retifanlimab-dlwr (Zynyz)
retifanlimab-dlwr is an FDA-licensed reference biologic from Incyte Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Zynyz retifanlimab-dlwr
Incyte Corporation
- Approved
- Mar 22, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for retifanlimab-dlwr, in chronological order.
Reference approval
Approval date of the reference retifanlimab-dlwr product.
3 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 10 mo
Frequently asked questions
Are there biosimilars approved for retifanlimab-dlwr (Zynyz)?
No 351(k) biosimilars or interchangeable biosimilars referencing retifanlimab-dlwr are listed in the FDA Purple Book yet.
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