ibalizumab-uiyk (Trogarzo)
ibalizumab-uiyk is an FDA-licensed reference biologic from Theratechnologies Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Trogarzo ibalizumab-uiyk
Theratechnologies Inc.
- Approved
- Mar 06, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ibalizumab-uiyk, in chronological order.
Reference approval
Approval date of the reference ibalizumab-uiyk product.
8 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for ibalizumab-uiyk (Trogarzo)?
No 351(k) biosimilars or interchangeable biosimilars referencing ibalizumab-uiyk are listed in the FDA Purple Book yet.
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