inebilizumab-cdon (Uplizna)
inebilizumab-cdon is an FDA-licensed reference biologic from Horizon Therapeutics Ireland DAC. 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
Uplizna inebilizumab-cdon
Horizon Therapeutics Ireland DAC
- Approved
- Jun 11, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for inebilizumab-cdon, in chronological order.
Reference approval
Approval date of the reference inebilizumab-cdon product.
6 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 1 mo
Frequently asked questions
Are there biosimilars approved for inebilizumab-cdon (Uplizna)?
No 351(k) biosimilars or interchangeable biosimilars referencing inebilizumab-cdon are listed in the FDA Purple Book yet.
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