daratumumab (Darzalex)
daratumumab is an FDA-licensed reference biologic from Janssen Biotech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Darzalex daratumumab
Janssen Biotech, Inc.
- Approved
- Nov 16, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for daratumumab from the RCSB Protein Data Bank (PDB 7DUN).
Interactive biological assembly from PDB entry 7DUN. 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 daratumumab, in chronological order.
Reference approval
Approval date of the reference daratumumab product.
10 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 mo
Frequently asked questions
Are there biosimilars approved for daratumumab (Darzalex)?
No 351(k) biosimilars or interchangeable biosimilars referencing daratumumab are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.