Novolog (Insulin Aspart)

3 insulin aspart biosimilars from 3 makers are licensed, 2 of them interchangeable. The 12-year reference exclusivity date of 06/2012 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Novolog was first approved by the FDA in 2000; the application holder is Novo Nordisk Inc.

The latest NADAC for NOVOLOG PENFILL 100 UNIT/ML is $8.57 per mL (as of 10/28/2026).

Holder Novo Nordisk Inc.Approved 2000

Open full profile Start free trial

Data as of 10/29/2026

Reference exclusivityEndedEst. 06/2012; patents not in the Purple Book Biosimilars3 licensed2 interchangeable FDA shortageClearNot listedCurrent FDA list NADAC$8.57 / mLMid-priced of 3 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: 06/201212-year estimate from first approval

02Competition

Biosimilars: 3 biosimilars from 3 makers
Interchangeable: 2

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 Novolog profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $8.57 per mLNOVOLOG PENFILL 100 UNIT/ML, mid-priced of 3 strengths, as of 10/28/2026

04Product

Application holder: Novo Nordisk Inc.
First approved: 2000
Other brand names: Fiasp

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