Biologic facts
BrandNeupogen (Filgrastim)
5 filgrastim biosimilars from 5 makers are licensed. The 12-year reference exclusivity date of 02/2003 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Neupogen was first approved by the FDA in 1991; the application holder is Amgen Inc.
The latest NADAC for NEUPOGEN 300 MCG/0.5 ML SYR is $650.05 per mL (as of 10/28/2026).
Holder Amgen Inc.Approved 1991
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
- 02/200312-year estimate from first approval Purple Book
02Competition
- Biosimilars
- 5 biosimilars from 5 makers 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 Neupogen profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $650.05 per mLNEUPOGEN 300 MCG/0.5 ML SYR, as of 10/28/2026 CMS NADAC
- Latest recall
- 02/27/2025Class II, Filgrastim, Amgen, Inc. FDA enforcement
04Product
- Application holder
- Amgen Inc. Purple Book
- First approved
- 1991 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.