dupilumab (Dupixent)
dupilumab is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Dupixent dupilumab
Regeneron Pharmaceuticals, Inc.
- Approved
- Jun 18, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for dupilumab from the RCSB Protein Data Bank (PDB 6WG8).
Interactive biological assembly from PDB entry 6WG8. 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 dupilumab, in chronological order.
Reference approval
Approval date of the reference dupilumab product.
6 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 9 mo
Frequently asked questions
Are there biosimilars approved for dupilumab (Dupixent)?
No 351(k) biosimilars or interchangeable biosimilars referencing dupilumab 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.