Biologic facts
BrandEnhertu (Fam-Trastuzumab Deruxtecan)
No biosimilar to Enhertu is licensed. The 12-year reference exclusivity date of 12/2031 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Enhertu was first approved by the FDA in 2019; the application holder is Daiichi Sankyo, Inc.
Holder Daiichi Sankyo, IncApproved 2019
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
- 12/203112-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 Enhertu profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Daiichi Sankyo, Inc Purple Book
- First approved
- 2019 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.