pembrolizumab (Keytruda)
pembrolizumab is an FDA-licensed reference biologic from MSD International Business GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Keytruda pembrolizumab
MSD International Business GmbH
- Approved
- Sep 04, 2014
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for pembrolizumab from the RCSB Protein Data Bank (PDB 5DK3).
Interactive biological assembly from PDB entry 5DK3. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pembrolizumab, in chronological order.
Reference approval
Approval date of the reference pembrolizumab product.
12 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 7 mo
Frequently asked questions
Are there biosimilars approved for pembrolizumab (Keytruda)?
No 351(k) biosimilars or interchangeable biosimilars referencing pembrolizumab are listed in the FDA Purple Book yet.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.