zolbetuximab-clzb (Vyloy)
zolbetuximab-clzb is an FDA-licensed reference biologic from Astellas Pharma US, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
Vyloy zolbetuximab-clzb
Astellas Pharma US, Inc.
- Approved
- Mar 24, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for zolbetuximab-clzb, in chronological order.
Reference approval
Approval date of the reference zolbetuximab-clzb product.
1 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 6 mo
Frequently asked questions
Are there biosimilars approved for zolbetuximab-clzb (Vyloy)?
No 351(k) biosimilars or interchangeable biosimilars referencing zolbetuximab-clzb are listed in the FDA Purple Book yet.
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