obinutuzumab (Gazyva)
obinutuzumab is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2013
Reference approved
Reference product
Gazyva obinutuzumab
Genentech, Inc.
- Approved
- Nov 01, 2013
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for obinutuzumab from the RCSB Protein Data Bank (PDB 6Y97).
Interactive biological assembly from PDB entry 6Y97. 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 obinutuzumab, in chronological order.
Reference approval
Approval date of the reference obinutuzumab product.
12 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for obinutuzumab (Gazyva)?
No 351(k) biosimilars or interchangeable biosimilars referencing obinutuzumab 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.