aldesleukin (Proleukin)
aldesleukin is an FDA-licensed reference biologic from Iovance Biotherapeutics Manufacturing LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1992
Reference approved
Reference product
Proleukin aldesleukin
Iovance Biotherapeutics Manufacturing LLC
- Approved
- May 05, 1992
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for aldesleukin, in chronological order.
Reference approval
Approval date of the reference aldesleukin product.
34 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
21 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for aldesleukin (Proleukin)?
No 351(k) biosimilars or interchangeable biosimilars referencing aldesleukin are listed in the FDA Purple Book yet.
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