ravulizumab-cwvz (Ultomiris)
ravulizumab-cwvz is an FDA-licensed reference biologic from Alexion Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Ultomiris ravulizumab-cwvz
Alexion Pharmaceuticals, Inc.
- Approved
- Oct 09, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ravulizumab-cwvz, in chronological order.
Reference approval
Approval date of the reference ravulizumab-cwvz product.
5 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 1 mo
Frequently asked questions
Are there biosimilars approved for ravulizumab-cwvz (Ultomiris)?
No 351(k) biosimilars or interchangeable biosimilars referencing ravulizumab-cwvz 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.