rituximab and hyaluronidase human (Rituxan Hycela)
rituximab and hyaluronidase human 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
2017
Reference approved
Reference product
Rituxan Hycela rituximab and hyaluronidase human
Genentech, Inc.
- Approved
- Jun 22, 2017
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for rituximab and hyaluronidase human, in chronological order.
Reference approval
Approval date of the reference rituximab and hyaluronidase human product.
9 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
2 yr ago
Frequently asked questions
Are there biosimilars approved for rituximab and hyaluronidase human (Rituxan Hycela)?
No 351(k) biosimilars or interchangeable biosimilars referencing rituximab and hyaluronidase human are listed in the FDA Purple Book yet.
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