FDA Purple Book · Reference family
ocrelizumab (Ocrevus)
ocrelizumab 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
351(a)BLA 761053
Ocrevus ocrelizumab
Genentech, Inc.
- Approved
- Mar 28, 2017
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ocrelizumab, in chronological order.
Reference approval
Approval date of the reference ocrelizumab product.
9 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for ocrelizumab (Ocrevus)?
No 351(k) biosimilars or interchangeable biosimilars referencing ocrelizumab are listed in the FDA Purple Book yet.
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