valoctocogene roxaparvovec-rvox (Roctavian)
valoctocogene roxaparvovec-rvox is an FDA-licensed reference biologic from Biomarin Pharmaceutical Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Roctavian valoctocogene roxaparvovec-rvox
Biomarin Pharmaceutical Inc.
- Approved
- Jun 29, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for valoctocogene roxaparvovec-rvox, in chronological order.
Reference approval
Approval date of the reference valoctocogene roxaparvovec-rvox product.
3 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 2 mo
Frequently asked questions
Are there biosimilars approved for valoctocogene roxaparvovec-rvox (Roctavian)?
No 351(k) biosimilars or interchangeable biosimilars referencing valoctocogene roxaparvovec-rvox 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.