Biologic facts

Brand

Repatha (Evolocumab)

No biosimilar to Repatha is licensed. The 12-year reference exclusivity date of 08/2027 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Repatha was first approved by the FDA in 2015; the application holder is Amgen Inc.

The latest NADAC for REPATHA 140 MG/ML SURECLICK is $282.01 per mL (as of 10/28/2026).

Holder Amgen Inc.Approved 2015

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
Purple Book
Reference exclusivity
08/202712-year estimate from first approval
Purple Book

02Competition

Biosimilars
No biosimilar approved
Purple Book
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 Repatha profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$282.01 per mLREPATHA 140 MG/ML SURECLICK, as of 10/28/2026
CMS NADAC

04Product

Application holder
Amgen Inc.
Purple Book
First approved
2015
Purple Book

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