Biologic facts
BrandKeytruda (Pembrolizumab)
No biosimilar to Keytruda is licensed. The 12-year reference exclusivity date of 09/2026 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Keytruda was first approved by the FDA in 2014; the application holder is MSD International Business GMBH.
Holder MSD International Business GMBHApproved 2014
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
- 09/202612-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 Keytruda profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- MSD International Business GMBH Purple Book
- First approved
- 2014 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.