Biologic facts
BrandProlia (Denosumab)
20 denosumab biosimilars from 10 makers are licensed, 20 of them interchangeable. The 12-year reference exclusivity date of 06/2022 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Prolia was first approved by the FDA in 2010; the application holder is Amgen Inc.
The latest NADAC for PROLIA 60 MG/ML SYRINGE is $1,863.22 per mL (as of 10/28/2026).
Holder Amgen Inc.Approved 2010
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
- 06/202212-year estimate from first approval Purple Book
02Competition
- Biosimilars
- 20 biosimilars from 10 makers Purple Book
- Interchangeable
- 20 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 Prolia profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $1,863.22 per mLPROLIA 60 MG/ML SYRINGE, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/21/2025Class II, Denosumab, Mckesson Medical-Surgical Inc. Corporate Office FDA enforcement
04Product
- Application holder
- Amgen Inc. Purple Book
- First approved
- 2010 Purple Book
- Other brand names
- Xgeva
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.