caplacizumab-yhdp (Cablivi)
caplacizumab-yhdp is an FDA-licensed reference biologic from Ablynx NV. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Cablivi caplacizumab-yhdp
Ablynx NV
- Approved
- Feb 06, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for caplacizumab-yhdp, in chronological order.
Reference approval
Approval date of the reference caplacizumab-yhdp product.
7 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 mo ago
Frequently asked questions
Are there biosimilars approved for caplacizumab-yhdp (Cablivi)?
No 351(k) biosimilars or interchangeable biosimilars referencing caplacizumab-yhdp are listed in the FDA Purple Book yet.
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