10/30/2026

Reference exclusivityEndedEst. 09/2013; patents not in the Purple Book Biosimilars0 licensedNone licensed FDA shortageClearNot listedCurrent FDA list NADAC$752.44 / 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: 09/201312-year estimate from first approval

02Competition

Biosimilars: No biosimilar approved

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 Aranesp profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $752.44 per mLARANESP 40 MCG/0.4 ML SYRINGE, as of 10/28/2026

04Product

Application holder: Amgen Inc.
First approved: 2001

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