Biologic facts
BrandKesimpta (Ofatumumab)
No biosimilar to Kesimpta is licensed. The 12-year reference exclusivity date of 10/2021 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Kesimpta was first approved by the FDA in 2020; the application holder is Novartis Pharmaceuticals Corporation.
The latest NADAC for KESIMPTA 20 MG/0.4 ML PEN is $24,411.09 per mL (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorporationApproved 2020
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
- 10/202112-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 Kesimpta profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $24,411.09 per mLKESIMPTA 20 MG/0.4 ML PEN, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Novartis Pharmaceuticals Corporation Purple Book
- First approved
- 2020 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.