Biologic facts
BrandDupixent (Dupilumab)
No biosimilar to Dupixent is licensed. The 12-year reference exclusivity date of 03/2029 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Dupixent was first approved by the FDA in 2017; the application holder is Regeneron Pharmaceuticals, Inc.
The latest NADAC for DUPIXENT 300 MG/2 ML SYRINGE is $1,010.74 per mL (as of 10/28/2026).
Holder Regeneron Pharmaceuticals, Inc.Approved 2017
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
- 03/202912-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 Dupixent profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $1,010.74 per mLDUPIXENT 300 MG/2 ML SYRINGE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Regeneron Pharmaceuticals, Inc. Purple Book
- First approved
- 2017 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.