ofatumumab (Arzerra)
ofatumumab is an FDA-licensed reference biologic from Novartis Pharmaceuticals Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Arzerra ofatumumab
Novartis Pharmaceuticals Corporation
- Approved
- Oct 26, 2009
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for ofatumumab from the RCSB Protein Data Bank (PDB 3GIZ).
Interactive biological assembly from PDB entry 3GIZ. 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 ofatumumab, in chronological order.
Reference approval
Approval date of the reference ofatumumab product.
16 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for ofatumumab (Arzerra)?
No 351(k) biosimilars or interchangeable biosimilars referencing ofatumumab 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.